Clinical Trial Jobs in Cambridge.

Parabilis Medicines

View all jobs →

Vice President, Development Data Science

Parabilis Medicines · Cambridge or Remote

Apply now

Development Cambridge Posted May 7, 2026

Why Join Us?

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The VP, Development Data Science will build and lead a cross functional data centric matrix to accelerate drug development, support regulatory submissions and guide the Real-World Data (RWD) / Real-World Evidence (RWE) function at Parabilis. This role is responsible for end-to-end strategy and execution of RWD/RWE and clinical data science to inform trial design, contextualize clinical results, support biomarker and translational work, and optimize site and patient selection.

The VP will partner closely with Clinical Development, Clinical Operations, Biostatistics, Translational/Computational Biology, Regulatory, and the broader Data Science & Engineering team to maximize the probability of success of our clinical programs.

Strategy & Leadership
- Define and own the Clinical Data Science strategy.
- Serve as the senior Clinical Data Science leader and primary point of contact for RWD/RWE across programs aligned with portfolio and corporate objectives.
- Represent Clinical Data Science on cross-functional governance and portfolio forums.
RWD/RWE & Clinical Analytics
- Design and oversee RWE studies to contextualize clinical trials, including synthetic/external control arms, patient matching, and trial emulation.
- Use RWD to inform clinical trial design (eligibility criteria, endpoints, enrichment strategies), dose/regimen selection, and go/no-go decisions.
- Contribute data science insights for feasibility and site selection, including epidemiology, patient journeys, referral patterns, and diversity/access.
- Integrate RWD with internal clinical and biomarker data to support forward and reverse translation, target and indication strategy, and mechanism-of-resistance analyses.
- Establish and maintain best practices in causal inference, comparative effectiveness, and time-to-event modeling relevant to RWE in oncology.
Data Assets, Partnerships & Infrastructure
- Identify, evaluate, and prioritize RWD sources (EHR, claims, registries, genomic/omic datasets, imaging, PROs) to support current and future clinical needs.
- Lead collaboration and contracting with RWD providers and academic/industry partners in coordination with Commercial, Business Development, Legal, and Procurement.
- Partner with Engineering and Data Science to define requirements for secure, scalable, compliant RWD infrastructure and analytic environments.
- Ensure data quality, interoperability, and governance suitable for regulatory-grade analyses.
Team Building & Management
- Build and lead a high-performing Clinical Data Science team (e.g., RWE epidemiologists, clinical data scientists, etc).
- Set clear objectives, provide regular feedback, and support growth and succession planning.
- Foster a culture of scientific rigor, transparency, and effective collaboration with Clinical Development, Biostatistics, and other partners.
Cross-Functional Collaboration & Communication
- Work in an integrated way with Clinical and Development teams to define key questions and translate them into analytic and RWE plans.
- Communicate complex methods, assumptions, and results clearly to clinical, technical, and executive stakeholders.
- Support regulatory and payer/Health Technology Assessment interactions where RWE and clinical analytics contribute to program strategy (e.g., briefing documents, responses, meeting preparation).
- Collaborate with Translational and Computational Biology to align biomarker and patient selection strategies with integrated clinical and RWD analytics.
Governance, Quality & Compliance
- Ensure RWD/RWE activities meet regulatory, ethical, and privacy standards (e.g., GCP, data de-identification and privacy requirements).
- Implement documentation, reproducibility, and quality standards for Clinical Data Science analyses.
- Monitor evolving external expectations for use of RWE in regulatory and payer settings and adapt internal practices accordingly.

What you’ll need to be successful:

PhD, MD, PharmD, or MS in Epidemiology, Biostatistics, HEOR, Data Science, or a related quantitative field.
12–15+ years of experience in pharma/biotech, healthcare technology, or related sectors, with significant focus on RWD/RWE and clinical development; oncology experience strongly preferred.
Proven track record designing and delivering impactful RWE studies to inform clinical, regulatory, or payer decision-making.
Strong understanding of clinical trial design, biostatistics fundamentals, and translational/biomarker concepts, ideally in oncology or immuno-oncology.
Demonstrated experience building, leading, and developing high-performing quantitative teams in a matrixed environment.
Hands-on familiarity with major RWD types (EHR, claims, registries, genomic/omic datasets) and key vendors/platforms.
Proficiency with modern analytic tools and programming environments (e.g., R, Python, SQL) and with guiding development of robust, reproducible analytic workflows.
Excellent communication and influencing skills with the ability to engage effectively with clinicians, statisticians, senior leaders, and external partners.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $325,000-$380,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com

Ready to apply?

Parabilis Medicines

View all jobs →

Real World Evidence/HEOR Contractor

Amylyx Pharmaceuticals · Cambridge, MA

Apply now

320 - Medical Affairs United States Posted May 7, 2026

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

This Real World Evidence (RWE)/Health Economics (HEOR) Contractor role supports the RWE/HEOR Senior Director in leading RWE execution for pipeline assets. The role is fun and flexible with a mix of both study execution and data analytics. This person will be accountable for developing and delivering components of the evidence generation plan (including RWE and economic value evidence), and driving high-quality deliverables that inform internal decision-making during product development, pre-launch readiness, and lifecycle planning. The role is anchored to 1–2 priority pipeline assets/indications.

This is a remote role based with flexible hours. We are currently seeking an individual with 20-30 hours of weekly availability with potential to increase hours in late 2026/2027.

Responsibilities

Evidence strategy and planning: Maintain US RWE & HEOR plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs; translate strategy into actionable workplans, timelines, and resourcing proposals.
Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors.
Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts; ensure adherence to SOPs and high scientific/operational quality.
Analytic execution and statistics: Execute ad hoc analyses in clinical trial, claims and PCOR data as needed for ad hoc and protocol/SAP driven analyses. This may include feasibility or full protocol execution.
Governance, compliance, and capability building: Complete required training, adhere to company/department SOPs, and contribute to continuous improvement of processes that enable efficient planning, execution, and dissemination of RWE & HEOR deliverables.

Required Qualifications

Master’s degree or PhD in epidemiology, health economics and outcomes research, public health, biostatistics, or related discipline.
At least 1+ years of experience in the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application
Proficiency with SAS and/or R for statistical programming. Preference for experience in clinical trials OR claims data.
Expertise in RWE and study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols, reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with ICJME criteria
Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences

Preferred Qualifications

Demonstrated success developing and executing health outcomes research plans and delivering high-quality data generation outputs.
Experience managing real-world data sources and vendors (e.g., claims, EHR, registries) and translating findings into actionable insights and value messages.
Demonstrated ability to influence without authority in a matrix environment, evidenced by aligning cross-functional stakeholders on objectives/trade-offs, documenting decisions, and driving actions to closure.
Experience in PCOR implementation and validation

Work Location and Condition

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location

Compensation

The hourly pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Contractor Hourly Compensation Range

$55—$90 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ready to apply?

Amylyx Pharmaceuticals

View all jobs →

Director, Compliance

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

Legal Cambridge New York Posted May 7, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

Position Overview

We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.

Key Responsibilities

Regulatory Compliance & Risk Management

Experienced with the compliance aspects of clinical trial & clinical research
Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
Monitor evolving AI regulations and their impact on clinical trial optimization platforms

Quality Management & Documentation

Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance
Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection

Contract & Vendor Compliance

Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
Support commercial team with compliance aspects of customer onboarding and due diligence processes

Training & Cross-Functional Support

Develop and deliver compliance training programs for employees across all functions
Serve as primary compliance liaison with external auditors, regulators, and certification bodies
Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
Maintain compliance calendar and ensure timely completion of regulatory filings and renewals

Required Qualifications

Education & Experience

Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
Direct experience with clinical trial regulations and GCP requirements
Proven track record managing compliance programs in regulated industries

Technical Expertise

Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
Financial compliance awareness including regulatory reporting requirements
Deep knowledge of GDPR and HIPAA requirements and implementation
Hands-on experience with SOC 2 audits and information security compliance frameworks
Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
Understanding of AI/ML regulatory landscape in healthcare and clinical trials

Core Competencies

Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
Excellent written and verbal communication skills for regulatory correspondence and training delivery
Project management experience with ability to manage multiple compliance initiatives simultaneously
Detail-oriented approach with strong documentation and process improvement capabilities

Preferred Qualifications

Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
Experience with international regulations (EU Clinical Trials Regulation, other global markets)
Background in clinical research or pharmaceutical compliance
Familiarity with AI ethics and algorithmic bias considerations in healthcare
Experience with healthcare technology or SaaS compliance programs

New York pay range

$160,000—$190,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Regional Director, Sites

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

205000 - Professional Services Cambridge New York US Remote Posted May 7, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

The Regional Director is responsible for owning and optimizing site-level performance across a portfolio of GI-focused clinical research sites. This role ensures operational excellence by aligning teams around key performance goals, elevating site capabilities, and maintaining consistency in trial execution. As a strategic operations leader, the Regional Director plays a central role in connecting site level performance with broader business objectives.

Responsibilities

Manages staff across multiple sites, ensuring execution is aligned with protocol, regulatory requirements, and IH standards.
Owns overall performance of assigned sites, including enrollment, data quality, compliance, and team culture.
Ensures sites are set up for success (i.e. staffed appropriately and equipped with the appropriate equipment and training) and makes recommendations to allocate resources based on business needs.
Builds strong relationships and collaborates with PIs to align their engagement with study goals and operational strategy.
Influences study portfolio, optimizing for profitability and value to patients.
Identifies and manages issues, concerns and problems related to site performance.
Leads and develops CRCs, and other site-based research staff through clear expectations, performance coaching, and team development.
Serves as a visible, hands-on people manager who builds high-performing, accountable teams.
Identifies levers to drive site level KPIs through monitoring KPIs and performance trends, escalating to appropriate parties.
Implements corrective actions or process improvements as needed.
Serves as the primary operational liaison between site staff and central functions.
Drives a culture of ownership, collaboration, and continuous improvement across all assigned sites.

What We’re Looking For

Required Qualifications

Knowledgeable about the critical elements for success in clinical trials: Ability to review protocols, programs, and assess the success of a project.
Ability to influence change management and model flexibility
Problem-Solving Skills: Ability to identify problems, develop and implement solutions.
Strategic Planning: Ability to plan for short, medium and long term success and make recommendations for growth
Ability to use data as a tool, identify trends, and draw conclusions.
Project Management: Demonstrated ability to successfully manage people/projects.
Proactive problem-solving abilities and follow-through.
Practices professionalism and integrity in all actions.
Communication Skills: Excellent written and verbal communication skills.
Working knowledge of CTMS, eDC and other core research systems.
Ability to travel: Up to 30% travel to provide operational oversight, hold team meetings, and attend other professional meetings/conferences as needed.

Preferred Qualifications

Experience in managing a large site network and demonstrated success in achieving targets and optimizing operations.
Experience with gastroenterology and/or hepatology studies.

What We Offer

Medical, dental, and vision insurance
Life and disability insurance
Parental leave
Stock options
Flexible work hours
Unlimited paid time off

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Senior Vice President, Program Leadership & Development

Amylyx Pharmaceuticals · Cambridge, MA

Apply now

120 - Program Management United States Posted May 7, 2026

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Position

Reporting to our Co-CEO’s, the SVP of Program Leadership & Development will drive the advancement of our clinical-stage pipeline. This individual will be responsible for end-to-end leadership of one or more key development programs translating scientific innovation into clinical, regulatory, and commercial success.

The SVP of Program Leadership & Development will play a critical role in shaping program strategy, guiding cross-functional execution, and maximizing asset value from early development through late-stage trials and potential regulatory approval.

This role will serve as a core member of the Senior Leadership Team, partnering closely with Clinical Operations, Medical, Regulatory, Biometrics, CMC, Commercial and other functional leaders to drive the successful execution of Amylyx’s development portfolio.

In a lean and evolving biotech environment, this individual will operate both as an enterprise leader and a hands-on program leader, directly supporting key assets while building a scalable program leadership organization over time.

The Opportunity

This is a unique opportunity to shape and define how program leadership is executed within a growing biotech organization at a critical inflection point.

Build a New Function from the Ground Up - design and implement a modern program leadership model, including the evolution from traditional program management to a strategic Program Lead and Program Manager structure.

Operate as a True Peer to Clinical and Medical Leadership - serve as an equal partner to senior leaders across Clinical Operations, Medical, and Regulatory, helping shape asset strategy and execution.

Drive Impact Across the Full Development Lifecycle - lead programs spanning early-phase IND-enabling work through Phase 3 and potential NDA submission, with direct impact on key value-driving milestones.

Balance Strategy and Execution in a Lean Environment - play a dual role as both a strategic leader and hands-on program leader, directly influencing outcomes while building for future scale.

Shape Organizational Culture and Ways of Working - establish a highly collaborative, accountable, and transparent operating model that strengthens alignment across functions and reduces organizational friction.

Scale with the Portfolio - build and develop a high-performing team over time, aligned to the growth of the pipeline and key clinical milestones.

Responsibilities

Strategic Program Leadership

Partner with Clinical Operations and Medical leadership to define and execute development strategies and plans across programs
Drive program-level decision-making, including risk assessment, trade-offs, and prioritization
Ensure alignment between asset strategy, clinical execution, and regulatory pathways
Present program updates, risks, and opportunities to Executive Leadership and Board of Directors

Cross-Functional Integration & Alignment

Serve as the central integrator across Medical, Clinical Operations, Regulatory, Biometrics, CMC, Commercial and other key functions
Drive clarity of roles, decision-making, and accountability across program teams
Proactively identify and resolve cross-functional misalignment, gaps, and competing priorities

Hands-On Program Execution

Directly serve as Program Lead for one or more key assets, particularly in the early phase of the role
Lead cross-functional team meetings, execution planning, and milestone delivery
Translate strategic objectives into clear, aligned execution plans

Build & Scale Program Leadership

Design and implement a program leadership model, including Program Leads and Program Managers
Hire, develop, and lead program leadership talent over time as the organization grows
Establish best practices, governance frameworks, and ways of working that enable scalability

Portfolio & Executive Contribution

Contribute to portfolio prioritization, resource allocation, and strategic planning discussions at the leadership level
Provide clear, actionable insights and recommendations to executive leadership
Support the evolution of Amylyx’s development organization as it scales toward key clinical and regulatory milestones

Required Qualifications

Advanced degree (PhD, MD, PharmD, or MD) in a relevant scientific discipline preferred; equivalent experience in drug development and program leadership will also be considered
20+ years of experience in the pharmaceutical or biotechnology industry, including significant experience leading cross-functional drug development programs
Lead integrated clinical development plans (CDPs)
Overseen protocol design, endpoints, and trial execution
Demonstrated success in regulatory interactions (FDA, EMA)
Significant experience leading cross-functional drug development programs, ideally spanning early development through late-stage clinical and/or regulatory milestones
Demonstrated success in regulatory interactions (FDA, EMA)
Prior experience serving as a Program Lead, Development Team Leader (DTL), Asset Team Lead or equivalent role, with accountability for cross-functional program execution
Demonstrated ability to partner with Clinical Operations, Medical, and Regulatory leaders as a peer, influencing strategy and execution
Experience operating in a biotech or similarly lean, fast-paced environment, with comfort navigating ambiguity and evolving priorities
Proven track record of building or scaling teams and/or functions within a matrixed organization
Strong leadership and collaboration skills, with the ability to align diverse stakeholders and drive decision-making in complex environments
Hands-on, execution-oriented leadership style, with willingness to engage directly in program delivery when needed
Excellent communication and interpersonal skills, with the ability to bridge scientific, clinical, and business perspectives

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$373,000—$420,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ready to apply?

Amylyx Pharmaceuticals

View all jobs →

Director, Site Performance & Solutions (Cardiology)

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

210020 - Growth Cambridge New York Posted May 7, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

As the Director, Site Performance & Solutions (Cardiology), you will report to the VP, Growth and own the performance of Iterative Health’s central clinical services that are delivered to our cardiology research sites as performance-enabling solutions, including pre-screening, regulatory support, and eSource. Your two core mandates are: owning the operating model for the central research support services we deliver to sites, and ensuring the network consistently hits and improves its activation and randomization targets.

This is a role for someone who is deeply grounded in research operations, relentlessly data-driven, and capable of diagnosing performance improvement opportunities quickly and implementing solutions at a high standard. You will serve as a “product owner” for our suite of site solutions, continuously improving how they are designed and delivered. When performance gaps emerge, you will be the person who figures out what is wrong and drives the fix.

Responsibilities

Network Performance Ownership

Own activation and randomization performance across IH’s cardiology site network as the single accountable leader.
Monitor site and network-level performance metrics continuously, identifying trends, risks, and gaps before they escalate.
Understand the key levers that drive enrollment performance and ensure they are being optimized, consistently and systematically, across the network.
When performance falls short, diagnose root causes quickly, develop a clear plan of action, and drive execution until the issue is resolved.

Operating Model & Solution Ownership

Serve as the accountable owner for IH’s cardiology central research support services, including regulatory support, pre-screening and eSource.
Own the design, execution, and continuous improvement of the operating model for each service, treating them as products with clear performance standards and measurable outcomes.
Define and track service-level KPIs for each function; use performance data to surface improvement opportunities and raise the quality bar.
Develop scalable workflows and best practices that can be deployed consistently across the network.
Serve as the connective tissue between site-level performance trends and central service teams, ensuring the right resources are allocated where they will have the greatest impact.
Collect and synthesize site feedback to inform service improvements and partner with cross-functional teams to implement solutions.

Team Leadership & Management

Directly manage and develop a multidisciplinary team of clinical research specialists, e-source specialists, pre-screeners, and regulatory specialists
Set clear goals and performance expectations for each function, provide ongoing coaching and development, and foster a high-performance team culture
Ensure each team is properly resourced, trained, and equipped to deliver their services at the standard required to drive strong site outcomes

Required Qualifications

BS/BA or higher degree
10+ years of clinical research experience, with deep familiarity with research operations and trial execution
Demonstrated proficiency with clinical research systems and tools, including CTMS and pre-screening workflows
Proven ability to use data to diagnose performance problems, identify improvement opportunities, and drive decisions
Track record of building and improving operating models or service delivery processes in a clinical research context
Proven people management experience, with a track record of leading, developing, and holding accountable clinical research teams
Ability to manage multiple priorities, meet deadlines, and operate effectively in a fast-paced, evolving environment

Preferred Qualifications

Prior experience in a director-level or senior management role within a site network, CRO, or health tech organization
Experience owning enrollment or operational performance metrics at a network or program level
Cardiology-specific clinical research experience

New York pay range

$170,000—$215,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Manager, Growth Operations

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

210020 - Growth Cambridge New York Posted May 6, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

As the Manager, Growth, you will play a critical operational role at the center of Iterative Health's two core growth engines in Cardiology: expanding our sponsor portfolio and scaling our site network. This is a high-visibility, high-impact role for a sharp operator who thrives on process ownership, cross-functional coordination, and getting things done in a fast-moving environment. You will own the internal mechanics of business development — keeping the pipeline moving, deals progressing, and sponsors well-served — while simultaneously driving the operational build-out of new clinical research sites from contract execution through first study activation. The ideal candidate brings a strategic and operational mindset, is energized by variety, and is able to manage multiple workstreams with rigor and speed.

Responsibilities

Sponsor Growth: Business Development & Alliance Management Support

Own the end-to-end internal business development process from initial sponsor engagement through contract execution, serving as the single internal touchpoint for new contracts
Keep the business development pipeline organized and visible by maintaining up-to-date reporting on opportunity status, next steps, and deal progression
Support the Director of Research Partnerships in preparing for key sponsor interactions — developing pitches and proposals, building conference materials, and ensuring the team shows up well-prepared for high-stakes meetings
Support sponsor account meetings through internal data gathering, performance reporting, and post-meeting follow-through
Continuously identify opportunities to streamline and improve the business development process to accelerate deal pull-through and reduce time to contract close

Site Network Growth: De Novo Site Builds

Partner with the Director of Clinical Research to support the end-to-end process of standing up de novo clinical research sites
Serve as the operational connective tissue during site stand-up, tracking progress, surfacing blockers, and ensuring all cross-functional inputs come together on schedule
Work with the Director of Clinical Research to continuously evaluate and improve the site stand-up process — identifying inefficiencies, building out playbooks, and creating repeatable frameworks that scale as the network grows

Required Qualifications

BS/BA or higher degree
4+ years of experience in a strategic and operational role, such as management consulting, business operations, or growth/strategy at a high-growth startup
Demonstrated ability to own and manage complex, cross-functional processes end-to-end with strong attention to detail
Excellent organizational skills with experience managing multiple projects and workstreams simultaneously in a fast-paced environment
Strong communicator with the ability to synthesize information, build materials, and engage effectively with internal and external stakeholders
Comfortable working with ambiguity and building structure where it doesn't yet exist

Preferred Qualifications

Experience in life sciences, clinical research, or healthcare
Familiarity with clinical trial operations, site networks, or sponsor/CRO relationships

New York pay range

$110,000—$140,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Head of Clinical Development

Every Cure · Boston, MA

Apply now

Medical/Clinical Cambridge, Massachusetts Posted May 6, 2026

About Every Cure:

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker, New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H.

Our approach:

AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.
Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.
High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.
Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.
Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact:

Strategic Leadership of Clinical Development and Medical Affairs

Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education

MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
Experience working across more than one therapeutic research area.
Experience with small-sample trial designs and natural history or registry data.
Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills

Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
Exceptional communication and presentation abilities.
Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
Strategic thinker with a focus on urgency, efficiency, and impact.
Passionate about Every Cure’s mission and values.
Highly adaptable, thriving in a fast-paced, start-up environment.
Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits:

Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually.
Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses.
Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future.
Relax and recharge: Generous time off, including paid time off and paid holidays.
We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times.

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

Ready to apply?

Apply to Every Cure

Every Cure

View all jobs →

Senior Manager, Contracts - Clinical

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Legal Cambridge, MA Remote Posted May 6, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Head of Contracts, the Senior Manager, Contracts - Clinical will serve as the primary contracts professional working closely with the Clinical function, particularly Clinical Operations. This is a hands-on, high-volume role responsible for the full lifecycle of clinical site agreements and ancillary clinical contracts across Nuvalent’s global study portfolio, currently spanning four concurrent studies including a Phase 3 randomized controlled trial.

The ideal candidate has deep experience in global clinical site contracting at a sponsor company or CRO, is comfortable operating with significant autonomy, and has the judgment to know when to resolve an issue independently and when to escalate. This role works directly alongside a peer team of Senior Contracts Managers within a contracts department that is growing alongside Nuvalent’s pipeline.

Responsibilities:

Clinical Site & Study Agreements

Draft, review, negotiate, and execute Clinical Trial Agreements (CTAs) with academic medical centers, community research sites, and international investigator sites across global markets.
Manage the full contract lifecycle from initial draft through execution, amendment, and close-out across a high-volume, multi-study portfolio.
Coordinate Informed Consent Form (ICF) review as needed in connection with site-level contracting.
Negotiate and process Work Orders (WOs) and Change Orders (COs) in coordination with Clinical Operations and relevant CRO or vendor counterparties.
Serve as the primary contracts point of contact for site administrators, legal counsel, and CRO contract teams, maintaining productive counterparty relationships through complex negotiations.

Ancillary Clinical Contracts

Draft, review, and negotiate Confidential Disclosure Agreements (CDAs) and Non-Disclosure Agreements (NDAs) for clinical partnerships and site-level engagements.
Manage consulting agreements for clinical investigators, key opinion leaders, and clinical consultants engaged by Clinical and Clinical Operations, with appropriate escalation of HCP engagements for compliance review.
Support statements of work and related agreements for Clinical and Clinical Operations vendors.

Contract Operations & Process

Maintain accurate, complete, and timely contract records in Nuvalent’s contract management system (Agiloft), including status updates, executed document storage, and obligation tracking.
Apply and enforce departmental file naming conventions, version control standards, and repository management protocols.
Provide timely contract status visibility to Clinical and Clinical Operations business owners and serve as a reliable point of contact for internal stakeholders throughout the contract lifecycle.
Identify issues requiring escalation and engage appropriate internal resources — including Legal, QA, Regulatory, Clinical Operations, Finance, IT, and Compliance — or external resources including CRO counterparties, outside counsel, or the Data Privacy Officer (DPO).
Contribute to negotiation playbooks, standard fallback positions, and contract templates for clinical contract types.
Coordinate with Legal and the DPO on data privacy provisions in clinical agreements, including GDPR data processing terms for EU and international site agreements.
Utilize AI-assisted contract review tools as integrated into departmental workflow in accordance with established Nuvalent guidance.
Lead or co-lead department initiatives to support an expanding organization.

Competencies Include:

Detail and process oriented, with strong organizational skills and the ability to manage a high-volume, multi-study contract portfolio across competing deadlines and shifting priorities.
Strong negotiation, problem solving, and communication skills, with the ability to hold a position, find common ground, and close without unnecessary escalation.
Flexibility with changing priorities and ability to think critically under pressure.
Ability to work in a collaborative environment and build effective working relationships across the organization, including with external counterparties such as site administrators, CRO contract teams, and outside counsel.
Sound judgment in recognizing when to resolve independently and when to bring in the right internal or external resources.
Able to thrive in a remote/virtual environment.

Qualifications:

Minimum of 7 years of contracts experience in the biopharmaceutical or clinical research industry, with at least 4 years focused on vendor agreements, clinical site agreements, investigator agreements, or study start-up contracting; sponsor-side experience preferred, CRO-side experience considered.
Demonstrated experience negotiating CTAs, WOs, COs, CDAs, and HCP consulting agreements at volume across multiple concurrent studies.
Direct experience contracting with international clinical sites and working knowledge of applicable legal and regulatory requirements including GDPR data processing considerations.
Working knowledge of GCP, ICH guidelines, and FDA regulations governing clinical research and their practical implications for contract terms.
Familiarity with IRB processes and their intersection with site-level contracting.
Proficiency with contract lifecycle management systems; experience with Agiloft, Ironclad, DocuSign CLM, or comparable platforms required. Agiloft experience a plus; training will be provided.
Oncology experience preferred; relevant experience from adjacent therapeutic areas will be considered.
Familiarity with AI-assisted contract review tools a plus.
Bachelor’s degree or equivalent experience required.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Annual Salary Range

$155,000—$175,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

Senior Manager, Regulatory Affairs

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Regulatory Affairs Cambridge, MA Remote Posted May 5, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Director, Global Regulatory Affairs, the Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA.

The Senior Manager, Regulatory Affairs will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). This role will manage the process for preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development.

The Senior Manager, Regulatory Affairs must be kept current, innovative, and compliant with the constant changing Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA.

Responsibilities:

Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved
As part of the regulatory clinical study team, you will support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.)
Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning)
Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight
Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated.
Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies
Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate
Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required

Competencies Include:

Excellent attention to detail and ability to complete efficient and detailed technical data review
Excellent organization, communication, and multi-tasking skills
Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team

Qualifications:

6-8 years of experience in Regulatory Affairs or combination of education and direct experience.
Bachelor or advanced degree in a scientific field or equivalent work experience is required. Master’s degree a plus.
Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes.
Solid understanding of the e-CTD specifications for electronic submissions.
Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process.
Previous participation in preparing and/or leading regulatory submissions (IND, CTA, NDA, etc.). Experience with preparing meeting packages is a plus.
Experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU.
Strong understanding of regulatory eCTD structure and clinical trial conduct and design
Proficiency with electronic submission publishing software and document management information systems (i.e., docuBridge, Veeva Vault RIM)
Ability to plan, prioritize and contribute to work and projects in a systematic and efficient manner with emphasis on streamlining processes

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Annual Salary Range

$160,000—$185,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

PH

Senior Data Scientist

PhaseV · One Broadway, 11th floor, Cambridge, MA 02142, USA

Apply now

Data Science Boston Office Posted May 4, 2026

Company Overview:

PhaseV (HQ in Boston, R&D in Tel Aviv) is a cutting-edge startup, pushing innovation in the drug development process to bring new treatments to more patients, in a more efficient and precise way. Leveraging the power of advanced causal inference and pushing the boundaries of machine learning, PhaseV detects hidden signals in clinical data and extracts actionable insights for planning the optimal trial. The company's proprietary ML-based platform for adaptive clinical trial design and closed-loop execution enables sponsors to easily and quickly unlock the potential of adaptive clinical trials, reveal the optimal adaptive design to meet their trial objectives and execute more efficient, more precise, and more successful clinical trials. Collaborating with 7 of the top pharmaceutical companies, as well as multiple CROs and biotechs, we are poised to make a significant impact on how drugs are developed and brought to market.

Position Overview:

We are seeking a talented Data Scientist to join our team of researchers. The ideal candidate will have a strong foundation in machine learning and statistics with an interest in causal inference. A couple of recent preprints we’ve released to get a sense of the challenges:

Causal Responder Detection (https://arxiv.org/abs/2406.17571)
Robust CATE Estimation Using Novel Ensemble Methods. (https://arxiv.org/abs/2407.03690)

Key Responsibilities:

Technical Development:

Implement and optimize ML algorithms, with a focus on causal ML applications in clinical trials
Collaborate with senior data scientists to develop and improve our analytical platforms
Work alongside clinical and biological experts to translate complex problems into technical solutions

Research & Analysis:

Conduct rigorous statistical analyses of both randomized and observational data
Develop and validate methods for responder identification and treatment effect estimation
Document and present methodologies and results for internal and external stakeholders

Collaboration:

Work cross-functionally with engineering and product teams
Contribute to technical discussions and peer code reviews
Support the preparation of technical documentation and research papers

Qualifications:

Education:

Master's in Computer Science, Statistics, Data Science, Engineering or a related field
Ph.D. is an advantage but not required

Experience:

3+ years of experience in data science or machine learning roles
Experience with ML in a practical research or industry setting
Background in statistical modeling and analysis

Skills:

Strong programming skills in Python (R in addition - an advantage)
Proficiency in statistical analysis and machine learning
Experience with data visualization and communication of technical concepts
Strong analytical and problem-solving skills

Preferred:

Familiarity with causal inference concepts
Experience in healthcare or biotech industry
Experience with large-scale data processing

What We Offer:

Join us on a mission to bring more effective drugs to more patients.
The opportunity to work with an amazing team passionate about making a real-world impact.
Extremely hard and diverse problem setting, in which the team is pushing the envelope.
A collaborative and dynamic startup environment.
Professional growth and development opportunities.

Ready to apply?

Apply to PhaseV

PH

PhaseV

View all jobs →

Associate Medical Director, Drug Safety and Pharmacovigilance (PV)

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Pharmacovigilance Cambridge, MA Remote Posted May 1, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

Responsibilities:

Provide medical expertise in the assessment of ICSRs
Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Provide safety and pharmacovigilance training programs as required
Collaborate cross functionally (e.g. Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

Strong written/verbal communication skills.
Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
Detail and process orientated, with excellent project management, problem solving, and organization skills.
Ability to think critically with strong attention to detail.
Demonstrated project management and prioritization capabilities

Qualifications:

4+ years’ experience in Drug Safety / Pharmacovigilance in a Biotech / Pharma company
8+ years of industry (Biotech / Pharma) experience
Healthcare degree required / Medical Degree (MD) from recognized medical school preferred.
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
Ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
Excellent verbal, written and presentation skills

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Annual Salary Range

$210,000—$235,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

Associate Director, Drug Safety and Pharmacovigilance Scientist

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Pharmacovigilance Cambridge, MA Remote Posted Apr 30, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

Responsibilities:

Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Contribute to signaling and safety surveillance processes, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Provide safety and pharmacovigilance training programs as required
Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
Support the medical assessment of ICSRs as needed
Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

Design global risk management frameworks for Nuvalent’s medicines
Translate safety data into clinical insights
Adapt visualization tools for safety surveillance
Influence multidisciplinary teams to prioritize patient safety.
Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders

Qualifications:

4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
7+ years of Pharma / CRO experience.
Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
Experience with safety data collection and interpretation from clinical trials, literature and post market
Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
Experience with the development and updates to Reference Safety Information, IB, Company Core Data Sheet and local labels
Excellent verbal, written and presentation skills

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Annual Salary Range

$170,000—$195,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

Sr. Clinical Research Coordinator, Clinical Operations

Prime Medicine · Watertown, MA

Apply now

Clinical Cambridge Posted Apr 30, 2026

Company Overview:

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.

Position Overview:

Join a collaborative, agile and dynamic Clinical Development Operations (CDO) team by leading and contributing to transformative clinical programs for patients in rare diseases and beyond.

In this position, you will be hands-on in day-to-day study execution, working closely with internal study team members, clinical sites, and external CROs and vendors. This position is ideal for someone who thrives in a fast-paced, evolving environment, is comfortable wearing multiple hats, and is eager to learn more about clinical trial management and execution. This is a hybrid role requiring a combination of in-office presence (Watertown, MA) and remote work, with expectations aligned to team and business needs.

Key Responsibilities:

· Support the execution of clinical trials from startup through closeout, ensuring adherence to protocol, timelines, and quality standards

· Assist with site startup activities, including regulatory document collection, IRB/EC submissions, and site readiness/activation

· Support development of study and site-facing materials (e.g., ICFs, recruitment materials, study manuals, CCGs, study tools) and coordinate cross-functional review and approval

· Prepare and maintain meeting minutes, action items, and follow-ups for key study team meetings

· Maintain study documentation (e.g., sponsor TMF oversight and ISF support) to ensure completeness, quality, and inspection readiness

· Oversee CRO/vendor TMF activities, ensuring alignment with sponsor expectations, TMF plans, and filing timelines

· Track study progress, enrollment, IRB/EC submissions and queries, and key operational metrics; proactively identify and escalate risks to timelines or deliverables

· Serve as a primary point of contact for CRAs and sites to address day-to-day operational questions and issues

· Track and monitor key subject visits and study milestones to ensure protocol compliance and data integrity

· Support inspection readiness activities, including TMF reviews, audit support, and resolution of findings

· Support clinical sample management activities, including coordination of central labs, sample logistics, tracking, and issue resolution

· Review clinical data, monitoring reports, and protocol deviations to ensure quality, compliance, and timely issue resolution

· Contribute to SOP development, process improvements, and operational best practices within a growing organization

Qualifications:

· BS/BA/RN Degree in science or a health-related field is preferred

· Minimum 2–4 years of clinical research experience; sponsor experience is strongly preferred.

· Familiarity with clinical trial operations, ICH-GCP, and regulatory requirements

· Experience and understanding of EDC systems, TMF systems, and clinical trial documentation

· Familiarity with clinical data review and data management processes, including Data Monitoring Committees

· Highly organized with strong attention to detail

· Ability to manage multiple priorities with a sense of urgency in a fast-paced environment

· Strong communication and relationship-building skills

· Resourceful, proactive problem-solver with a “do-what-it-takes” mindset

· Comfortable operating in a dynamic environment with evolving processes and priorities

· Self-motivated, collaborative, and able to work both independently and cross-functionally

· Positive, team-oriented attitude with a passion for advancing innovative therapies for patients

· Excitement to contribute to Prime Medicine’s culture!

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

U.S. Pay Range

$94,000—$114,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

Ready to apply?

Apply to Prime Medicine

Prime Medicine

View all jobs →

Senior Manager, Supply Chain

Parabilis Medicines · Cambridge, MA

Apply now

Technical Operations Cambridge Posted Apr 29, 2026

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and AR^ON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The Senior Manager, Supply Chain will lead the end-to-end operational management of investigational product (IP) and clinical trial materials across global Phase I–III studies. This role is responsible for ensuring timely, compliant, and efficient delivery of clinical supplies, while partnering cross-functionally with Clinical Operations, Quality, Regulatory, CMC, and external vendors to support study execution.

Develop and maintain study-level supply plans and forecasts aligned with enrollment, protocol design, and site activation timelines
Coordinate packaging, labeling, release, and global distribution of investigational products and ancillary materials
Oversee inventory across depots and study sites, proactively mitigating risks to avoid shortages or excess
Serve as business owner of the IRT system, including setup, configuration, validation, and ongoing management
Partner cross-functionally to align supply strategy with clinical and regulatory requirements and ensure seamless execution
Author and maintain supply-related documentation, including SOPs, Pharmacy Manuals, and study-specific materials
Ensure compliance with GxP, GDP, and ICH-GCP standards, supporting audits and inspection readiness
Manage global logistics, vendor oversight, and third-party partners to ensure uninterrupted supply across regions

What you’ll need to be successful:

Bachelor’s degree in Supply Chain, Life Sciences, or related field (Master’s preferred)
Minimum 5 years of global clinical supply chain experience within biotech, pharma, or medical device
Hands-on experience with IRT/IXRS systems (e.g., 4G Clinical, Almac, Endpoint)
Experience supporting global Phase I–III clinical trials (commercial launch experience preferred)
Proficiency with Microsoft Office and inventory/ERP systems
Strong understanding of GxP, GDP, and ICH-GCP regulations
Proven ability to manage complex global supply operations and mitigate risk
Strong analytical, organizational, and problem-solving skills
Effective cross-functional collaboration and communication across internal teams and external partners
Experience drafting SOPs, Pharmacy Manuals, and clinical supply documentation preferred
Familiarity with cold chain and temperature-controlled distribution preferred
APICS/CSCP or PMP certification a plus
Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus
Able to work on-site and attend in-person meetings
Ability to travel up to 15%

Core Values

Parabilis is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
In(ter)dependent.We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
Patient-focused.We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
All-In.We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary target for this position is $153,000-$180,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com

Ready to apply?

Parabilis Medicines

View all jobs →

BE

Vice President, Compliance

Beam Therapeutics · Cambridge, MA

Apply now

Legal Beam - Cambridge Posted Apr 29, 2026

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Vice President, Compliance is a strategic leader responsible for designing, implementing, and continuously improving the company’s Corporate Compliance Program to oversee promotional materials, field training, and HCP/patient programs. As an objective advisor, the Vice President, Compliance ensures the organization operates with integrity and in compliance with all applicable laws, regulations, and internal policies. Reporting to the Chief Legal Officer, the Vice President, Compliance partners with executive leadership, the legal and compliance function, the Audit Committee of the Board of Directors, and employees at all levels to foster a culture of ethical conduct and accountability.

Beam is transitioning to a commercial stage company, and this position plays a critical role in developing a culture of compliance. Additionally, ex vivo cell therapy and in vivo gene therapy have unique commercial and operational needs that require a strategic leader to collaborate with commercial, medical, and manufacturing to build a commercial process that delivers for patients compliantly.

Key Responsibilities:

Develop, execute, and evolve a comprehensive compliance strategy and program focusing on healthcare compliance and aligning with business objectives and legal requirements that meets the unique needs of cell and gene therapy.
Provide proactive strategic advice to the business to help drive commercial success and ensure compliance with applicable laws and company policies, including federal and state anti-kickback and false claims laws; U.S. and other country anticorruption laws; the federal Food, Drug and Cosmetic Act; and federal and state transparency laws.
Serve as Chair of the Beam Compliance Committee and as Data Privacy Officer.
Provide regular updates on the Compliance Program to executive leadership and the Audit Committee of the Board of Directors.
Review business strategy plans and business development opportunities for compliance risks and advise the business on how to mitigate those risks.
Develop and maintain trusting relationships with key client groups, such as commercial and clinical, and serve as a trusted and strategic advisor and resource.
Act as a compliance champion to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel.
Champion open communication by ensuring employees feel empowered to raise concerns without fear of retaliation.
Oversee ongoing education initiatives to enhance understanding of the Code of Business Conduct & Ethics, Beam policies and procedures, and emerging compliance risks, and seeking opportunities for continuous learning across the organization.
Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics. Identify gaps and support the design and tracking of corrective actions to strengthen compliance controls.
Manage and conduct compliance investigations, working with internal business partners to identify appropriate corrective and preventive actions.
Stay ahead of regulatory and industry code changes and industry and enforcement trends impacting compliance areas and proactively advise leadership on potential impacts and necessary adaptations.
Serve as a trusted advisor to the Board of Directors, Chief Legal Officer, executive leadership team, and other functions, providing actionable guidance on compliance matters and risk mitigation.
Engage with outside counsel, regulatory agencies, and industry groups to understand and benchmark the best practices and ensure the compliance regime meets or exceeds industry standards.

Qualifications:

Bachelor’s degree required, Juris Doctorate or advanced degree a plus.
Cell and gene therapy experience a must.
Relevant experience (typically 7 years or more, or equivalent combination of education, training, and experience) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry.
Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.
Demonstrated effectiveness operating in complex organizational and regulatory environments and experience with Code implementation (PhRMA, EFPIA, IFPMA)
Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical industry including sales and marketing, OIG and other industry guidance documents, regulations on the promotion of marketed products, clinical trial regulations, patient privacy and issues arising under the False Claims Act, anti-bribery/anti-corruption laws, and other related laws.
Business focused and solution oriented.
Excellent written, oral and presentation skills.
Proven ability to work with all levels of management.
Strong problem-solving and analytical skills.
Self-motivated and able to perform role independently, with a minimum level of supervision.
Demonstrated ability to partner effectively with others in addressing complex issues.
Strong influencing skills and sound business judgment.
Ability to appropriately prioritize issues.
Outstanding attention to detail.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range

$310,000—$400,000 USD

Ready to apply?

BE

Beam Therapeutics

View all jobs →

Director, Clinical Sciences

Amylyx Pharmaceuticals · Cambridge, MA

Apply now

311 - Clinical Development United States Posted Apr 28, 2026

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Director Clinical Science will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will report to a Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).

Responsibilities

Collaborates with the clinical development team in review, analysis, and interpretation of study results.
Provides scientific support on ongoing Phase I to III clinical trials and contributes to the planning and design of upcoming clinical studies.
Performs monitoring and review of study data including labs, safety data, and patient eligibility.
Authors and/or reviews clinical trial-related documents including protocols, CRF, informed consent, protocol deviations, monitoring plans and regulatory documents, etc.
Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs.
Interacts with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.

Required Qualifications

Advanced degree (M.D., Ph.D., Pharm.D., Master’s Degree in Science/Medical-related field).
MD, PhD or PharmD with 3+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master’s degree with 8+ years of relevant experience.
Knowledge of Phase 1-3 drug development.
Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
Prior experience working within neurology or neurodegenerative indications.
Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations.
Strong, collaborative team-player.
Excellent attention to detail and communication skills.

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$210,000—$228,300 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ready to apply?

Amylyx Pharmaceuticals

View all jobs →

VE

Contract - Senior Quality Control Specialist

Vedanta Biosciences · Cambridge, MA

Apply now

Quality Control Cambridge Posted Apr 28, 2026

Title: Contract - Senior Quality Control Specialist

Location: Cambridge, MA - onsite

Reports to: Senior Manager, Quality Control

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

This position directly supports Vedanta’s in-house cGMP manufacturing capabilities. This role will be lab-centered and focused on Drug Product and Drug Substance testing for release and stability. In addition to performing testing, this role will participate in the management of the Quality Control laboratory with daily responsibilities including routine lab testing, inventory management, and data reporting.

There will be collaboration with Analytical Development, Quality Assurance, and Production departments to support cGMP manufacturing, Process Validations, and Analytical Testing Validations.

A successful candidate for this role will have strong attention to detail, good organizational skills, and be a quick learner. They will be able to exercise judgment within defined procedures and practices to determine appropriate action and ask questions if the path forward is unclear, follow routine procedures, apply learned techniques, and contribute to analysis and investigation to solve problems. An ideal candidate will be a strong independent worker, able to self-organize and execute day-to-day work autonomously.

Previous experience with hands-on laboratory testing in a microbiology laboratory, aseptic technique, qPCR, pipetting, and general USP microbiological is required. Experience with chemistry testing and data review preferred.

This role will require being on-site full-time in Cambridge.

Here’s What You’ll Do:

Perform routine microbiology testing to support release and stability of Vedanta products
Perform testing to support assay validation activities
Review test lab data, protocols, reports, and quality events (deviations, OOS etc.)
Author, review, and revise SOPs, protocols, and reports
Participate in continuous improvement projects to support the growth of the company
Participate within the QC team to meet group and company goals

Requirements:

BS in a scientific discipline
Minimum 5+ years working in a GMP environment and/or Quality Control test lab
Direct, hands on, experience with PCR/qPCR testing
Direct experience with aseptic sampling and testing techniques
Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work independently and within a team environment
Experience working within QMS systems, deviation investigations, OOS, CAPAs and Change Controls
Experience with QC continuous improvement projects; project management skills a plus
Proficient in Outlook, MS Word, Excel, and lab-based data management systems
Knowledge of FDA and EU compliance principles
Knowledge of USP and ICH guidance preferred

The base pay range for this position is expected to be $46-53 per hour; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities.

Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

Ready to apply?

Apply to Vedanta Biosciences

VE

Vedanta Biosciences

View all jobs →

Clinical Research Finance Specialist

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

Finance & Accounting Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

We are seeking a motivated and detail-oriented Clinical Research Finance Specialist to join our growing Finance team. This role partners closely with the Finance Manager to support end-to-end accounts receivable operations across sponsor-funded clinical studies and internal research sites.

You will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. This role requires close collaboration with internal teams, research sites, and sponsors and CROs to ensure accurate billing, timely cash application, and prompt resolution of outstanding balances.

The ideal candidate thrives in a fast-paced clinical research environment and enjoys balancing hands-on execution with cross-functional collaboration and continuous process improvement.

Key Responsibilities

Support day-to-day accounts receivable operations, including monitoring sponsor and site-level balances and assisting with timely collections
Reconcile study-level balances and payment activity, identifying discrepancies and partnering with stakeholders to resolve issues
Accurately post cash receipts and payment details in RealTime CTMS and related financial systems
Prepare and issue invoices for study activities and services in coordination with sponsor communications and internal teams
Communicate professionally with sponsors and CROs regarding billing questions, payment status, and outstanding balances
Assist in the preparation of AR aging schedules, financial summaries, and internal reporting
Support audits and financial reviews related to accounts receivable and billing activity
Collaborate cross-functionally with Clinical Operations, Site Finance, and Accounting to clarify billing terms and deliverables
Contribute to ongoing process improvements to enhance AR efficiency, accuracy, and visibility
Provide general finance support as needed to ensure smooth AR operations

Required Qualifications

Bachelor’s degree in Finance, Accounting, Business, or a related field (or equivalent practical experience)
2+ years of experience in accounts receivable, billing, or finance operations
Strong proficiency in Microsoft Excel, including data analysis and reporting
High attention to detail with the ability to manage multiple priorities and deadlines
Excellent written and verbal communication skills, with a professional approach to external stakeholders

Preferred Qualifications

Experience with RealTime CTMS or similar clinical trial management and billing systems
Background in healthcare, clinical research, or multi-site organizations
Familiarity with sponsor contracts, clinical trial invoicing, or study-level financial reconciliation

New York pay range

$75,000—$85,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Clinical Contracts Specialist

Iterative Health · Cambridge, MA, New York, NY

Apply now

Legal Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

We're looking for a driven, detail-oriented Clinical Contracts Specialist to join our small but mighty Legal team. In this role, you will manage and negotiate clinical trial agreements with sponsors and biotech partners, serving as a key point of contact throughout the contract lifecycle. Through your organization, communication skills, and daily dedication, you will have a meaningful impact on the success of our clinical partnerships and, ultimately, on the patients we serve.

Responsibilities

Draft, review, and negotiate clinical trial agreements (CTAs), confidentiality agreements (CDAs), and related documents with sponsors and biotech partners
Serve as the primary point of contact for external parties on contract status, redlines, and execution timelines
Manage the contract lifecycle in Ironclad, including tracking pending agreements, maintaining version control, and ensuring timely follow-ups
Route finalized agreements for signature and maintain organized records of executed contracts
Collaborate with clinical, business development, and finance teams to align contract terms with operational and budgetary requirements
Identify and escalate contractual issues or non-standard terms to the Director of Legal for resolution
Drive excellence and efficiency by maintaining templates, playbooks, and standard operating procedures for clinical contracting
Support audit and compliance requests by ensuring contract documentation is complete and accessible

What We're Looking For

Bachelor's degree in Life Sciences, Legal Studies, Business, or a related field
3+ years of experience negotiating or administering clinical trial agreements, preferably within a sponsor, CRO, or healthcare technology company
Proficiency with contract lifecycle management systems (Ironclad preferred; Agiloft, Concord, or similar acceptable)
Strong understanding of clinical research processes and regulatory considerations (e.g., ICH-GCP, HIPAA)
Excellent written and verbal communication skills with the ability to manage multiple external stakeholders
You are highly organized and adept at managing time-sensitive work streams and competing priorities
You are a team player who dives head first into accepting diverse and challenging assignments with rigor and tenacity
You have high integrity and excellent judgment

What We Offer

Medical, dental, and vision insurance
Life and disability insurance
Parental leave
Stock options
Flexible work hours
Unlimited paid time off

Our Commitment to Diversity

At Iterative Health, we're building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.

New York pay range

$100,000—$120,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Clinical Data Specialist - Site Operations

Iterative Health · Cambridge, MA or New York City, NY

Apply now

205000 - Professional Services Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

At Iterative Health, we are pioneering the application of powerful, proprietary artificial intelligence tools to the practice of gastroenterology, cardiology, and drug development. We’ve set out to drastically improve clinical decision-making while meaningfully improving patient lives through better diagnosis, disease management, and treatment, leading to better health outcomes.

The Clinical Data Specialist is responsible for supporting our clinical trial service operations through performing EHR chart review to identify patients who are candidates for clinical trials.

What you’ll be doing:

Support research sites within the Iterative Health network by reviewing the electronic health records
Building a database of potential study candidates
Read and understand each assigned protocol to understand the applicable protocols and criteria of studies to determine specific patient population needs
Maintain documentation to track findings from Patient Pre-Screening
Attend project meetings as needed
Perform administrative duties in conformity with company policies and procedures

Required Skills:

Experience and competency in common office tools such as internet browsers, Adobe Acrobat, Microsoft Office (Word, Excel, PowerPoint), Google Workspace (Email, Drive, Sheets, Docs) and messaging platforms (Slack)
Ability to quickly learn new systems and platforms such as Electronic Health Record systems, Customer Relationship Management systems (Salesforce) and clinical trial management systems (ie CTMS)
Thrives when working within a high-paced, fluid environment
Excellent time management, planning, and organizational skills are required
Attention to detail and thorough follow-up skills
Capable of handling and interacting with data in a confidential and compliant manner
Excellent written and verbal communication skills
High level of tact, integrity, and professionalism

Preferred Qualifications:

Clinical Research sector experience preferred
Familiarity with reading and understanding clinical research manuscripts and protocols
Familiarity with reviewing electronic health record data
Familiarity with GCP guidelines
Experience within a healthcare start-up preferred

New York pay range

$60,000—$70,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Clinical Operations Manager(Biological Sample Clinical Trials)

Iterative Health · Cambridge, Massachusetts, Dallas, Texas New York, New York

Apply now

210020 - Growth Cambridge New York Dallas, Tx Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

As the Clinical Operations Manager, you will report to the VP, Growth and work closely with our Clinical Research and Life Sciences teams to integrate Iterative Health (IH) services and AI solutions at clinical research sites throughout the US. This external-facing role will require strong communication, customer engagement and deep expertise in clinical research, in addition to a strong strategic skill set. You will engage with partners such as sponsors, CROs and key sites to drive executive operational alignment, providing strategic recommendations both internally and externally with a focus on improving research operations focused on biological sample collections trials. You’ll also be working directly with your portfolio of sites to deliver day-to-day support that encourages research best practices, drives the adoption of IH services and products, and ensures our sites achieve their research goals.

Key Responsibilities:

Own end-to-end clinical research operations for biological sample collections trials, serving as the primary accountable party for trial execution quality and sponsor satisfaction outcomes
Build and manage DCT (decentralized clinical trial) vendor relationships, including performance management, metrics tracking, and oversight to ensure biological sample collections trial delivery
Own the information flow between sites and sponsors - including internal study education, site engagement protocols, and issue escalation pathways
Serve as leading sponsor-facing owner for active studies - leading alliance management meetings by providing study updates, reviewing metrics, discussing site accomplishments and ongoing issues, and gathering information to relay to site-based staff, driving sponsor satisfaction, and owning escalation resolution
Drive direct QC enforcement with site CRCs/staff, including data quality expectations-setting and direct communication on compliance gaps
Own site performance improvement through metrics, change management, and direct intervention - proactively identifying and resolving performance gaps before sponsor escalation
Demonstrate advanced knowledge of clinical research processes and tools, such as CTMS, pre-screening, and/or feasibility, and enhance these processes and outputs to effectively support our sites or internal teams.
Serve as a subject matter expert on clinical research workflows, in line with specific requirements of each protocol, optimized with Iterative Health (IH) services and AI solutions
Support and lead weekly meetings with site-based staff to review enrollment progress, address operational issues, and provide guidance for performance improvement.
Manage customer relationships with a high degree of professionalism and expertise ensuring timely responses, escalations of site issues, and building trust needed to help sites achieve IH goals
Leverage IH solutions and services to help build best practice research sites, accelerate clinical trials, and build capacity at IH sites to execute high-quality clinical trials.
Deliver customized training for different clinical research user groups and devise process maps/workflows, tools, and techniques to help sites incorporate IH services
Travel to customer sites to support study site activation, drive patient screening, and standby support for randomization activities
Collect, analyze, and communicate the voice of IH customer successes, concerns, and product adoption issues/competency gaps and collaborate with IH cross-functional teams to design and deliver solutions

Required skills:

BS/BA or higher degree.
Minimum 4 years of clinical research coordinator experience
At least 8 years of experience with biological sample collection trials and/or phase 2-4 pharma-sponsored clinical trials, including study start-up, CDA, feasibility, regulatory/standard operating procedures, study protocols, and regulations governing clinical research
Experience coordinating, evaluating, and following patients’ participation through clinical trials.
Fluent in the use of Microsoft Office/Google Apps products.
Ability to navigate ambiguity and willingness to be flexible/adapt to changing work environments.
Desire to work with new tools and technology
Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately.
Willingness to travel to customer sites (~30%)

Preferred skills:

5+ years as a Clinical Research Coordinator (CRC) working with biological sample collections trials or equivalent experience
Experience with CTMS systems - preferably RealTime, Clinical Conductor, or CRIO

New York pay range

$125,000—$150,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Clinical Research Systems Specialist

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

210020 - Growth Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

Iterative Health is pioneering the use of artificial intelligence-based precision medicine in cardiology, with the aim of helping to optimize clinical trials. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way.

The Clinical Research Systems Specialist is responsible for supporting our clinical trial service operations through the development, maintenance, and quality assurance of administrative clinical trial materials.

What you’ll be doing:

Perform and maintain study builds within CTMS system(s)
Support clinical research sites within their CTMS
Support Clinical Research Specialists & clinical research sites in EHR prescreening and management of Patient Findings Report
Conduct quality review and user acceptance testing of study builds to ensure alignment with protocol, sponsor requirements, and internal standards
Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities
Provide QC support for budget and contract team
Attend project meetings as needed
Read and understand each assigned protocol
Provide regular reports to advise leadership of quality issues and to guide process corrections & improvements
Perform administrative duties in conformity with company policies and procedures
Partner cross-functionally with clinical operations, regulatory, finance, and site teams to support study launch and execution.

Required Skills:

Clinical Research Coordinator experience
Experience with CRIO, RealTime CTMS or similar clinical research technology platforms
Attention to detail and thorough follow-up skills
Capable of handling and interacting with data in a confidential and compliant manner
Ability to competently use and learn software such as internet browsers, Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and clinical trial management system (CTMS)
Intellectually curious
Hardworking, forward-thinking, credible, conscientious, and creative
Thrives when working within a high-paced, fluid environment
Excellent time management, planning, and organizational skills are required
Excellent written and verbal communication skills
High level of tact, integrity, and professionalism

Preferred Qualifications:

Experience within a healthcare start-up preferable
Experience reading and understanding clinical research manuscripts and protocols
Experience with vendor management
Familiarity with ICH GCP/GDP guidelines
Familiarity with the following study documents: Budgets, CTAs, eCRF guidelines, lab manuals, pharmacy manuals, informed consent forms, annotated CRFs, etc.

New York pay range

$70,000—$90,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Manager, Pre-Screening

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

205000 - Professional Services Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

The Manager, Pre-Screening owns the top of the patient funnel for Iterative Health studies, including leading indicators on screenings, randomizations, and funnel volume / health. They will manage a team who performs EHR chart review to identify potential candidates for trial enrollment and are responsible for ensuring that every trial Iterative Health supports receives the right pre-screening support.

Responsibilities

Execute human-in-the-loop component of EHR chart review and patient identification
Develop and standardize EHR chart review processes and define metrics to measure quality
Read and understand assigned study protocols to develop pre-screening approach and train team against
Own strategy to increase impact of EHR chart review
Ensure team achieves high performance on key success metrics and make recommendations on how to scale team capacity
As needed, provide coverage for team and perform EHR chart review
Support team members by resolving immediate issues and providing first-level guidance
Own requirement development with Product team related to technologies developed for pre-screening

What We’re Looking For

Required Qualifications

Experience managing a team
Familiarity with clinical research protocols and manuscripts
Experience with Electronic Health Records systems
Exceptional attention to detail and follow-up skills
Ability to handle and interact with confidential data securely and compliantly.
Proficiency in software such as internet browsers, Adobe, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams), and Salesforce

Preferred Qualifications

Clinical Research sector experience preferred
Familiarity with reading and understanding clinical research manuscripts and protocols
Familiarity with reviewing electronic health record data
Past experience working with Product teams to develop user requirements
Experience within a healthcare start-up preferred

What We Offer

Medical, dental, and vision insurance
Life and disability insurance
Parental leave
Stock options
Flexible work hours
Unlimited paid time off

Our Commitment to Diversity
At Iterative Health, we’re building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.

New York pay range

$97,000—$110,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Staff Data Engineer

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

Engineering Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're building a uniquely valuable data asset: real-world patient and research data flowing across 80+ trial sites, spanning dozens of EHRs and clinical systems, focused on patient populations that are chronically underserved by existing clinical research infrastructure. Your job is to build the pipelines, data models, and AI infrastructure that make this asset real, from ingestion and normalization through to the systems that power predictions on top of it. You'll own data quality and observability as foundational engineering problems. You'll also have a direct hand in shaping how this data drives our AI strategy, what we model, what we predict, and what becomes possible.

This is an opportunity for someone who wants to be part of a small, fast-moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

Own the data layer and architecture: the models, schemas, and infrastructure decisions that everything downstream depends on
Build and operate the pipelines and transformations that move data from ingestion through normalization, enrichment, and into the formats that support analytics, ML training, and production model serving
Own data quality and observability: build the systems that make data issues visible and correctable before they compound
Partner with ML and engineering teams to identify what's modelable, define training data requirements, and build the data foundations for new predictive capabilities
Define how clinical and operational data is governed across the system
Evaluate and select the tools and technologies that make up the data stack, with a clear point of view on build vs. buy
Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

10+ years of experience in data engineering or related roles, with significant time spent building data systems
Experience with healthcare data strongly preferred (HL7, FHIR, claims, EHR extracts) or other complex, regulated data domains
Deep experience modeling and integrating data from multiple heterogeneous sources with inconsistent schemas and quality
Experience applying AI and LLMs to data engineering problems: extraction, normalization, classification, entity resolution
Strong understanding of how data infrastructure supports ML workflows from feature engineering to training data pipelines to model serving
Fluent in SQL and at least one modern programming language (Python, Java, Scala, Go), with experience across modern data infrastructure - distributed processing, streaming, cloud-native storage, orchestration, and transformation frameworks
Have built data systems from early stages, making foundational decisions with incomplete information
Naturally raise the quality of the engineering around you through code review, design guidance, and honest technical conversation

Preferred Qualifications

Experience building data infrastructure that directly supports ML model training and evaluation
Familiarity with clinical trial operations, EDC systems, or life sciences data
SOC 2, HIPAA or similar compliance experience baked into engineering practice
A track record of building or improving data systems that others had given up on making reliable

New York pay range

$200,000—$325,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Staff Data Scientist

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

Engineering Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're looking for a Staff Data Scientist to be the person who understands our data deeply enough to know what's possible and curious enough to prove it. We have a truly unique data set within the industry, connecting clinical data (emr, endoscopic video, etc…) to trial data across 80+ trial sites. We're looking for someone who wants to dig deeply into this data - to understand its structure, its gaps, what it can tell us - and connect that understanding to real outcomes for sites and patients. The landscape is evolving rapidly, and the right person will have a point of view on how to apply new capabilities to our specific data and problems as they emerge.You'll work hands-on with the data, structure experiments, evaluate what's modelable, and directly influence what we build and how. This role sits at the intersection of data science, product strategy, and ML: you'll lay the foundation for our predictive capabilities and shape what that function becomes.

This is an opportunity for someone who wants to be part of a small, fast-moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

Work with clinical, video, and clinical trial operational data to understand what's there, what's meaningful, and how we can use it to drive a more efficient clinical trial system
Design and run experiments that determine what's worth building
Stay close to the evolving ML and model landscape and bring a point of view on how new capabilities apply to our data and problems
Define the path from raw data to product and operationalization: what to model, how to evaluate it, and when it's ready to ship
Partner with product and engineering to translate findings into concrete product decisions
Identify opportunities where our data creates unique predictive advantages
Evaluate where we should build, where we should partner, and where existing approaches fall short
Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

5+ years of experience in data science, applied ML, or quantitative research, with significant time spent hands-on with data
Experience with healthcare data, clinical research, or life sciences
A deep curiosity to understand data and connect it to the real world
Deep experience designing and running experiments: you know how to structure a question, test it honestly, and draw conclusions that hold up
Strong statistical foundations and the judgment to know when a result is meaningful versus interesting
Fluent in Python and SQL, comfortable working across the data stack from exploratory analysis through to production-ready pipelines
Experience working across data science, product, and engineering: you can influence what gets built, not just analyze what exists
Have worked with complex, messy, real-world data and know how to make it useful without pretending it's clean
Knowledgeable about ML capabilities and frameworks, with the judgment to know when something is genuinely applicable versus hype
Can communicate findings clearly to technical and non-technical audiences, and make a persuasive case for what to build next

Preferred Qualifications

Experience working at growth stage startups (strongly preferred)
Experience with medical imaging or video data
Familiarity with clinical trial operations, disease classification, or patient identification problems
Experience building or defining the roadmap for an ML function from early stages
- A track record of data science work that directly changed product direction

New York pay range

$200,000—$325,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Staff Software Engineer

Iterative Health · Cambridge, Massachusetts, United States, New York, New York, United States

Apply now

Engineering Cambridge New York Posted Apr 28, 2026

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're looking for a Staff Software Engineer to own the design and implementation of the core systems that make this possible. This means building robust integrations across a complex, fragmented landscape of EHRs, CTMS platforms, and clinical data sources, each with its own data models, access patterns, and operational constraints. It also means building the data infrastructure that powers our predictive capabilities: the pipelines, feature stores, and training infrastructure that allow us to move from raw clinical data to models that meaningfully improve trial execution. This is a generalist role for someone who thinks in systems. You'll move between architecture and implementation, between integration engineering and ML infrastructure, between defining technical strategy and writing the code that proves it out. The problems are genuinely hard, largely unsolved, and what you build will matter.

This is an opportunity for someone who wants to be a part of a small, fast moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

Own the technical architecture for our core systems and build the foundational abstractions and interfaces that everything else is built on top of
Build reliable integrations with dozens of external clinical data systems (EHRs, CTMS, eSource, labs), treating this as a hard systems design problem, not just an ingestion problem
Build and evolve the infrastructure that supports model training and predictive capabilities, from ingestion through feature engineering and serving
Move fast by prototyping to drive experimentation; derisk ideas quickly to keep the team building what works
Evaluate and choose the technologies we build on: make build vs. buy decisions, select vendors, and shape our long-term infrastructure strategy
Make the key technical tradeoffs between speed and durability, between generality and shipping
Work across product, clinical operations, and data science to make sure you're solving the right problems, not just the interesting ones
Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

Have 10+ years of software engineering experience, with significant time spent designing and building systems not just features
Experience with healthcare data systems (HL7, FHIR, EHR/EMR integrations) or other highly regulated data environments
Have 2+ years experience working in a high-growth startup environment
Have deep experience with system integration, particularly across unreliable or heterogeneous external data sources
Can think through and explain the full picture of a complex system while still being effective at the implementation level
Experience using AI tooling and frameworks as part of your engineering workflow
Have built data pipelines and infrastructure that support analytical or ML workloads in production
Strong across the backend stack (Python, SQL, cloud infrastructure) and can pick up new tools and systems quickly
Have built systems from early stages, making foundational decisions with incomplete information, not just extending established infrastructure
Naturally raise the quality of the engineering around you through code review, architecture guidance, and honest technical conversation

Preferred Qualifications

Experience building ML training infrastructure or feature platforms
Familiarity with clinical operations, systems, or life sciences data
SOC 2, HIPAA or similar compliance experience baked into engineering practice
A track record of building systems that had to work correctly under real operational constraints, scale and complexity

New York pay range

$200,000—$325,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Ready to apply?

Iterative Health

View all jobs →

Vice President, Finance

Flagship Pioneering, Inc. · Cambridge, MA USA

Apply now

Accounting & Finance Quotient Therapeutics, Inc. Posted Apr 24, 2026

Quotient is seeking a hands-on, highly experienced Vice President of Finance who has experience working in a private biotech company with both pre-clinical and clinical programs. The ideal candidate will have strong finance expertise, experience with technical and operational accounting, proven experience as a leader, and a demonstrated ability to build innovative finance teams and systems. This individual must be comfortable working independently in a resource-constrained environment while building out the finance function and also providing strategic financial guidance to the executive team.

The Vice President of Finance will be responsible for overseeing all aspects of accounting, financial operations, and compliance while contributing meaningfully to corporate strategy and long-term planning. This is a key leadership role within the company and is the primary steward of financial strategy, discipline, systems, and governance.

Responsibilities:

Initially serve as the company’s controller, overseeing all accounting operations, financial reporting, and internal controls; ensure compliance with GAAP and all applicable regulations, manage monthly, quarterly and annual close processes as well as tax and regulatory filings, and initiate/lead financial statement audits
Partner with the CFO and leadership team to develop and refine the company’s financial strategy and long term operating plan; provide scenario modeling, budgets, forecasts, long range planning models and capital allocation recommendations, and support fundraising activities, investor relations and board-level financial reporting
Implement and maintain innovative and scalable accounting and financial systems, processes and tools; oversee cash flow management, including tracking of R&D expenses, collaboration budgets and operational spend, and lead implementation of accounting and finance systems independent from the Flagship ecosystem
Plan and build out a small internal finance team, fostering growth and accountability; develop and oversee launch of finance function independent of Flagship support, oversee and coordinate work of external vendors, including auditors, accounting consultants, tax advisors and payroll providers, ensuring vendors meet performance expectations, budgets and timelines

Qualifications:

Essential

15+ years of progressive finance and accounting experience, including senior leadership roles
Proven track record in a private life sciences/biotech company with both clinical and pre-clinical programs
Strong understanding of GAAP and biotech-specific accounting issues, including R&D accruals and clinical trial accounting
Experience leading budgeting, financial reporting and long range planning processes
Experience building teams and system transitions/implementations
Experience managing direct reports and external vendors
Demonstrated ability to work independently in a fast-paced, entrepreneurial environment

Desirable

CPA or MBA strongly preferred
Experience supporting fundraising activities (venture capital, crossover, IPO readiness)
Understanding of and interest in utilizing AI and automation for finance
Familiarity with biopharma collaboration accounting and reporting as well as cost modeling for clinical development and pre-clinical programs

Values and Behaviors:

Encourage respectful disagreement and cultivate open-minded, ego-free interactions to continuously push each other towards excellence
Seek out diverse perspectives; practice active listening and genuine curiosity to ensure all contributions are valued, regardless of source
Recognize the impact of your behavior, language and attitudes, and strive for balanced, meaningful exchanges that enhance mutual growth and understanding in all interactions
Use a company-first mindset to guide decision-making; prioritize team over individual success
Take calculated risks and challenge convention in the quest for exceptional outcomes

About Quotient:

Quotient Therapeutics is a privately-held, early stage company developing breakthrough medicines informed by natural somatic genetic diversity present in patients. Through our work in somatic genomics, we are forging a new status quo for biopharma research and development across a broad pipeline of internal and partnered programs.

The company was founded by Flagship Pioneering, an innovative enterprise that conceives, creates, resources, and grows first-in-category life sciences companies. Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Generate Biomedicines, Sana Biotechnology (SANA), Tessera Therapeutics, Evelo Biosciences (EVLO), Indigo Agriculture, Seres Therapeutics (MCRB), and Syros Pharmaceuticals (SYRS).

Quotient Therapeutics and Flagship Pioneering are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies:

Quotient Therapeutics (“Quotient”) and Flagship Pioneering (“FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Quotient, FSP or their employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $250,000 - $350,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Quotient Therapeutics, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Quotient Therapeutics, Inc.'s good faith estimate as of the date of publication and may be modified in the future.

Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.

Ready to apply?

Apply to Flagship Pioneering, Inc.

Flagship Pioneering, Inc.

View all jobs →

Associate Director, Data Management

Obsidian Therapeutics · Cambridge or Bedford, MA

Apply now

Clinical Operations Bedford, MA Cambridge, MA Posted Apr 17, 2026

About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We are looking for a highly motivated Associate Director of Data Management. As a key contributor within the Clinical Operations team, you’ll be responsible for leading the entire data lifecycle at the program level for development of our first clinical stage autologous cell therapy program targeting solid tumors.

You will be responsible from study startup to database lock for multiple clinical studies developing engineered TIL cell therapies for certain solid tumor indications, oversee end-to-end clinical data strategy, ensuring high-quality, regulatory-compliant data (e.g., SDTM/CDISC) from study startup to lock.

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

This is a Hybrid role based out of Bedford or Cambridge, MA locations.

You Will...

Core responsibilities

Manage all clinical data management (CDM) activities, serving as the primary point of contact for CROs and vendors, ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP
Actively represent Data Management in study team meetings, leadership forums, and regulatory audits
Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data
Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners
Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions
Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)
Collaborate with Programming to implement internal data quality checks and support ongoing data review activities
Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries
Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy
Manage vendors and ensure appropriate resourcing to support clinical trial execution
Coordinate CDM deliverables across internal and external cross-functional teams
Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data
Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement
Develop and refine standard operating procedures (SOPs)
Apply strong project management, organizational, and interpersonal skills to support successful study execution
Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes
Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.  
Flexible - adapts to change in a fast paced, rapidly developing environment
Curious and humble – seeks and welcomes input/expertise of others, continuous learner
Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments

You Bring...

Core Qualifications

Education: Bachelor's Degree in life sciences, mathematics, or related field; with 10+ years of progressive experience in a biopharma setting, or a master's degree with 8+ (Master’s preferred).
Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy.
Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave.
Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations.
Leadership: Proven ability to manage CROs and lead cross-functional teams.
Excellent planning, coordination, and time management skills 
Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership. 
Ability to build and maintain productive relationships with colleagues within the clinical team, across the Obsidian organization, and with external partners.

Obsidian is committed to equitable and transparent pay practices.

The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.

Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.

Anticipated Base Salary Range

$183,000—$223,500 USD

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Ready to apply?

Apply to Obsidian Therapeutics

Obsidian Therapeutics

View all jobs →

Vice President, Biometry

Parabilis Medicines · Cambridge or Remote

Apply now

Development Cambridge Posted Apr 17, 2026

Why Join Us?

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and AR^ON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The Vice President of Biometry will lead Parabilis’s biometrics organization, overseeing biostatistics, statistical programming, data management, clinical data science and Real-World Data to support clinical development programs from early-phase through regulatory submission. This strategic role ensures the integrity, quality, and compliance of all clinical trial data and analyses while driving innovation in data strategy and statistical methodologies. Reporting to our SVP, Development Operations, the successful candidate will serve as a key member of the Development leadership team, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, translational/computational biology and other functions to enable data-driven decision-making and successful product development.

Lead and develop the Biometrics organization, including biostatistics, programming, data management Clinical Data science ensuring high-quality deliverables across all clinical programs and fostering a culture of scientific rigor, accountability, collaboration and innovation.
Oversee design and implementation of statistical methodologies for clinical trials.
Champion innovative methodologies, including adaptive and model-based approaches, to support efficient and agile drug development.
Provide strategic input into drug development strategies in collaboration with program-level and functional leadership, working closely with Clinical Development, Clinical Operations, and Translational Medicine.
Ensure the integrity, high quality and traceability of clinical trial data and the accuracy of all statistical analyses, leading to compliant deliverables in biometry.
Lead and support biometrics interactions with global health authorities.
Establish and maintain vendor partnerships ensuring quality and timely delivery of outsources biometrics activities.

What you’ll need to be successful:

Doctoral degree in Biostatistics or related field.
15+ years of biometrics experience within the biotech or pharmaceutical field.
Proven track record of leading, building, and managing teams.
Demonstrated record of fostering creativity, productivity, and execution with urgency, teamwork and accountability.
Company leader who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives.
Deep knowledge of clinical trial design, regulatory requirements, and statistical environment.
Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics.
Ideally, has worked in more than one therapeutic area and has direct experience with innovative Phase 1-3 clinical study designs for oncology.
Comfort with model-based drug development and agile drug development is important.
Appreciation for observational methodologies is preferred.
Ability to articulate complex methodologies to senior executives for their understanding is required with previous experience with presenting to senior executives being ideal.
Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus.

Core Values

Parabilis is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
In(ter)dependent.We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
Patient-focused.We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
All-In.We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary target for this position is $340,000-$380,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com

Ready to apply?

Parabilis Medicines

View all jobs →

PH

Alliance Manager, Strategic Accounts

PhaseV · One Broadway, 11th floor, Cambridge, MA 02142, USA

Apply now

Alliance Management Boston Office Posted Apr 14, 2026

PhaseV is a Boston-based technology company that redefines clinical development at scale with its enterprise-ready, multi-modal AI/ML platform — accelerating decisions, de-risking trials, and driving more efficient portfolio strategies. With over $65M raised from Accel, Insight, and others, we are poised to make a significant impact on how drugs are developed and brought to market.

Our tools span the entire pharmaceutical development process, from early program and portfolio decision-making through execution on registrational trials. From our Trial Optimizer platform which designs smarter clinical trials, to our ClinOps module, which enhances site selection by integrating patient-level insights, our offerings provide sponsors and CROs with a flexible, scalable toolkit for optimizing every stage of clinical development. We’re already collaborating with over 40 biopharma partners, including 7 of the top pharmaceutical companies, as well as multiple CROs and biotechs, with many more in late stage discussions.

The Role:

We are seeking a dynamic and experienced Alliance Manager in the US to lead our efforts in managing and expanding relationships with key clients. The Alliance Manager will play a critical role in defining engagement strategy, driving revenue growth, and ensuring client satisfaction, at assigned accounts.

Your Responsibilities:

Reporting to the Head of Alliance Management, this person will join the Alliance Management team and own strategy implementation at their assigned accounts.
Account Management & Growth:
- Develop and execute strategies to drive expansion, up-sell, cross-sell opportunities, and revenue growth within assigned accounts.
- Own the land-and-expand motion at assigned accounts, interfacing with Project Management, Business Development, and delivery teams to ensure that ongoing projects are successful and new opportunities are identified.
- Act as a trusted advisor to clients, developing and maintaining strong relationships with scientific and business stakeholders
Strategic Planning:
- Collaborate with the Head of Alliance Management and extended leadership team to build company strategy and roadmap.
- Establish lead generation strategies for each business line and identify necessary assets, materials, and resources to implement these strategies effectively.
Internal Collaboration & Operational Excellence:
- Work cross-functionally with product, project management, data science, customer success, and marketing teams to ensure seamless execution of projects at assigned accounts
- Track KPIs, including customer satisfaction, retention, and revenue growth.
Participate in externally-facing marketing, through attendance at conferences and events, solidifying PhaseV brand recognition within assigned accounts.
Develop an in-depth knowledge of company offerings to identify business opportunities. Gain an excellent understanding of the target market and ideal champions within biotech and pharmaceutical organizations.

Qualifications:

5+ years of experience in the biotech or pharmaceutical industry, with a strong focus on project or alliance management
Solid understanding of strategic account management i.e. expansion, renewals etc., with direct experience beneficial but not required.
Team player with a desire to drive innovation and have a positive impact on the industry.
Strong technical and analytical understanding. Experience with AI/ML solutions through previous roles is a plus.
Ability to clearly communicate with a wide range of stakeholders and translate scientific insights into actionable decisions.
Engaged listener, leverages input and a variety of perspectives to develop solutions

Desired Skills:

BS in a relevant field. MS, PhD, MD, or other relevant advanced degree a plus.
Background in biopharma, consulting or in similar roles at AI/ML vendors, with experience serving pharma clients.
Driven, self-motivated individual who is passionate about innovation in drug development.
Expertise in developing and delivering presentations for diverse stakeholders.

What We Offer:

Join us on a mission to change the world for the better.
The opportunity to work with an amazing team passionate about making a real-world impact.
Extremely hard and diverse problem setting, in which the team is pushing the envelope.
A collaborative and dynamic startup environment.
Professional growth and development opportunities.
Competitive compensation and equity participation
Comprehensive benefits, 401(k) match, and flexible hybrid culture

Ready to apply?

Apply to PhaseV

PH

PhaseV

View all jobs →

BE

Senior Director, Global HEOR

Beam Therapeutics · Cambridge, MA

Apply now

Medical Affairs Beam - Cambridge Posted Apr 10, 2026

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

Beam is seeking a dynamic, visionary, and strategic Senior Director, Global HEOR to spearhead the global HEOR strategy for our sickle cell disease program (risto-cel) and other pipeline programs as they emerge . In this high-impact role, the Senior Director, Global HEOR will develop and execute evidence-generation plans, manage stakeholder relationships, and shape external communication strategies. You will partner closely with Clinical Development, Medical Communications and Scientific Publications, Value and Evidence Strategy, Commercial, R&D, and additional cross-functional teams. If you thrive in a collaborative, mission-driven environment and are eager to shape the future of sickle cell disease care, we want you to bring your expertise and passion to Beam.

Responsibilities:

Provide strategic input to disease prioritization, target product profiles, clinical trial protocols, clinical development plans, and regulatory submissions; lead development of clinical sections for Investigator’s Brochures, briefing books, safety updates, IND/NDA materials, and responses to Health Authority questions.
Develop, validate, and integrate patient‑centered outcomes (PROs) into protocols and analyses.
Interpret clinical trial results (including PROs and healthcare resource use) and partner with Clinical Development/Biostatistics on Statistical Analysis Plans (SAPs) and post‑hoc analyses.
Lead a fit‑for‑purpose RWE strategy (EHR, claims, registries, hybrid/open datasets) including natural history/registry design and governance to inform endpoints, recruitment, and post‑authorization effectiveness/safety assessments.
Develop and operationalize external/synthetic control arm approaches (e.g., matched registry cohorts, Bayesian borrowing) for single‑arm or small‑population studies typical in cell & gene therapy.
Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies; contribute to long‑term capability building (digital health, real‑world studies).
Elicit and integrate perspectives from patients, KOLs, policy leaders, and internal stakeholders (market access, marketing, patient advocacy) to ensure plans meet the needs of patients, HCPs, and payers.
Support Market Access on internal and external payer/policy initiatives (pricing and reimbursement, unmet medical need, regional market dynamics, evidence gaps) across the portfolio.
Support business decisions around ex-US strategy including, but not limited to, scoping ex-US opportunities, prioritizing country engagement, early scientific advice / parallel consultations with EMA and HTA bodies (e.g., HTACG/JSC), providing advice to development programs on endpoint selection to support product and reimbursement approvals ex-US, etc.
Anticipate payer evidence needs and budget‑impact critiques (including preparation for ICER Reviews).
Build and maintain economic models (cost‑effectiveness, budget impact) tailored to one‑time CGTs, addressing uncertainty/durability and caregiver burden.
Collaborate with Market Access to design innovative payment models and outcomes‑based agreements with pragmatic outcomes and tracking.
Lead the AMCP dossier and pre‑approval information exchange (PIE) strategy (6–12 months pre‑launch).
Work collaboratively with internal teams, consultants, and CROs to advance development of the portfolio.

Qualifications:

Master’s Degree or higher in Health Economics and Outcomes Research or a relevant discipline.
Formal training in Epidemiology/Health Services Research required.
At least 10+ years’ experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm.
Proven track record in drug development, with rare disease experience and an existing network of hematologists preferred.
Demonstrated ability to lead in a matrixed, cross-functional environment, combining strategic agility with strong business acumen.
Independent, proactive operator with strong ownership.
Cross functional collaboration with Clinical, Regulatory, Commercial, Medical Operations, and Publications while maintaining medical/scientific integrity.
Excellent communication, collaboration, and problem-solving skills.
#LI-Hybrid

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range

$260,000—$320,000 USD

Ready to apply?

BE

Beam Therapeutics

View all jobs →

BE

Corporate Counsel/Senior Corporate Counsel, Commercial Contracts

Beam Therapeutics · Cambridge, MA

Apply now

Legal Beam - Cambridge Posted Apr 10, 2026

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

Beam Therapeutics is seeking a highly skilled attorney to serve as the Corporate Counsel/Senior Corporate Counsel, Commercial Contracts. This role will partner with Beam’s medical affairs, commercial and manufacturing teams to provide contracting support for Beam’s transition to a commercial stage company. Ideal candidates will excel in negotiating complex agreements, managing risk, and achieving business objectives in a fast-paced, cutting-edge biotechnology company.

Responsibilities:

Draft and negotiate high-stakes agreements in support of Beam’s anticipated product launches, including complex commercial contracts with gene therapy treatment centers, channel partners and manufacturers.
Assist with legal review of other pre-commercial activities, including advisory boards, patient engagement events, patient support programs, market access activities, speaker programs, and market research.
Provide legal support to Beam’s various promotional material review committees.
Provide ongoing contracting support and lifecycle management, including agreement interpretation and risk analysis, for Beam’s commercial, medical affairs, manufacturing and other teams.
Collaborate with business teams and subject matter experts on continuous review and updates of Beam contracting playbooks and standards.
Draft and negotiate a range of other key agreements in support of Beam’s broader business, including clinical trial agreements, material transfer agreements, sponsored research agreements, service provider agreements, and non-disclosure agreements.

Qualifications:

Juris Doctor (JD) from an accredited law school; admission to practice in at least one U.S. jurisdiction.
5+ years of experience with complex biotechnology contracting, ideally with commercial-stage cell and gene therapy companies.
Ability to manage multiple, overlapping, high-stakes agreements to completion on tight timelines.
Flexible, must be able to work collaboratively with team members for a diverse range of projects.
High degree of professional ethics and integrity.
Sound judgement and ability to quickly analyze different sources of information.
Practical and business-minded, capable of recognizing, assessing, and responding to urgent matters with timely, pragmatic, and clear solutions.
Exceptional and demonstrated written and verbal communication skills.
Candidates are expected to come onsite 2 days per week.

Additive Qualifications:

Experience advising medical affairs and commercial teams on legal and regulatory legal requirements related to product launches.
Ability to provide legal counsel on health care laws, such as anti-kickback, false claims and transparency statutes.
Service on promotional material review committees for pre-commercial or commercial biotechnology companies.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range

$210,000—$320,000 USD

Ready to apply?

BE

Beam Therapeutics

View all jobs →

Senior Clinical Scientist

Alkeus Pharmaceuticals · Cambridge, MA

Apply now

Clinical Development Cambridge, MA Posted Apr 9, 2026

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late-stage (Phase 3) clinical development programs in rare disease ophthalmology. This role plays a critical part in ensuring the scientific integrity, regulatory readiness, and successful execution of pivotal clinical trials intended to support global registration.

As a senior individual contributor, the Senior Clinical Scientist serves as a core scientific partner across clinical development, working closely with clinical operations, biostatistics, regulatory affairs, and safety to translate strategy into executable, high-quality Phase 3 studies. This role is well-suited for an experienced hire with demonstrated success in late-stage clinical development within rare disease and/or ophthalmology.

Primary Responsibilities:

Provide scientific leadership for Phase 3 clinical trials, including contributions to overall clinical development strategy, study design, endpoint selection, and patient population definition, with a focus on rare disease and ophthalmology indications.
Lead or co-lead the development of pivotal study protocols, informed consent forms, and key scientific sections of regulatory documents, ensuring alignment with global regulatory expectations (FDA, EMA, and other health authorities).
Serve as the scientific point of contact for assigned programs, providing ongoing oversight throughout trial execution, including review of emerging data, identification of scientific risks, and interpretation of results.
Partner closely with clinical operations to ensure Phase 3 trials are scientifically sound, operationally feasible, and executed in accordance with protocol, timelines, and quality standards.
Collaborate with biostatistics and data management to support statistical analysis plans, data review activities, interim analyses (as applicable), and final interpretation of clinical outcomes.
Contribute to and support regulatory interactions, including preparation of briefing documents, responses to information requests, and participation in meetings with health authorities as a scientific representative of the program.
Lead or significantly contribute to the preparation of clinical study reports, integrated summaries, investigator brochures, external presentations, scientific content for regulatory submissions, publications, author responses to questions from health authorities and other stakeholders.
Support safety monitoring activities, including review and interpretation of adverse events and safety data, participation in safety review meetings, and collaboration with pharmacovigilance to ensure appropriate benefit–risk assessment for late-stage programs.
Provide scientific input into investigator meetings, site feasibility and selection activities, and key study communications to ensure consistency and clarity across global trial sites.
Mentor junior clinical scientists and contribute to the development of best practices, processes, and standards appropriate for a Phase 3–stage organization.

Deliver on other related projects and initiatives as assigned, with flexibility to support evolving program needs in a growing biotechnology environment.

Qualifications:

Education and Certification
- Master’s or Ph.D. in a relevant scientific discipline required
Work Experience
- 6–10+ years of experience in pharmaceutical or biotechnology clinical development setting, experience in Ophthalmology a plus
- Demonstrated experience supporting or leading Phase 3 clinical trials, including protocol development, data interpretation, and clinical study reporting
- Prior experience in rare disease and/or ophthalmology drug development strongly preferred
- Experience supporting regulatory interactions and late-stage clinical submissions (e.g., NDA/BLA/MAA components) highly desirable
- Experience working in a cross-functional, matrixed environment typical of small to mid-sized biotech companies
Skills and Key Success Factors:
- Deep understanding of late-stage clinical development and the scientific and regulatory expectations for pivotal trials
- Strong scientific judgment with the ability to independently assess data, identify risks, and propose solutions
- Entrepreneurial mindset with comfort operating in a fast-paced, resource-conscious organization
- Highly organized and detail-oriented, with a strong commitment to data quality, accuracy, and compliance
- Excellent written and verbal communication skills, including the ability to clearly convey complex clinical data to internal and external stakeholders
- Collaborative leadership style with proven ability to influence across disciplines without direct authority
- Hands-on, proactive approach with a strong sense of accountability and urgency
- Highest standards of professionalism, integrity, and ethical conduct

Other Relevant Information:

Travel: Able to travel as assigned

Compensation

Base Salary Range: $160K - $240K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
Discretionary Bonus: 15% - 20% of Base Salary, contingent upon meeting performance components
Equity: initial grant of incentive stock options
Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.

Ready to apply?

Apply to Alkeus Pharmaceuticals

Alkeus Pharmaceuticals

View all jobs →

Associate Director, Clinical Data Programmer

Amylyx Pharmaceuticals · Cambridge, MA

Apply now

313 - Biometrics United States Posted Apr 9, 2026

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.

Responsibilities

Lead the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight.
Supports leading data management activities (i.e. DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases.
Performs UAT of systems and ensures appropriate plans and documentation are in place.
Leads the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review.
Manages external vendor compliance and quality checks.
Supports Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges.
Ensures databases adherences to SOPs, 21CRF Part 11, ICH-GCP and CDISC Standards (CDASH/SDTM)
Acts as a subject matter expert in leading technical initiatives and data management

Required Qualifications

Bachelor’s degree or higher in Life Science or related discipline
8+ years of experience in clinical data management
Extensive experience with clinical data systems (particularly Medidata Rave) and languages like SAS, R or Python
Proven experience in clinical trial programming and database management
Knowledge of Clinical Data Standards such as CDISC CDASH, and SDTM
Provide strong support to Data Management
Experience creating advanced interactive data visualizations from raw data using multi-languages and applications such as Using SAS, R, Python, RShiny, Power BI, Tableau, Spotfire etc.
Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Excellent written and verbal communication skills and organizational and documentation skills.

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote locatio

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$183,000—$206,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ready to apply?

Amylyx Pharmaceuticals

View all jobs →

Director, Pharmaceutical Development

Fulcrum Therapeutics · Cambridge, MA

Apply now

Cambridge, MA Posted Apr 9, 2026

Company Overview

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Pharmaceutical Development function.

Description

Reporting to the Head of Technical Operations, the Director of Pharmaceutical Development will lead all drug product development activities including technical, managerial, and budgetary aspects. This includes formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation. The successful candidate will lead, plan and manage the technical and business-related activities associated with drug product development and manufacturing at contract development and manufacturing vendors for all dosage form programs.

Key Responsibilities

Lead all strategic and tactical aspects of drug product development at Fulcrum
Design and execute pharmaceutical product development plans for all development programs in accordance with corporate goals
Collaborate with colleagues in Drug Substance, Analytical, ClinOps, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
Lead pharmaceutical development for the pociredir program, including CTM for pivotal clinical studies, pre-validation studies, validation plans, and commercial launch supply
Lead and manage product development, technology transfer, and clinical manufacturing activities at contract manufacturing organizations (CMOs), assuring compliance with Regulatory and Quality requirements
Lead pediatric formulation development efforts, as required
Review and approve a broad spectrum of documents (MBRs, Specifications, Protocols, Reports, etc.) at CMOs
Generate, review and approve documents related to Drug Product (formulation, process development, manufacturing, etc.) for Regulatory submissions (IND/IMPD and NDA/MAA)

Qualifications

D with 10 years or MS with equivalent years of experience. Professional background in Pharmaceutical Sciences (preferred) or Chemical Engineering
Proven track record and leadership in phase-appropriate drug development through pivotal studies (required) and approval (preferred)
SME in material science aspects of dosage forms and drug delivery, with emphasis on solid oral dosage forms; strong knowledge in Dissolution, Biopharmaceutics and PK
Well versed in Regulatory CMC and ICH guidance, including exposure to FDA interactions (e.g. via EOP2 or preNDA meetings)
Strong written and oral communication skills; highly effective collaborator with “customers” in ClinOps and Commercial
Ability to hire and recruit staff, including key contractors and consultants
Positive work presence; responds to stress and ambiguity with humor

Base Salary Pay Range

$240,000—$240,000 USD

Ready to apply?

Apply to Fulcrum Therapeutics

Fulcrum Therapeutics

View all jobs →

Clinical Trial Manager / Sr. Clinical Trial Manager

Alkeus Pharmaceuticals · Cambridge, MA

Apply now

Clinical Operations Cambridge, MA Posted Apr 8, 2026

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary

The Clinical Trial Manager (CTM) is responsible for the execution, and oversight of global clinical trials, ensuring high-quality delivery in alignment with ICH-GCP, regulatory requirements, and corporate objectives. This role provides day-to-day operational management of CROs and vendors and contributes to the development of processes that support the growth of the Clinical Operations function. This position requires on site presence in the Alkeus office in Cambridge, MA.

Responsibilities

Manage daily clinical trial operations for a global clinical trial across all trial phases (startup through closeout), ensuring adherence to timelines, budget, and quality standards.
Coordinate cross-functional team activities, document review.
Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
Provide monitoring oversight, including participation in co-monitoring visits, reviewing monitoring reports, confirming follow-up on action items and escalating issues.
Support start-up activities to help accelerate site activations
Oversee site management and site engagement initiatives to maintain strong site relationships.
Lead study-specific meetings, including internal team meetings, CRO/vendor meetings.
Provide input on key study documents including protocols, ICFs, eCRFs, and operational plans, etc.
Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
Support risk identification and mitigation planning efforts.
Maintain inspection readiness and ensure compliance with SOPs and regulatory standards.
Prepare regular study updates, presentations, and risk assessments for senior leadership.
Contribute to process improvement initiatives, development of SOPs, and operational best practices for the Clinical Operations department.

Qualifications

Bachelor’s degree in a scientific or health-related field required; Advanced degree preferred.
Minimum 5 years managing clinical trials and 8+ years of industry experience.
Experience managing outsourced global clinical trials across Phase I–III strongly preferred.
Experience managing phase III trials is a must.
Strong knowledge of ICH-GCP and global regulatory requirements.
Experience in biotech/pharma environment required.
Ability to manage multiple tasks in a fast-paced environment.

Skills and Key Success Factors:
- Entrepreneurship spirit with a passion to build, learn and evolve with the team
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

Travel: As required

Compensation

Base Salary Range: $140,000 - $160,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
Discretionary Bonus: up to 15% of Base Salary, contingent upon meeting performance components
Equity: initial grant of incentive stock options
Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.

Ready to apply?

Apply to Alkeus Pharmaceuticals

Alkeus Pharmaceuticals

View all jobs →

Associate Director, Data Science, Computational Biology

Parabilis Medicines · Cambridge, MA

Apply now

Data Science & Engineering Cambridge Posted Apr 6, 2026

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs.

What’s the opportunity?

This role is the primary computational partner for one or more pipeline programs, working across both preclinical and clinical spaces to convert complex biomarker, mechanistic, and RWD/E datasets into clear, actionable insights for target, dose, indication, and combination strategy. Reporting to the Head of Computational Biology, a successful candidate will design and implement robust analysis workflows spanning in vitro and in vivo studies, early‑phase trials, and external data sources to refine patient selection and mechanism‑of‑action understanding. The ideal candidate will couple their prior experience in oncology with a deep understanding of bioinformatics methodologies, a strong computational skill set, and an ability to translate scientific challenges into technical solutions and analysis that informs team decisions.

Scope of the role:

Strategic thinker, planner and implementer of computational biomarker and translational analyses for early‑phase oncology studies (e.g., FOG‑001 and ERG/AR degraders), from IND‑enabling work through Phase 1/2, ensuring continuity between preclinical and clinical datasets.
Design and execute analysis plans for diverse biomarker modalities across preclinical models and clinical samples, including bulk and single‑cell RNA‑seq, DNA panels/WES, ctDNA, IHC/IF, multiplex protein assays, and other exploratory readouts.
Synthesize, summarize and communicate findings in a clear, decision‑oriented manner to cross‑functional teams and governance, and contribute to internal decision making, conference abstracts, and manuscripts as appropriate.

Who you’ll be working with:

Partner closely with discovery biology, translational scientists, clinicians, biostatistics, and RWD/E colleagues to define questions that leverage both preclinical and human data, and to design analyses that are statistically and biologically robust

Main tasks & duties for the position:

Analyze preclinical in vitro and in vivo data (e.g., Helicon screens, xenograft/PDX models, pharmacology and PD studies) to characterize target engagement, pathway modulation, and resistance mechanisms, and translate these findings into clinical hypotheses.
Analyze pre and on treatment patient biopsies and blood samples to quantify pathway modulation, signaling changes, and emergent resistance or sensitivity signatures, integrating with preclinical findings where possible.
Develop, validate, and operationalize predictive and pharmacodynamic biomarker signatures for use in preclinical strategy, trial design, and RWD/E anchored analyses, including patient stratification and indication/expansion cohort selection
Uses leading-edge knowledge of principles, concepts and practices and/or techniques to lead complex projects involving related departments; May have supervisory responsibilities

What you’ll need to be successful:

PhD in Computational Biology, Bioinformatics, Statistics, Epidemiology, or related field, or MS with significant industry experience in translational, clinical biomarker, and/or RWD/E analysis in oncology.
7+ years of relevant post graduate experience (biotech/pharma or closely related), including direct work with both preclinical and clinical oncology datasets.
Strong hands on experience analyzing biomarker data such as DNA sequencing, RNA seq (bulk and/or single cell), ctDNA, and tissue based assays (IHC/IF, multiplex platforms), with demonstrated impact on either discovery or development decisions, ideally both.
Proficiency in Python and/or R, including data wrangling, statistical modeling, visualization, and best practices for reproducible research (version control, environments, documentation).
Comfortable operating at the interface of discovery, translation, clinical development, and external data, with a track record of effective collaboration with non-computational colleagues.
Excellent communication skills, with the ability to translate complex analyses into concise, decision ready narratives for diverse audiences.
Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovative use of AI is a strong plus.
Able to work on-site and attend in-person meetings for the majority of time.

Core Values

Parabilis is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
In(ter)dependent.We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
Patient-focused.We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
All-In.We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary target for this position is $175,000 - $220,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Ready to apply?

Parabilis Medicines

View all jobs →

Senior Manager, Clinical Operations

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Clinical Operations Cambridge, MA Remote Posted Apr 6, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Associate Director, Clinical Operations, the Sr. Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. You will be working on a clinical study with responsibilities including site selection, contract negotiation, budget management, study start-up, conduct and close-out. This role will collaborate with cross-functional study team as well as demonstrate excellent management of and partnership with CROs and vendors. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results.

Responsibilities:

Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. Collaborate with cross-functional clinical study team to support clinical study delivery.
Evaluates, and ensures appropriate oversight of CROs and other external vendors.
Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals.
Identify risks and propose solutions to facilitate clinical studies.
Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to budget forecasting and accruals in collaboration with finance.
Oversee and manage the creation, maintenance, QC and close out of TMF activities.
Ensure appropriate oversight of enrollment, site activation and data collection milestones.
Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
Collaborate with Data Management to ensure timely and efficient database lock. Participate in data review and reconciliation efforts.
Lead or co-lead department initiatives to support an expanding organization.
Travel may be required (10% – 15%).

Competencies Include:

Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
Excellent problem solving, communication and organization skills.
Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
Ability to work in a collaborative environment and build effective working relationships across the organization.
Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously.

Qualifications:

At least 5 - 7 years of Clinical Operations experience.
Bachelor’s degree or higher in a scientific or healthcare discipline preferred and relevant experience within the biotech, pharmaceutical, or CRO industry.
Extensive knowledge of current ICH-GCP guidelines.
Relevant experience managing early through late Phase clinical trials.
Demonstrated cross-functional leadership fostering team spirit and team motivation.
Capability to challenge status-quo using risk management approach.
Able to thrive in a remote/virtual environment.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

Annual Salary Range

$145,000—$175,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

Associate Director/Director, Scientific Communications

Cognito Therapeutics · Cambridge, Massachusetts, United States

Apply now

Clinical Cambridge Office Posted Apr 3, 2026

Associate Director/Director, Scientific Communications, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

The Associate Director/Director, Scientific Communications will play a pivotal role in shaping and executing an integrated scientific communications strategy to support Cognito’s pipeline and future commercialization efforts. Reporting to the Head of Medical Affairs, this individual will be a key member of the Medical Affairs team, responsible for leading medical education initiatives, publication strategy, and support of the Brain Health Collaboratories.

This role is central to translating complex preclinical, clinical, and real-world data into clear, accurate, and compliant communications for both internal and external stakeholders, including healthcare professionals, payers, and scientific communities. The Director will ensure timely and effective dissemination of scientific data while aligning communications with congress activities and subject matter expert (SME) engagement strategies.

The position may be remote or hybrid (Cambridge, MA) and requires both strategic leadership and hands-on execution in a fast-paced, innovative environment.

Roles and Responsibilities

Strategic Leadership & Planning

Develop and execute an integrated scientific and medical communications strategy aligned with corporate objectives and evolving standards of care.
Define and lead publication planning, including identification of key data milestones, communication opportunities, and stakeholder alignment.
Ensure seamless integration of communication plans with congress strategy and SME/KOL development.

Scientific Communications & Content Development

Translate complex scientific and clinical data into clear, compelling, and compliant communications for diverse audiences.
Lead the development of medical communication materials, including:

Abstracts, posters, manuscripts, and presentations
Unbranded disease state education materials (e.g., slide decks, training tools)

Support data dissemination across multiple platforms and audiences.

Omnichannel Execution

Implement omnichannel communication strategies to ensure consistent, effective delivery across digital, print, and live channels.
Support and participate in scientific congresses, including presentation of data as appropriate.

Cross-Functional Collaboration & Stakeholder Engagement

Serve as a central point of contact for scientific communications, coordinating with internal teams, external partners, and publication authors.
Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and professional societies, particularly in Alzheimer’s disease and related neurodegenerative disorders.
Support advisory boards, roundtables, and scientific exchange initiatives to capture external insights and inform strategy.

Training & Internal Enablement

Develop and deliver medical and scientific training for internal stakeholders, including commercial, clinical, and cross-functional teams.
Ensure alignment and scientific rigor across all internal education initiatives.

Governance, Compliance & Operations

Lead Medical (MLR) review processes, along with Legal, and Regulatory partners to ensure all materials meet compliance and scientific accuracy standards.
Manage external vendors and agency partners supporting medical communications.
Ensure adherence to regulatory, ethical, and company standards across all activities.

Qualifications & Experience

Advanced degree in a relevant scientific or clinical discipline (MD, PhD, PharmD, or equivalent) preferred.
5+ years of experience in Scientific or Medical Communications within biotech, biopharma, or medical device industries; experience in neuroscience or neurodegeneration strongly preferred.
Demonstrated ability to translate complex scientific data into clear, impactful narratives.
Proven success in KOL engagement, publication strategy, and medical communications execution.
Experience collaborating across functions and managing external partners, including academic institutions and vendors.
Strong leadership, communication, and organizational skills; ability to thrive in a fast-paced, matrixed, and entrepreneurial environment.
Willingness to travel (~15–20%) for scientific congresses and internal meetings.

Ready to apply?

Apply to Cognito Therapeutics

Cognito Therapeutics

View all jobs →

BE

Clinical Trial Manager

Beam Therapeutics · Cambridge, MA

Apply now

Clinical Operations Beam - Cambridge Posted Mar 30, 2026

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this role, you will serve as the operational lead - driving timelines, fostering collaboration, and ensuring the successful execution of clinical trials. The CTM will oversee day-to-day activities throughout the clinical trial lifecycle. Key responsibilities include managing start-up, conduct, and close-out activities in alignment with industry and corporate standards within ICH/GCP Guidelines.

Responsibilities:

Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities.
Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals.
Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO to manage the daily operational management activities of CROs and study vendors.
Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities.
Contribute to (or oversee the management of) the creation of the trial plans and site facing documents.
Develop (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members.
Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate.
Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study.
Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial.

Qualifications:

Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials.
Phase I experience is strongly preferred; a background in rare disease and/or metabolic disorders is highly desirable, and experience with cell & gene therapy is a plus.
Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes.
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
Ability and willingness to travel up to 20% (domestic and international).
#LI-Hybrid

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range

$130,000—$160,000 USD

Ready to apply?

BE

Beam Therapeutics

View all jobs →

Senior Medical Director, Clinical Development

Amylyx Pharmaceuticals · Cambridge, MA - Remote

Apply now

311 - Clinical Development United States Posted Mar 27, 2026

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio.

Reporting to the Senior VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives.

The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity.

In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.

Responsibilities

Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
Identifies and implements process improvements and best practices within Clinical Development.

Required Qualifications

MD required
Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred
Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution
Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
Strong strategic thinking, problem-solving, and decision-making skills
Proven ability to interpret complex clinical data and translate insights into actionable strategies
Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts
Experience mentoring or leading team members preferred
Ability to travel internationally and domestically

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$315,000—$354,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ready to apply?

Amylyx Pharmaceuticals

View all jobs →

Senior Director, Clinical Pharmacology

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Translational Development Cambridge, MA Remote Posted Mar 24, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

The Senior Director, Clinical Pharmacology will lead Nuvalent’s clinical pharmacology strategy across all development programs, including late‑stage registrational efforts and emerging early‑phase assets. This leader will guide dose optimization, exposure–response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions.

Responsibilities:

Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post‑marketing studies, including designing and leading clinical pharmacology studies.
Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations.
Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDA submissions.
Represent clinical pharmacology in interactions with FDA and other global regulators, supporting discussions related to dose justification, pediatric waivers, safety margins, and DDI strategies.
Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs to ensure cohesive end‑to‑end development plans.
Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety.
Guide quantitative pharmacology approaches supporting optimal dosing in patients.
Build and mentor a growing clinical pharmacology function as Nuvalent transitions from clinical‑stage to commercial‑
Contribute to portfolio prioritization, scenario planning, and long‑range clinical development strategy.

Competencies:

Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
Able to work independently, take initiative, and adapt quickly to evolving priorities.
Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
Ability to effectively manage multiple projects with competing priorities.

Qualifications:

D., Pharm.D., or M.D. with specialization in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
12+ years of experience in clinical pharmacology within biopharma, including leadership in oncology or small‑molecule drug development.
Proven track record supporting registrational‑stage programs and authoring components of regulatory submissions (INDs, NDAs/MAAs).
Prior work with kinase inhibitors, and oncology therapies strongly preferred.
Familiarity with late‑phase trial design and commercial launch preparation.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more

Annual Salary Range

$270,000—$295,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?

Nuvalent, Inc.

View all jobs →

Associate Director, Statistical Programming

Nuvalent, Inc. · Cambridge, MA / Remote

Apply now

Biostatistics & Programming Cambridge, MA Remote Posted Mar 17, 2026

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.

This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.

Responsibilities:

Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
Partner with or oversee CROs or Programming vendors to perform the tasks described above.
Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).

Competencies Include:

Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

Qualifications:

Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field.
8+ years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO).
Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures.
Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards.
In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards.
Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
Advanced understanding of statistical concepts in support of clinical data analysis.
Advanced knowledge of programming standards and processes.
Oncology experience is required.
Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers.

Annual Salary Range

$180,000—$210,000 USD

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.

Ready to apply?