Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

We are seeking a Central Operations Head (COH) to provide strategic leadership across clinical drug supply, Clinical Trial Agreement (CTA), and eTMF management to support global clinical development programs. This role partners cross-functionally with Clinical, Regulatory, Legal, Technical Operations, and Operational Excellence to ensure alignment on trial needs, risk management, and execution priorities.

You will oversee end-to-end delivery across trials, define outsourcing and vendor strategies, and ensure performance through KPIs, KRIs, and governance. This role is accountable for driving operational excellence, ensuring inspection readiness, and maintaining compliance with global regulations and internal standards.

As a leader, you will build and develop a high-performing team, establish scalable processes and best practices, and foster a culture of accountability, innovation, and continuous improvement in a fast-paced biotech environment.

Your role

• Provide strategic direction for clinical drug supply management, clinical trial agreement (CTA) management, and eTMF management activities to support clinical development objectives across all programs and trials
• Collaborate with Trial Management, Regulatory Affairs, Clinical Development, Legal, and Technical Operations to align on trial needs and deliverables
• Collaborate with Operational Excellence & Clinical Compliance and GMP compliance to align on risk assessment, metrics, KPIs, and KRIs for management of clinical drug supply, CTAs, and eTMF
• Define and implement outsourcing strategies (incl. Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs) and vendors) in partnership with VP of Global Clinical Operations and Head of Clinical Sourcing & Contracting
• Define functional goals, performance metrics, and resourcing strategies. Drive innovation including adoption of risk-based approaches
• Oversee end-to-end execution of drug supply-/ CTA-/ and eTMF management across clinical trials, ensuring timely, high-quality, and inspection-ready deliverables
• Track CRO, CMO, and vendor performance using metrics, KPIs, and KRIs; lead SMO governance meetings to address escalated issues and drive continuous improvement
• Establish and maintain best practices and standards throughout the trial lifecycle
• Ensure adherence to global regulatory requirements, GCP and internal SOPs. Lead audit and inspection readiness for drug supply-/ CTA-/ and eTMF management and implement effective oversight models for internal teams and outsourced partners. Perform internal quality reviews and ensure inspection readiness of trial documentation
• Lead, coach, and develop a high-performing team. Foster a culture of collaboration, continuous learning, and accountability, while supporting career progression and succession planning across the function
• Select, manage, and govern external vendors. Define expectations, monitor performance via KPIs, and drive accountability through governance forums to ensure quality, timelines, and cost-effectiveness

What You Bring

• 12+ years of trial management experience with 5+ years in leadership position
• Bachelor’s degree in Life Sciences, Pharmacy or related field (required). Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred)
• Significant experience working in global clinical development organization
• Significant experience in outsourcing and oversight
• Expert knowledge in ICH GCP and GMP
• Expert knowledge in computer technologies to plan, forecast, and track documents/ material on all levels
• Expert knowledge in risk assessment and management on program and trial-level
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, IRT) and operational metrics, KPIs, and KRIs
• Familiarity with clinical supply planning, forecasting, and inventory tools
• Independent judgment and objectivity
• Strong analytical and influencing skills
• Ability to drive accountability across functions
• Strong leadership and interpersonal skills

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

We are seeking a Site Management Leader (SML) to oversee all site management and monitoring activities conducted by the CRO in a clinical trial. This role will be assigned to critical clinical trials of the Tango portfolio and serve as the primary contact between sponsor and CRO for site management aspects.

In a fast-paced, small biotech environment, the SML will operationally oversee and manage the end-to-end site management activities as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your role

• Serve as the primary liaison between CTT and CRO for all site management activities
• Oversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standards
• Lead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTT
• Contribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspects
• Identify trial-level risks and contribute to the development and implementation of risk management and mitigation strategies
• Manage and monitor site identification, feasibility assessments, and site selection processes
• Ensure site readiness for initiation, including training, documentation, and logistical preparedness
• Oversee and support site initiation visits (SIVs) and ensure timely site activation
• Monitor patient recruitment strategies and enrollment progress across clinical sites
• Ensure protocol compliance and data integrity through oversight of site monitoring activities
• Review monitoring visit reports and ensure timely resolution of site issues and follow-up actions
• Collaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as needed
• Ensure adherence to ICH GCP, regulatory requirements, and internal SOPs throughout trial conduct
• Participate in audits, inspections, and quality assurance activities related to site management
• Oversee site closure activities and ensure proper documentation and archiving

What You Bring

• 5+ years of trial management experience with 3+ years in site management. Leadership experience (preferred)
• Bachelor’s degree in Life Sciences, Pharmacy or related field
• Experience working in global clinical development organization
• Experience in Oncology development (preferred)
• Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
• Knowledge of trial/ site risk assessment and management
• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
• Experience in outsourcing and oversight
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs
• Strong vendor management and project management skills
• Leadership skills with the ability to lead cross-functional teams
• Strong interpersonal and communication skills
• Strong analytical thinking and decision-making capabilities
• Willingness to travel, as required (typically 10 – 20%)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

In this new role, reporting to the Vice President, Biometrics you will be working with cross‑functional clinical teams responsible for statistical activities across Tango’s clinical programs, including overseeing statistical deliverables outsourced to clinical CROs. This is an exciting opportunity to make an impact in the development of transformative therapies that may change patients’ lives. You will be a good communicator, collaborative, self-motivated, and forward‑thinking.

Your Role:

• You will serve as a biostatistics expert for Tango’s clinical programs
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables
• Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
• Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
• Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
• Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
• Provide statistical input for clinical documents
• Perform QC/QA of statistical deliverables including validation of key analysis results
• Perform ad hoc statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
• Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
• Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations
• Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
• Represent Tango regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
• Support inspection readiness activities as needed
• Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
• Additional duties and responsibilities as required

What You Bring:

• PhD in statistics or related discipline; MS with appropriate years of directly relevant experience
• At least 10 years’ experience in the pharmaceutical or biotech industry
• Oncology experience required
• Experience in the design, analysis, and reporting of clinical trials
• Experience in INDs, NDAs, MAAs, or other regulatory submissions
• In-depth knowledge of statistical methods for clinical trials
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• Proficient in statistical programming (SAS and R)
• Ability to lead statistical efforts for multiple studies
• Fluent in data standards, including SDTM and ADaM
• Experience in outsourced statistical services provided by CROs
• Ability to work independently and act with initiative to address issues
• Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner

#LI-hybrid

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

About Avalyn

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Position Overview

The Associate Director of SEC Reporting & Technical Accounting will build and lead Avalyn’s external reporting and SOX compliance capabilities as a newly public biotechnology company. This high-impact, foundational position is ideal for a technically strong, pragmatic leader who enjoys creating structure in a dynamic, mission-driven environment. The Director will establish scalable SEC reporting processes, design and document internal controls over financial reporting, and serve as the Company’s subject matter expert on complex accounting matters. Reporting to the VP of Finance, this role partners closely with Finance and cross-functional teams across the organization to drive alignment, accountability, and best practices through strong collaboration and clear communication.

SEC Reporting

• Lead the preparation and timely filing of SEC reports, including Forms 10-K, 10-Q, 8-K, and S-8, and oversee XBRL tagging and related external reporting processes.
• Own the preparation and review of financial statements, footnotes, and MD&A, ensuring compliance with U.S. GAAP and SEC regulations.
• Partner with Legal, FP&A, Investor Relations, and senior leadership on earnings releases, proxy materials, and other public disclosures.

Technical Accounting

• Serve as the company’s subject matter expert on technical accounting matters, including revenue recognition, collaboration and licensing arrangements, R&D activities, financing transactions, and stock-based compensation under ASC 718.
• Research, evaluate, and document accounting conclusions for complex transactions and prepare technical accounting memoranda and policy documentation.
• Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.

SOX Compliance & Internal Controls

• Design and implement internal controls over financial reporting as the company continues to build toward full SOX compliance.
• Lead walkthroughs, risk assessments, control documentation, and remediation efforts in partnership with process owners and external consultants.
• Strengthen scalable controls and operating processes across SEC reporting, technical accounting, and equity administration.

Equity Accounting & Administration

• Lead equity accounting, including the calculation and recording of stock-based compensation in accordance with ASC 718.
• Oversee external support for day-to-day stock administration activities and help ensure strong governance around equity-related processes.
• Support Section 16 reporting and related compliance requirements in coordination with legal counsel.

External Audits

• Manage quarterly reviews and annual audits and serve as the primary liaison with external auditors on technical accounting matters.
• Coordinate PBC requests and support an efficient, well-organized audit process.

Qualifications

• A minimum of a Bachelor’s degree in Accounting or Finance required; CPA required.
• 8-10+ years of progressive accounting experience, including substantial SEC reporting and technical accounting experience in a public company environment.
• Big 4 or national public accounting firm experience strongly preferred.
• Demonstrated experience building or enhancing SOX compliance programs.
• Experience in biotechnology, life sciences, or other R&D-intensive industries strongly preferred; experience with cell therapy revenue recognition is a plus.
• Deep knowledge of U.S. GAAP and SEC regulations, including revenue recognition, equity compensation, and complex transaction accounting.
• Experience with tools such as Active Disclosure, Equity Edge, NetSuite, or similar systems preferred.
• Strong communication, sound judgment, and the ability to lead through influence in a fast-paced, mission-driven environment.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

About the Role

We are seeking a Clinical Trial Manager (CTM) to lead operational aspects of a clinical trial and support the Clinical Trial Leader (CTL), as required. This role will serve as a key member of the Clinical Trial Team (CTT) and as the primary contact for external parties and vendors. CTM may lead the cross-functional CTT for smaller and less complex trials or manage critical aspects of larger and more complex clinical trials under CTL leadership. In addition, CTM will be responsible for site management oversight for trials where no Site Management Leader (SML) is assigned.

In a fast-paced, small biotech environment, the CTM will operationally manage the set-up, conduct and reporting of clinical trials (or parts thereof) as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Key Responsibilities

• Serve as a core member of the Clinical Trial Team (CTT) and act as deputy for the Clinical Trial Leader (CTL) during absences
• Organize and coordinate CTT meetings, including preparing agendas, recording minutes, and tracking follow-up actions
• Facilitate communication and collaboration within the team and with external partners such as Contract Research Organizations (CROs) and vendors
• Contribute to the development and maintenance of trial-level documents and operational plans, including project management, communication, risk management, and quality plans
• Establish and manage trial-related systems and processes (e.g., central laboratories, eCOA/ ePRO) in alignment with protocol requirements
• Monitor CRO/ vendor performance and ensure timely and accurate data integration, transfer, and reconciliation. Escalate issues to the CTL, as needed
• Identify risks and issues and support the development and implementation of mitigation strategies and action plans
• Maintain accurate and up-to-date trial information in systems and communication tools
• Set up and maintain clinical trial insurance in participating countries
• Coordinate with the global supply chain to ensure timely supply and distribution of devices and investigational medicinal products, comparator or co-medication to clinical sites
• Prepare and distribute trial-related correspondence and contribute to the development of materials for meetings, newsletters, and websites
• Lead logistical arrangements and support content development for external meetings such as investigator meetings and advisory boards
• Ensure ongoing inspection and audit readiness. Participate in internal audits and regulatory inspections, as required
• Support budget forecasting and accrual processes. Assist with invoice tracking, and processing in line with vendor contracts
• Act as CTL when assigned, leading cross-functional CTT to operationalize the protocol of a clinical trial
• Lead the development of site management oversight plan and ensure site management oversight including risk management for trials without assigned Site Management Lead (SML)

What you bring: 

• 5+ years of trial management experience. Leadership experience (preferred)
• Bachelor’s degree in Life Sciences, Pharmacy or related field
• Experience working in global clinical development organization
• Experience in Oncology development (preferred)
• Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
• Experience in outsourcing and oversight
• Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
• Knowledge of financial planning, tracking, and reporting
• Knowledge of trial risk assessment and management
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and site management metrics, KPIs, and KRIs
• Strong vendor management and project management skills
• Leadership skills with the ability to lead cross-functional teams
• Strong interpersonal and communication skills
• Strong analytical thinking and decision-making capabilities
• Willingness to travel, as required (typically 10–20%)

#LI-HYBRID

#LI-HYBRI

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-HYBRID

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and innovative candidate for the role of Scientist / Senior Scientist of Analytical Development. The expectation is that the Scientist / Senior Scientist will have experience independently executing analytical experiments using HPLC/UPLC techniques. Reporting to the Associate Director of Analytical Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a desire to conquer new challenges.

Primary Responsibilities:

• Leads development, execution, and validation of RP-IP/RP/IEX based analytical methods to establish identity, purity, potency, and stability criteria for early-stage mRNA and LNP formulations using UPLC-ESI-ToF, PDA, and CAD.
• Analyzes data and draws conclusions which drive screening, optimization, and scale-up efforts in mRNA and LNP Process Development.
• Serves as subject matter expert in analytical chemistry, mass spectrometry, and method qualification and transfer.
• Interfaces with external contract research organizations to ensure compliance with internal timeline and quality requirements.
• Mentors and develops junior scientists in analytical theory and in applications of analytical technology and software platforms.
• Created proprietary ToF mass spec oligonucleotide mass target and predictive sequence library software to rapidly profile known and identify unknown oligonucleotide mass signals.
• Maintains electronic notebook records and authors protocols.
• Contributes to data packages for regulatory submissions.
• Actively maintains current understanding of RNA and LNP landscape by attending conferences and other events.

Qualifications:

• B.S. or Advanced Degree in Chemistry, Chemical Engineering, Biology, Biochemistry, Molecular Biology or other relevant scientific discipline.
• 7+ years of experience with a focus on varying liquid chromatography modes (RP, RP-IP, AEX, SEC, etc), LC-MS, or capillary gel electrophoresis.
• Working experience in HPLC/UPLC method development.
• Experience with enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for biologics or nucleic acid therapies.
• This position requires conducting laboratory experiments, excellent documentation review and writing skills, and the flexibility to work on multiple projects as needed.
• Understanding of process development, and/or regulatory aspects of mRNA-(lipid) nanoparticle products would be a plus.
• Ability to quickly adapt to change and thrive in a dynamic and entrepreneurial early-stage environment.
• A strong team player with excellent oral and written communication skills and a demonstrated ability to work independently.
• Independently motivated, detail oriented and good problem-solving ability.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $120,000 - $142,000 annually plus bonus and equity incentives

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. 

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. 

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. 

Tango’s labs and offices are located at 201 Brookline Avenue, in the vibrant Fenway area of Boston, Massachusetts

Summary 

We are seeking a Clinical Supply Manager (CSM) to lead the end-to-end clinical supply management process of our growing clinical portfolio. This role will serve as the primary sponsor contact for external vendors managing the packaging and labeling, storage, distribution, and return/ destruction of clinical supplies.

In a fast-paced, small biotech environment, the CSM will plan, execute and oversee clinical supplies in alignment with trial timelines, budget, regulatory requirements and internal standards. This individual will play a key role in enabling clinical trial start, patient enrollment, and continuous supply as per trial requirements, proactively identifying and mitigating risks, and ensuring compliance of clinical supply with applicable regulations and internal standards.

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your role

• Develop and maintain global clinical supply strategies, including forecasting needs for investigational products, comparators, and co-medications
• Oversee inventory levels at depots and clinical sites, defining resupply strategies based on usage trends to prevent shortages
• Coordinate distribution, importing, and exporting of materials
• Ensure all activities comply with Good Manufacturing Practices (GMP), ICH guidelines, and internal standards
• Manage external vendors (incl. budget), such as Clinical Manufacturing Organizations (CMO), packaging partners and depots
• Track vendor performance using metrics, KPIs, and KRIs
• Act as the primary clinical supplies contact for Clinical Trial Teams (CTT), Chemistry, Manufacturing, and Controls (CMC), and quality assurance (QA)
• Organize and coordinate meetings with key stakeholders, including decision tracking and action item follow-up
• Generate optimal distribution plans and develop tools, forms etc. to track and document end-to-end processes
• Trigger and track shipments of clinical supply from central depot to regional hubs and local depots
• Contribute to Information Response Technology (IRT) set-up, testing and maintenance in close collaboration with relevant CTT functions to ensure efficiency, timeliness and accuracy of clinical supplies management
• Provide input into label text as well as into packaging and labeling materials
• Identify and assesses risks and issues related to clinical supplies, proactively communicate them and lead the development and implementation of mitigation strategies and action plans
• Ensure inspection and audit readiness of clinical supplies; participate in internal audits and inspection from health authorities, as required.

What You Bring

• 5+ years of supply management experience. Experience in leadership preferred
• Bachelor’s degree in Life Sciences, Pharmacy or related field
• Experience working in global clinical development organization
• Experience in Oncology development (preferred)
• Experience in outsourcing and oversight
• Direct experience with health authority inspections of clinical supply management (preferred)
• Knowledge of relevant regulations and guidelines (GMP, ICH guidelines, HSE)
• Knowledge of appropriate supply chain systems used for forecasting and demand planning as well as supply management metrics, KPIs, and KRIs
• Familiarity with other systems used in clinical trials (e.g., CTMS, IRT, eTMF)
• Strong operational excellence with high attention to details
• Strong vendor management and project management skills
• Leadership skills with the ability to lead cross-functional teams
• Strong interpersonal and communication skills
• Strong analytical thinking and decision-making capabilities

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

We are seeking a Clinical Trial Leader (CTL) to lead cross-functional clinical trial teams (CTTs) in the execution of clinical trials of Tango’s portfolio. This role will chair the CTT and represent the cross-functional team to internal governance bodies. The CTL will be an internal escalation point for other CTT members.

In a fast-paced, small biotech environment, the CTL will operationally lead the set-up, conduct and reporting of clinical trials as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your role

• Lead cross-functional Clinical Trial Team (CTT) in the planning, execution, and reporting of outsourced clinical trial.
• Provide regular updates to internal governance bodies.
• Serve as the primary liaison between the sponsor and CRO to ensure alignment of trial objectives, timelines, and deliverables.
• Oversee CRO performance, ensuring adherence to scope, budget, and timelines.
• Contribute to protocol development and review of key study documents (e.g., ICFs, CRFs, monitoring plans).
• Lead the development of trial-specific plans including risk management, communication, and oversight plans.
• Support site selection and feasibility assessments in collaboration with CRO and internal stakeholders.
• Monitor trial progress through metrics and KPIs.
• In collaboration with Operational Excellence and Compliance, define an optimal RBQM framework to efficiently control quality throughout the trial.
• Proactively identify risks and issues and support the development and implementation of mitigation strategies and action plans.
• Ensure timely delivery of trial milestones including patient recruitment, data collection, and interim analyses.
• Manage trial budgets, change orders, and invoice reconciliation in collaboration with vendor management and finance.
• Ensure study conduct in compliance with ICH GCP, ISO standards, regulatory requirements, and internal standards.
• Participate in audits and inspections. Ensure timely resolution of findings.
• Review and approve essential documents and study deliverables.
• Oversee database lock, clinical study report (CSR) development, and study close-out activities.
• Contribute to regulatory submissions and responses as needed.

What You Bring

• 8+ years of trial management experience with 3+ years in trial leadership position.Bachelor’s degree in Life Sciences, Pharmacy or related field (required).
• Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred).
• Experience working in global clinical development organization.
• Experience in Oncology development (preferred).
• Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
• Experience in outsourcing and oversight.
• Knowledge of ICH GCP, FDA guidelines, EU CTR and other relevant guidelines.
• Knowledge of financial planning, tracking, and reporting.
• Knowledge of trial risk assessment and management.
• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs.
• Strong vendor management and project management skills.
• Excellent leadership skills with the ability to lead cross-functional teams.
• Strong interpersonal and communication skills.
• Strong analytical thinking and decision-making capabilities.
• Willingness to travel, as required (typically 10–20%)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

Company Overview 

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. 

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. 

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. 

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts. 

Summary

We are seeking a Global Program Operations Head (GPOH), reporting into the Vice President, Clinical Operations, to lead the strategic and operational execution of a portfolio of clinical trials within a designated disease area. This role partners cross-functionally with Clinical, Medical, Regulatory, and Operational Excellence to ensure programs are aligned with corporate goals, regulatory requirements, and operational feasibility. 

You will drive program-level strategy, oversee trial execution, and manage Contract Research Organizations (CROs) and external vendors, ensuring delivery against timelines, budgets, and quality expectations. Additionally, you will lead and develop a high-performing clinical operations team while supporting governance, risk management, and inspection readiness in a fast-paced biotech environment. 

Your Role 

• Oversee the strategic and operational execution of a portfolio of clinical trials within a designated disease area

• Ensure alignment with corporate goals and regulatory standards

• Represent Global Clinical Operations in Global Program Teams (GPTs) and sub-teams, contributing to program-level strategy and operational planning

• Collaborate with Medical and Regulatory Directors to ensure clinical strategies are scientifically sound, meet regulatory requirements, and are operationally feasible

• Partner with Operational Excellence & Clinical Compliance to align on risk assessment, trial- and site management metrics, KPIs, and KRIs 

• Define and implement outsourcing strategies in partnership with the VP of Global Clinical Operations and Head of Clinical Sourcing & Contracting

• Lead the selection, negotiation, contracting, and performance oversight of CROs and external vendors 

• Monitor trial progress and key deliverables, guiding Clinical Trial Teams (CTTs) in execution planning, issue resolution, and risk mitigation

• Manage program and trial budgets, ensuring accurate forecasting, cost control, and financial accountability

• Track CRO/ vendor performance using metrics, KPIs, KRIs and participate in governance meetings to address escalated issues and drive continuous improvement

• Provide regular updates on trial progress to internal governance bodies, including GPT and Executive Leadership Team

• Support inspection readiness activities and represent the organization during Health Authority inspections 

• Provide leadership, coaching, and performance management to Clinical Trial Leaders (CTLs), Clinical Contract Managers (CTMs), Clinical Trial Specialists (CTSs), and Site Management Leader (SMLs)

• Set clear objectives, deliver ongoing feedback, and develop tailored development plans to support team growth and capability building

• Oversee hiring, onboarding, and training of new team members, fostering a culture of operational excellence and continuous learning

What You Bring 

• 12+ years of trial management experience with 7+ years in leadership position 

• Bachelor’s degree in Life Sciences, Pharmacy or related field (required). Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred). 

• Significant experience working in global clinical development organization

• Experience in Oncology development (preferred)

• Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections

• Significant experience in outsourcing and oversight

• Expert knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines

• Expert knowledge in financial planning, tracking, and reporting

• Expert knowledge in risk assessment and management on program and trial-level

• Executive presence and strategic thinking on corporate-, program-, and trial-level

• Strong decision‑making and sound judgment 

• Strong leadership and interpersonal skills 

• High credibility with senior leadership 

• Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs

• Willingness to travel, as required (typically 10–20%)

 #LI-Hybrid

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status

Company Overview 

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. 

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. 

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. 

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts. 

Summary

We are seeking a Clinical Contract Manager (CCM) to lead the end-to-end clinical site contracting process in support of our growing clinical portfolio. This role will serve as the primary sponsor contact for Contract Research Organization (CRO) partners and internal stakeholders across Clinical, Legal, Finance, and Compliance. 

In a fast-paced, small biotech environment, the CCM will drive the development, negotiation, execution, and maintenance of Clinical Trial Agreements (CTAs), ensuring alignment with trial timelines, budget, and regulatory requirements. This individual will play a key role in enabling timely site activation, CTA maintenance as per trial requirements, proactively identifying and mitigating risks, and ensuring compliance of CTAs with applicable regulations and internal standards. 

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your Role 

• 5+ years of trial management experience with 3+ years in site management 

• Bachelor’s degree in Life Sciences, Pharmacy or related field 

• Experience working in global clinical development organization 

• Experience in Oncology development (preferred) 

• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred) 

• Experience in outsourcing and oversight 

• Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs 

• Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act) 

• Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines 

What You Bring 

• 5+ years of trial management experience with 3+ years in site management 

• Bachelor’s degree in Life Sciences, Pharmacy or related field 

• Experience working in global clinical development organization 

• Experience in Oncology development (preferred) 

• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred) 

• Experience in outsourcing and oversight 

• Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs 

• Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act) 

• Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines 

 #LI-Hybrid

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status

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.

We are looking for a Senior Clinical Data Engineer to join our Research Operations team, which drives the end-to-end execution of studies that drive new feature development and validation. You’ll manage the data that forms the foundation of our clinical trials—ensuring that data pipelines are fast, transparent, and comply with all applicable regulations. 

In this role, you’ll work at the frontier of R&D health sensing and gain hands-on experience with every part of the clinical database lifecycle: from design and validation through database lock and archival. Working closely with our regulatory, software, and science teams, you’ll raise the bar for how Oura runs clinical studies. 

This is a remote US role with a preference for candidates based on the East coast.

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

What You’ll Do:

• Oversee the clinical data lifecycle for a portfolio of studies: ensuring timelines and data integrity are maintained.
• Work closely with research project managers, algorithm developers, data engineers, and external vendors to align data management activities with broader trial objectives.
• Identify data-related risks and implement mitigation strategies, while driving process improvements and adopting emerging technologies as needed.
• Lead data quality management, query analysis, optimization, deduplication, auditing, and validation of regulated data ecosystems.
• Develop and oversee the design of Case Report Forms (CRFs) and electronic data capture (EDC) systems to ensure accurate, complete, and protocol-compliant data collection.
• Build the Clinical Data Repository that will form the backbone of all research and regulatory work at Oura

We would love to have you on our team if you have:

• 7+ years of industry experience with clinical data management
• Fluency with regulations such as ICH GCP, 21 CFR Part 11, and standards such as CDISC (SDTM/ADaM)
• Proficiency in an industry-standard EDC system (e.g. Medidata Rave, Castor, REDCap) and data engineering tools (e.g. AWS S3, Glue, Athena; Databricks; Dagster; dbt)
• Experience bridging clinical data management and research with enterprise practices and standards
• Comfort with building dashboards using tools like Tableau or Databricks
• Flexibility with scheduling to enable calls with global collaborators

Benefits 

At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.

What we offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and mental health resources
• An Oura Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave

Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Region 1 $172,550 - $203,000
• Region 2 $158,950 - $187,000
• Region 3 $147,900 - $174,000

A recruiter can determine your zones/tiers based on your US location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI)

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in Texas, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in the Northeast (Boston/New York), with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in California, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment. 

Key Responsibilities

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. 
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements. 
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. 
• Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. 
• Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.  
• Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions. 
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
• Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance. 
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.  
• Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities. 

Qualifications

•  PharmD or PhD in scientific field
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.  
• Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required. 
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
• Experience supporting clinical safety case processing and aggregate reporting.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
• CNS experience preferred. 

Compensation 

The annual base salary range for this job level is $145,000 to $190,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location 

Based in the US, with <10% travel.

POSITION: Full-Time, Exempt

Description of Role

The Sr. MSL will serve as a field-based scientific expert responsible for engaging with healthcare professionals (HCPs), supporting clinical development, and ensuring alignment with Centessa’s strategic medical objectives. This role is critical in translating complex scientific data into meaningful clinical insights and fostering compliant, evidence-based dialogue with thought leaders.

Key Responsibilities

Scientific Expertise & Thought Leader Engagement

• Maintain a high level of therapeutic area expertise and scientific knowledge relevant to Centessa’s pipeline and marketed products in alignment with Medical Affairs strategic objectives
• Engage in compliant, non-promotional scientific exchange with key opinion leaders (KOLs), investigators, and other HCPs
• Serve as a trusted scientific resource to external stakeholders, providing accurate and balanced medical information
• Deliver company-approved, high-quality medical/scientific presentations to a variety of audiences including formulary committees and healthcare professionals.
• Provide medical/scientific support for critical Centessa activities including speaker training, advisory boards, and sales training as appropriate
• Ensure accurate, timely, and compliant documentation of field-based activities in accordance with MSL organization guidelines

Clinical Trials Support

• Collaborate with Clinical Operations to identify and evaluate potential clinical trial sites and investigators based on scientific expertise, patient population, and alignment with study objectives
• Provide scientific education and protocol-specific training to investigators and site staff during site initiation visits, ensuring thorough understanding of study rationale and endpoints
• Maintain ongoing engagement with trial sites and investigators to facilitate successful execution of clinical trial objectives, provide ongoing scientific support, address protocol-related inquiries, and ensure high-quality data generation

Medical Conference Attendance & Coverage

• Attend relevant scientific and medical congresses to stay current with emerging data and trends
• Provide real-time insights and post-conference reports to internal teams
• Support Centessa’s presence at congresses through development of pre-conference plans, booth coverage, symposia participation, and KOL engagement
• Senior MSLs will be responsible to leading strategic conference planning, execution, and reporting

Scientific Materials Development

• Contribute to the development of scientific slide decks, FAQs, and educational materials
• Writing and editing Medical Information response letters
• Ensure all materials are medically accurate, evidence-based, and compliant with regulatory standards
• Collaborate with Medical Affairs and Legal teams to ensure scientific content meets internal and external guidelines

Additional Responsibilities:

• Lead MSL strategic initiatives/projects aligned with Medical Affairs and MSL organization strategy
• Develop and implement scientific training plans for the MSL team
• Contribute to MSL organization strategy in collaboration with MSL leadership
• Mentorship of MSL peers

Qualifications

• Advanced degree (PhD, PharmD, MD, DP, PsyD, DNP) in life sciences or a related field (from An Accredited College or University).
• Minimum 4+ years' experience as an MSL for a drug development company in the pharmaceutical/biotech industry
• Demonstrated understanding of sleep medicine and/or associated neuroscientific areas required 
• Exceptional verbal and written communication skills; ability to tailor scientific messages to diverse audiences and ability to interpret and communicate complex scientific data
• Proven ability to build and maintain strong relationships with KOLs, investigators, and internal stakeholders
• Strong understanding of clinical trial design, regulatory requirements, and therapeutic area landscape
• Skilled in developing and delivering scientific presentations in various settings
• Strong understanding of industry regulations and guidelines governing medical interactions
• Ability to align field activities with broader medical and corporate strategies
• Senior MSLs have a proven ability to lead and mentor peers
• Must have a valid driver’s license with a driving record that meets company requirements
• Must reside within the New England region or the New York Metro area.
• Willing and able to travel frequently within assigned territory (Boston, New York, Philadelphia, Baltimore, Detroit, Cleveland, Cincinnati)

Compensation

The annual base salary range for the Senior MSL job level is $190,000 - $230,000.

Individual compensation within these ranges will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Sr. MSL - Northeast is a remote role based in the US, with up to 60-70% travel and occasional weekends

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a diverse pipeline spanning early development through late-stage and registrational programs. Reporting to the Executive Director, Clinical Pharmacology, this position is accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely with cross-functional teams and represents clinical pharmacology in regulatory interactions to enable efficient, data-driven advancement of therapies across our neuroscience portfolio.

Key Responsibilities

• Lead clinical pharmacology strategy for CNS and neuroscience programs from first‑in‑human through registrational and post‑marketing stages 
• Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑ascending dose, DDI, biopharmaceutics, and patient studies 
• Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS‑specific biomarkers  
• Lead model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets and clinical safety
• Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers  
• Serve as the clinical pharmacology lead on program teams, clinical sub‑teams, and trial working groups 
• Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)  
• Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions  
• Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs  
• Oversee CROs and external vendors conducting clinical pharmacology and modeling activities  
• Ensure timely communication and clear interpretation of clinical pharmacology results to internal stakeholders 
• Contribute to portfolio strategy, program prioritization, risk mitigation, and long‑range clinical development planning for CNS assets 
• Serve as a subject‑matter expert on clinical pharmacology 
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow  
• Ensure high‑quality, submission‑ready documentation aligned with global regulatory standards 

Qualifications

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline 
• 8–12+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in clinical drug development 
• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support 
• Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment 
• Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization  
• Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent 
• Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities  
• Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development  
• Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment 

Compensation 

The annual base salary range for this position is $270,000.00 to $295,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location

The Senior Director, Clinical Pharmacology role is a remote role based in the US, with occasional travel. 

POSITION: Full-Time, Exempt

Description of Role

Centessa is seeking a (Senior) Clinical Trial Manager (CTM) to lead the execution of mid‑ to late‑stage global clinical studies from study start‑up through close‑out and clinical study report. The (Sr) CTM is responsible for day‑to‑day trial management, coordinating internal cross‑functional teams and overseeing CROs and external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards. This role requires hands‑on involvement in clinical trial execution, proactive identification and resolution of operational issues, and accountability for study performance metrics and deliverable quality. The (Sr) CTM also contributes to operational planning, risk assessment, and continuous process improvement in collaboration with study team leadership.

Key Responsibilities

• Plan and execute mid‑ to late‑stage CNS clinical trials from study start‑up through close‑out, ensuring operational excellence, high data quality, and compliance with protocol, GCP, and global regulatory requirements.
• Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
• Oversee CROs and external vendors supporting CNS clinical trials, including co‑monitoring activities, to ensure delivery against scope of work, timelines, budget, and quality expectations.
• Drive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials.
• Review and approve CRO‑ and vendor‑generated plans and study documentation, ensuring alignment with protocol, regulatory expectations, and Centessa quality standards.
• Monitor study progress and performance using operational metrics and tools, maintaining dashboards, timelines, and financial tracking, and providing clear, timely status updates to study teams and management.
• Identify, assess, and manage operational risks, proposing practical mitigation strategies and supporting informed decision‑making to minimize impact to timelines, quality, and patient safety.
• Ensure inspection and audit readiness, including oversight of Trial Master File (TMF) set‑up, ongoing maintenance, and close‑out for CNS studies.
• Contribute to operational planning and regulatory deliverables, supporting preparation of study‑level documentation for Health Authority interactions and continuous improvement of clinical operations processes.

Qualifications

• Bachelor’s degree in a scientific or health‑related discipline.
• 5-8 years clinical trial management experience within an industry sponsor environment, supporting drug development programs.
• Experience managing clinical trials in CNS therapeutic development strongly preferred.
• Proven ability to manage global clinical studies, including coordination with investigators, CROs, and functional vendors.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements applicable to clinical trials.
• Solid understanding of project management principles, including planning and managing timelines, resources, budgets, and risk–benefit trade‑offs; PMP or similar training is a plus.
• Excellent communication, collaboration, and interpersonal skills, with the ability to influence without formal authority and drive cross‑functional team performance.
• Demonstrated ability to manage multiple priorities in a fast‑paced environment, meeting aggressive timelines while maintaining quality.
• Proactive problem‑solving mindset with the ability to anticipate issues, identify creative solutions, and take initiative to address risks impacting timelines or budgets.

Compensation

The annual base salary range for the Clinical Trial Manager is $120,000 - $150,000.

The annual base salary range for the Senior Clinical Trial Manager is $145,000-$190,000.

Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The (Senior) Clinical Trial Manager is a remote role based in the US, with occasional travel (10% - 15%). 

POSITION: Full-Time, Exempt

Description of Role

Centessa is growing its clinical development organization. Reporting to the SVP, Clinical Development, the Executive will provide medical leadership and oversight to Centessa’s programs and associated clinical trials. The role requires leadership and contributions both at a strategic level and hands-on project level work.  Executive Director will have prior experience in the biotech/pharma industry, in neurodegenerative/neuropsychiatric therapeutic areas and across the development cycle of an asset (early to late phase).  

RESPONSIBILITIES:

• Primary point of contact for clinical development activities with willingness to work strategically and hands on at the program and clinical trial levels.
• Accountable for the oversight, monitoring and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and optimal integrity of data.
• Responsible for establishing relationships and communication with KOLs, investigators and relevant site medical (or other supportive roles) personnel.
• Lead the clinical development strategy and innovative approaches for the overall clinical pathway for the asset.
• Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings.
• Play a key role in regulatory and health authority interactions.
• Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc.
• Author asset and clinical trial level plans, charters, documents.
• Determine optimal clinical trial design options that are innovative, patient centric, cost efficient, and enable meeting business goals. 
• Responsible for review, analysis and interpretation of all clinical trial data including assessment of protocol deviations.
• Lead asset level clinical sub-teams and play key leadership role on program team for clinical development.
• Lead asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.).  
• Attend and present as needed at core team meetings, investigator meetings, site visits, etc.
• Liaise with cross functional partners, vendors, and CROs to ensure the progression of clinical studies within the expected time frame.
• Provide clinical evaluation and interpretation of pre-clinical results.
• Remain current on the development of  orexin agonists and  the relevant therapeutic areas through review of the scientific literature, interactions with KOLs and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of Centessa clinical stage programs. 

QUALIFICATIONS:

• MD required, MD/PhD strongly preferred (includes internationally recognized equivalent)
• Minimum 10 years of overall experience (academia, clinical practice, pharma/biotech industry, etc.)
• Minimum 5 years of pharmaceutical/biotech industry experience, including managing clinical development and clinical science teams, clinical development programs and clinical trials
• Prior pharma/biotech and line management experience – Required
• CNS therapeutic area (particularly neurodegenerative/neuropsychiatric) experience- Required
• Willingness to deliver project and tactical level work
• Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines.  Knowledge or experience supporting regulatory or health authority inspections a plus.
• Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions.
• Experience authoring and guiding teams with key asset and clinical trial level plans and documents.
• Strong knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc.
• Possess excellent written and oral communication skills with internal and external stakeholders
• Proven ability to work collaboratively, take initiative, solve complex issues, and deliver results in a fast-paced, team-based matrix environment
• Demonstrate sound judgement in handling complex, confidential, and highly regulated information
• Ability and willingness to travel as required.

The annual base salary range for this level is $300,000.00 to $375,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Executive Director, Clinical Development role is a remote role based in the US, with occasional travel.

About the Position 

As Associate Director of RWD Intelligence at Formation Bio, you will lead the strategy and execution of our real-world data (RWD) capabilities, building the data foundations that power drug acquisition, clinical development, and portfolio decision-making. You will own the end-to-end lifecycle of RWD: sourcing, procurement, ingestion, harmonization, quality assurance, and delivery of analysis-ready datasets to downstream consumers across Product, Data Science, Clinical Development, and Business Development.

This role sits at the intersection of data engineering, data science, and drug development. You will build and maintain scalable data infrastructure (pipelines, data models, lakes/marts) while ensuring semantic interoperability across heterogeneous data sources through ontology-driven harmonization frameworks such as OMOP. You will also manage vendor relationships and data procurement, evaluating and integrating new data assets as the portfolio evolves. The ideal candidate combines deep RWD domain expertise with strong data fluency, enabling Formation Bio to treat real-world evidence as a first-class strategic asset.

Responsibilities

• Lead the RWD Intelligence function within Data Science, owning data strategy, sourcing, and delivery of analysis-ready datasets
• Architect and maintain the supporting infrastructure (pipelines, ingestion workflows, data models, lakes/marts) across EHR/EMR, claims, registries, and genomics-linked cohorts
• Drive adoption and extension of harmonization frameworks (e.g., OMOP CDM) across heterogeneous data sources, leveraging AI/ML tools for entity resolution, ontology mapping, data quality monitoring, and automated harmonization
• Manage RWD vendor relationships end-to-end: evaluate providers, negotiate data use agreements, broker new partnerships, and integrate acquired datasets into the platform
• Partner with Data Science, Clinical Development, Business Development, and Engineering teams to define RWD use cases (trial feasibility, synthetic control arms, epidemiology, label expansion) and productize ad hoc pipelines into scalable, production-grade systems
• Foster a culture of data quality rigor, documentation, and reproducibility across all RWD assets

About You 

Required Qualifications

• BSc or MSc in biomedical informatics, computational sciences, epidemiology, or a related quantitative field
• 5+ years of industry experience working directly with real-world data (EHR/EMR, claims, registries, linked biobank data) in pharma, biotech, health tech, or consulting, with at least 2+ years in people management
• Strong data engineering proficiency (pipelines, ingestion frameworks, data models, data lakes/marts) combined with deep working knowledge of biological and medical ontologies (ICD, SNOMED CT, MedDRA, RxNorm, ATC) and harmonization standards, particularly OMOP CDM
• Demonstrated experience with RWD procurement and vendor management: evaluating data providers, negotiating agreements, and integrating new data assets
• Proven ability to deliver RWD-derived insights across multiple drug development use cases (e.g., trial design, epidemiology, comparative effectiveness, label expansion), with familiarity across the development lifecycle from target selection through post-market
• Proficiency with modern AI/ML tools, including large language models, and their applications in data engineering and harmonization workflows
• Strong communication skills with the ability to translate complex data infrastructure concepts for clinical, scientific, and executive audiences

Preferred Qualifications

• PhD in biomedical informatics, epidemiology, computational biology, or a related field
• Experience with large-scale biobank and genomics-linked RWD platforms (UK Biobank, FinnGen, All of Us), with a track record of building RWD infrastructure that directly influenced drug acquisition, licensing, or portfolio decisions
• Familiarity with additional biomedical data modalities (scientific literature mining, -omics datasets, molecular data integration) and with data science/analytics methodologies applied to RWD (causal inference, trial simulation, propensity score methods)
• Background transitioning data infrastructure from research/ad hoc to production-grade systems in regulated environments
• Experience working at the intersection of data engineering, data science, and business strategy in pharma/biotech

Total Compensation Range: $204,500 - $267,000

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.

Your impact:

As a Senior Clinical Trial Associate, you’ll be a key player in keeping our clinical studies on track—managing the details, supporting the team, and helping bring innovative treatments to patients

Your day-to-day:  

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc.
• Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
• Perform quality checks on the study TMF with oversight of study COL
• Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc. May coordinate and track clinical trial equipment and supplies
• Review and track vendor invoices against contracts with oversight of study COL
• Coordinates and tracks administrative aspects of contract execution and PO generation
• Supports the trial team to produce and distribute study newsletters
• Supports collection and updating of clinical trial insurance
• Supports posting of all agreed clinical trials to publicly available websites
• Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
• May support additional ad-hoc activities as agreed with the study COL

Must-Haves:

• Bachelor's degree in life sciences or healthcare related field
• 3+ years' experience in a clinical trial support position, experience in Biotech or Pharma strongly preferred
• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Ability to multitask and flex across projects as priorities and deadlines shift
• Ability to maintain confidentiality of proprietary information
• A team player that takes initiative and is proactive 

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $90,000-$110,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

Reporting to the Vice President, Investor Relations and Corporate Communications, we are hiring a strategic communicator to oversee Product and Pipeline Communications for vopimetostat, our lead PRMT5 inhibitor, and other oncology pipeline candidates. This is an opportunity to create and deliver communications programs in support of clinical data, development efforts, and potential patient benefits.

Your role

• Lead communications for vopimetostat, covering data, regulatory milestones, and commercial launch
• Develop cross-functional messaging
• Execute disease awareness, branded campaigns, integrations, and digital/social media initiatives
• Partner with Clinical Development and Operations team to support clinical trial communications, including development of digital assets
• Collaborate with Clinical Development, Medical Affairs, Patient Advocacy, Regulatory, Legal, IR, Internal Communications, and external partners
• Represent the function on integrated teams and contribute to business decisions
• Support executive engagement through media, speaking opportunities, and internal communications
• Manage issues proactively to protect reputation; use analytics to assess communication strategies

What You Bring

• Bachelor’s degree with 10 plus years of experience in public relations or communications within the pharmaceutical or biotech industry
• Strong understanding of oncology drug development, regulatory policy, medical meeting and publications strategy
• Expertise in issues management within drug development
• Ability to adapt quickly in fast-changing environments
• Demonstrated success working in cross-functional, matrixed teams with an enterprise approach
• Preferred qualifications: Public relations or communications experience in oncology

This is a Hybrid/Flexible role!

#LI-Hybrid

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

**We are only hiring for this role in the CST or EST time zones**

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

We are looking for a commercially-minded, revenue-driven, highly technical Solutions Engineer to join our organization with a heavy focus on selling to software engineering teams. Reporting to the Director of Product Marketing, you are responsible for translating our product strategy into confident, effective value-based selling. You will work alongside Sales to support live deals, bring product and technical depth into buyer conversations, and turn field experience into reusable assets that scale across GTM. You focus on the last mile of the buying journey - proving technical fit, reducing risk, and helping buyers move forward with confidence. While you are a strategic partner to Sales on active deals, being situated within the Product Marketing team allows you to act as a critical bridge between our product’s capabilities and our market-facing message. You are a technical storyteller who knows how to connect "how it works" with "why it matters." You’ll use real-world deal experience to stress-test and refine our positioning, competitive strategy, and the assets we use to win.

Responsibilities

Value Selling & Deal Execution

You own technical confidence in active deals and are accountable for buyer certainty in our technical fit. Your performance is largely measured by your impact on revenue.

• Technical Discovery & Diagnosis: Lead additional deep-dive discovery during demos to uncover a prospect’s current tech stack and pain points. You help diagnose the technical "why" before prescribing a solution.
• Value-Based Demonstrations: Deliver demos tailored to the buyer’s specific goals and success criteria. Lead with value and differentiation, not feature walkthroughs.
• Trial & Evaluation Ownership: Own the trial experience end-to-end, including setup, guidance, and success criteria. Ensure trials clearly demonstrate value and differentiation.
• Technical Deal Support: Act as a persistent partner in the deal, not a one-time resource. Stay current on deal status, identify technical risks, and partner with AEs to move deals forward.
• Expansion & RFP Support: Support expansions and at-risk renewals. Partner with AEs and PMM to ensure RFPs have high positioning impact and technical clarity.

Technical Assets & Demo Environments

You are responsible for maintaining the "technical sales toolkit," ensuring the GTM team has accurate, field-ready assets to sell efficiently.

• Scalable Asset Creation: Build and maintain reusable technical sales assets—such as walkthroughs, video snippets, and PoC templates for APIs/integrations—that help the field scale.
• Demo Environment Ownership: Maintain stable and accessible demo environments. You ensure demo data supports realistic, value-based storytelling for our core personas.
• Demo Narrative: Collaborate with PMM to ensure the core demo narratives are technically accurate and reflect how the product is actually used in the field.

Cross-Functional Collaboration & Enablement

You act as the resident technical authority, ensuring seamless alignment between the Product, Marketing, and Sales organizations.

• Cross-Functional Collaboration: Serve as the trusted technical lead for AEs, AMs, and CSMs. You are a strong collaborator who bridges the gap between technical details and GTM strategy.
• Product Readiness: Stay current on what’s shipping and why it matters. Translate new features into demo-ready flows, technical FAQs, and narratives for the GTM team.
• Field Intelligence Loop: Serve as the "voice of the buyer." Identify patterns in technical objections or competitive gaps and provide clear, actionable feedback to Product to influence the roadmap.

Candidate Profile

• Commercially Minded: You understand that technical depth exists to win deals and drive revenue.
• Strategic Partner: You know when to lead technically and when to support the broader sales strategy.
• Solution Storyteller: You can translate product capabilities into outcomes that actually matter to a buyer.
• Ownership Mindset: You treat deals, proof points, and internal process improvements as your personal responsibility.

Qualifications

• Technical Sales Experience: Proven track record delivering value-led technical demonstrations to software engineers and highly technical buyers, translating complex platform capabilities (APIs, integrations, developer workflows) into clear business and technical outcomes.
• Software Development Fluency: Strong working knowledge of modern SDLC practices, including requirements management, Git-based version control, CI/CD workflows, and release processes, with hands-on experience using Jira and similar developer tools (e.g., issue tracking, sprint boards, workflow configuration) in real engineering environments.
• API & Integration Literacy: Practical understanding of REST APIs, authentication methods, and system integrations - confident discussing how systems connect, how data flows between platforms, and how traceability or automation is maintained.
• Code Familiarity: Hands-on familiarity with code platforms (you have written or actively used code-based tools) and can speak fluently about repositories, commits, pull requests, and automation workflows.
• SaaS Background: Experience at a small-to-mid-sized SaaS company where you helped build or refine the SE function, processes, or demo environments - not just operate within an established structure.
• Revenue Impact: A clear track record of directly supporting revenue, advancing complex opportunities, and influencing deal outcomes in partnership with Account Executives.
• Learning & Ownership Mindset: Thrives in a fast-moving, evolving environment — actively seeks feedback, adapts quickly, rolls with change, and contributes ideas that help the team continuously improve how we sell and deliver technical value.
• Nice to Have: Experience in life sciences/medtech environments or running technical proof-of-concepts.

Benefits you’ll enjoy:

• Flexible Paid Time Off policy and working hours
• Home Office stipend for new hires
• Multiple Medical Insurance options, plus Dental and Vision
• 401k (with company match) 
• Equity Program Eligibility (based on role and/or tenure)
• Paid Maternity and Paternity Leave
• Disability insurance

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango’s clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling. This role is ideal for someone who thrives in a dynamic environment, excels at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making.

Your Role

• Lead the clinical data management partnership with CROs, ensuring seamless execution of Tango’s clinical trials
• Provide oversight for fully outsourced data management activities from RFP to final database lock, working closely with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools
• Develop and/or author key data management documents, including database design specifications, edit checks, CRF completion guidelines, and Data Management Plans, ensuring compliance with CDASH and SDTM standards
• Partner with cross-functional teams to standardize data collection and reporting processes, enhancing efficiency and data quality
• Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
• Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks
• Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
• Collaborate with internal and external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure projects are delivered on time and within budget
• Participate in study team meetings, providing updates, addressing issues, and ensuring data is effectively collected, reviewed, and analyzed

What you bring

• Bachelor’s degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms like Metadata Rave
• 5-8 years of experience leading the data management of clinical trials, from study start up through database lock, within an industry sponsor, ideally focusing on oncology or rare diseases
• Strong vendor management and oversight experience
• Solid technical skills across data platforms; programming experience preferred
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
• Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
• Experience in regulatory GCP inspections/audits preferred
• Experience with Spotfire, elluminate or other data visualization software
• Ability to manage multiple projects in a fast-paced environment

This is a Hybrid/Flexible role!

#LI-HYBRID

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

About the Position

Formation Bio is hiring Product Leads to own major problem domains across our drug development platform - for example, how we evaluate and acquire drug assets, how we design and run clinical trials, or how we build regulatory submissions. You will report to the CTO. 

This is a product leadership role, but not a traditional one. You won't be writing specs for engineers to build. You'll own a business domain: set the strategy, define what to build, lead a cross-functional team through delivery, and be measured on whether the work actually changes outcomes for the drug programs and business functions you serve. Your team will include engineers, data scientists, and product managers (ranging from senior ICs to managers).

You will be embedded with our clinical, translational, regulatory, and business development leaders - understanding their problems deeply enough to identify where technology can make a material difference. That means learning what makes a drug asset attractive, what drives a trial design decision, what the FDA cares about, and where the real time and cost sinks are. You should be able to drive value in a clinical review meeting in the same way you drive value in a sprint planning session.

We are not building consumer software. We are building tools, models, and systems that make specific drug development decisions faster and better - prediction models that assess drug candidate viability, AI-driven workflows that compress diligence timelines, and platforms that let non-engineers build their own analytical tools. You will own a slice of that work and be accountable for its impact.

Responsibilities

• Own the product strategy for a defined problem domain (e.g., drug candidate evaluation, clinical trial execution, regulatory intelligence). Define what to build, what to deprioritize, and how to measure success.
• Drive adoption of AI across your domain. We use LLMs, agentic workflows, and autonomous systems extensively. You should be pushing what's possible, not waiting for the technology teams to propose it.
• Design systems that domain experts across the company can build on directly. Non-engineers are already creating their own technology - your solutions should accelerate that, not bottleneck it.
• Lead a cross-functional team spanning engineering, data science, and product. Set the roadmap and make resourcing trade-offs based on business impact.
• Work directly with our core functional teams as a strategic tech partner. Translate their problems into technology solutions - not by taking feature requests, but by understanding the domain well enough to see opportunities they may not.
• Guide the data science and engineering approach within your domain, including real-world evidence analysis, prediction pipelines, clinical strategies, and dataset evaluation. You need enough technical judgment to know when an approach is sound and when to push back.
• Maintain awareness of regulatory constraints. You don't need to be a regulatory expert, but you need to build products that work within GxP requirements and clinical data governance standards.

About You

• 10+ years of experience in tech delivery with progressively broader scope, including at least one role where you led product or technology strategy and were held accountable for business outcomes.
• Life sciences experience: You've built products in biotech, pharma, or a related industry. You understand the drug development lifecycle well enough to have informed opinions about where technology does and doesn't help. You've worked in an environment shaped by regulatory constraints and scientific uncertainty.
• Strategic product thinker: You define product direction based on business outcomes, not feature velocity. You've owned a product area where success was measured in terms the business cared about - time saved, decisions improved, cost reduced - not just user engagement or ship rate.
• AI fluency: You can evaluate AI/ML approaches, make build-vs-buy decisions on AI capabilities, and push your team to use AI where it creates real leverage. You've deployed or led the deployment of LLM-based or agentic systems in a professional context.
• Technical fluency: You can engage deeply with engineers and data scientists on approach, architecture, and trade-offs. You can evaluate whether an ML model is solving the right problem, whether a data pipeline is reliable enough, and whether an engineering approach will scale.
• Cross-functional leadership: You've led teams that included engineers, data scientists, and product managers. You know how to hire, develop, and hold people to high standards.
• Business fluency: You can discuss clinical trial design, asset valuation, regulatory strategy, and competitive dynamics with senior leaders without retreating to technical jargon. You've been in rooms where the conversation was about business decisions, not product decisions, and you contributed.
• Comfortable with ambiguity and autonomy: You are highly adaptable and curious. You've worked in early-stage companies, on transformation efforts or new initiatives where the scope was unclear and the playbook didn't exist. That energizes you rather than stalls you.
• Mission-driven: You care about getting medicines to patients faster. That's what this company exists to do, and it matters to you.

Total Compensation Range: $374,000 - $467,000

About the Position 

As a Data Scientist on the platform prediction team, you'll translate our probability of success predictions into measurable portfolio-level outcomes. You'll architect core systems — order management, execution simulation, portfolio construction, risk monitoring, and performance attribution — that let us rigorously evaluate signals from our AI-driven predictions in public and private equities and our internal portfolio.

This role sits at the intersection of quantitative finance, healthcare data, and AI-driven drug development. If you're excited about applying portfolio construction and risk management fundamentals to one of the most consequential prediction problems in healthcare, this is the role.No other company — hedge fund or pharma — has a technical data science position translating drug development experience into durable AI-native portfolio strategies. The skills you develop here — portfolio construction over assets with radically asymmetric risk profiles, clinical trial analytics, AI/ML in production, and risk management across multi-year horizons — can directly impact the delivery of new and effective therapeutics to patients by best aligning impactful medicines with economic incentives.

Responsibilities

• Work with the team to implement and maintain core portfolio engine: order management system, execution simulation layer, portfolio construction service, and performance tracking
• Design risk frameworks that quantify exposure across a portfolio of drug development bets with radically different risk profiles, timelines, and failure modes
• Run rigorous backtesting experiments with strict temporal constraints to evaluate Formation strategies against baseline approaches and measure marginal signal from new evidence sources
• Coordinate across the organization to integrate internal Formation data sources (clinical trial data, genomic evidence, real-world data) and proprietary tooling into portfolio analytics pipelines
• Work with product and engineering teams to build dashboards and reporting that communicate portfolio performance, risk metrics, and strategy comparisons to both technical and executive stakeholders
• Collaborate with the broader data science team to ensure portfolio-level evaluation feeds back into model improvement and evidence prioritization

About You 

Required Qualifications

• MS or PhD in a quantitative field (statistics, finance, physics, computational science, engineering, or related)
• 1-3 years in a quantitative research, data science, or analytics role — finance, healthcare, academic research, or consulting all count; substantive internships qualify
• Strong Python programming skills with experience in data-intensive workflows (pandas, numpy, scipy)
• Solid grasp of core portfolio construction and risk concepts: position sizing, rebalancing, Sharpe ratio, drawdown, volatility, benchmark comparison
• Demonstrated ability to work with messy, real-world datasets — comfortable with data wrangling, deduplication, and quality assessment
• Clear communicator who can present quantitative results to both technical peers and business stakeholders

Preferred Qualifications

• Experience with backtesting frameworks or portfolio simulation (vectorbt, Backtrader, or custom implementations)
• Exposure to healthcare, pharma, or biotech data (clinical trials, claims data, -omics, real-world evidence)
• Familiarity with alternative data in a research or investment context
• Experience with probability-of-success modeling, drug development decision analysis, or health economics
• Comfort with LLMs or AI/ML pipelines in a production or research setting
• Familiarity with dashboard/visualization tools (Streamlit, Plotly, Dash) and pipeline orchestration (Dagster, Airflow)

Healthcare OR finance domain knowledge is valued; both are not required.

Total Compensation Range: $154,500 - $202,000

About the Position 

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. The role will oversee external bioanalytical partners and drive execution for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity, including assay approach selection, validation strategy, sample analysis oversight, data review, and submission-ready documentation. In partnership with Clinical Pharmacology, DMPK/Nonclinical, Clinical Operations, Regulatory, and data teams, this role will help scale Formation Bio’s Trial Engine by standardizing bioanalytical workflows, improving traceability, and enabling consistent, analysis-ready bioanalytical outputs across programs.

Responsibilities

• Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
• Define assay plans and validation approaches (fit-for-purpose through full validation) for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity
• Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
• Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
• Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
• Ensure data quality and audit readiness for assigned deliverables through strong documentation practices, traceability, and alignment to regulatory guidance and internal standards
• Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
• Coordinate with Clinical Operations on sample logistics (kits, handling, stability, chain of custody, reconciliation) and resolution of operational issues impacting bioanalysis
• Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
• Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
• Work with Biostatistics/Data Science to enable clean data transfers, consistent formats/metadata, and analysis-ready datasets
• Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
• Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions that improve speed and consistency across programs

About You 

• PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
• Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
• Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR
• Familiar with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation
• Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation
• Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed
• Comfortable operating in a fast-paced, cross-functional environment with multiple concurrent priorities
• Clear communicator who can translate technical detail into program-relevant recommendations
• Preferred: Experience functioning as part of a clinical study team to integrate tradeoffs between vendor selection, development speed, assay quality and performance, and applicability of method to deliver value to program overall
• Preferred: Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
• Preferred: Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

Total Compensation Range: $177,500 - $232,000

About the Position

As the Director of Data Science at Formation Bio, you will be at the forefront of revolutionizing drug development through AI and advanced analytics. In this role, you'll lead crucial initiatives that directly impact our drug development portfolio, from developing sophisticated models for patient selection to creating AI-powered solutions for clinical trial optimization. You'll work at the intersection of computational biology, machine learning, and drug development, collaborating with cross-functional teams to translate complex biological data into actionable insights. This position offers a unique opportunity to shape the future of pharmaceutical development by leveraging cutting-edge AI technologies while making a meaningful impact on patient lives. 

Responsibilities

• Lead and execute complex data science projects that directly advance our drug development portfolio 
• Develop and implement sophisticated models for therapeutic hypothesis evaluation, including patient stratification and biomarker identification
• Design and create AI models for modernizing clinical trial evaluations, including surrogate endpoints 
• Aid in the development and training of AI agents to automate and optimize biomedical workflows 
• Collaborate cross-functionally with clinical, technical, and research teams 
• Present complex analytical findings to senior stakeholders, including executive leadership 

About You

Required Qualifications 

• PhD in computational sciences or life sciences 
• 7+ years of post-academic experience in life sciences (biotech, pharma, consulting) 
• Strong programming skills, particularly in Python 
• Extensive experience in multi-modal bioinformatics analysis 

Preferred Qualifications 

• Proven expertise in cloud computing environments, including proficiency with tabular and/or graph databases 
• Strong background in machine learning and deep learning, particularly in biological applications 
• Experience with large language models (LLM)
• Demonstrated ability to collaborate effectively with engineering teams on production systems
• Strong communication skills with proven ability to present complex technical findings to senior stakeholders 

Total Compensation Range: $235,000 - $307,000

About the Position

As a Principal Data Scientist at Formation Bio, you will be at the forefront of revolutionizing drug development through AI and advanced analytics. In this role, you'll lead crucial initiatives that directly impact our drug development portfolio, from developing sophisticated models for patient selection to creating AI-powered solutions for clinical trial optimization. You'll work at the intersection of computational biology, machine learning, and drug development, collaborating with cross-functional teams to translate complex biological data into actionable insights. This position offers a unique opportunity to shape the future of pharmaceutical development by leveraging cutting-edge AI technologies while making a meaningful impact on patient lives. 

Responsibilities

• Lead and execute complex data science projects that directly advance our drug development portfolio 
• Develop and implement sophisticated models for therapeutic hypothesis evaluation, including patient stratification and biomarker identification
• Design and create AI models for modernizing clinical trial evaluations, including surrogate endpoints 
• Aid in the development and training of AI agents to automate and optimize biomedical workflows 
• Collaborate cross-functionally with clinical, technical, and research teams 
• Present complex analytical findings to senior stakeholders, including executive leadership 

About You

Required Qualifications 

• PhD in computational sciences or life sciences 
• 5+ years of post-academic experience in life sciences (biotech, pharma, consulting) 
• Strong programming skills, particularly in Python 
• Extensive experience in multi-modal bioinformatics analysis 

Preferred Qualifications 

• Proven expertise in cloud computing environments, including proficiency with tabular and/or graph databases 
• Strong background in machine learning and deep learning, particularly in biological applications 
• Experience with large language models (LLM)
• Demonstrated ability to collaborate effectively with engineering teams on production systems
• Strong communication skills with proven ability to present complex technical findings to senior stakeholders 

Total Compensation Range: $204,500 - $267,000

About the Position

As a Principal Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to integrate advanced imaging analytics and AI into our drug development pipeline. In this role, you'll pioneer the application of computer vision and deep learning to medical imaging data (MRI, X-ray, CT, PET) to accelerate clinical trials and improve patient outcomes. You'll develop state-of-the-art models for automated image analysis, disease progression monitoring, and treatment response assessment. Working closely with clinical teams, radiologists, and drug development experts, you'll translate complex imaging data into actionable insights that drive key decisions across our portfolio. This position offers a unique opportunity to revolutionize how medical imaging is leveraged in pharmaceutical development while directly impacting patient care.

Responsibilities

• Lead the development of advanced deep learning models for medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications
• Design and implement automated image processing pipelines for disease detection, segmentation, and quantification across multiple therapeutic areas
• Create innovative approaches for longitudinal image analysis to track disease progression and treatment efficacy in clinical trials, incl. AI-based biomarkers and surrogate endpoints
• Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows
• Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints
• Build scalable infrastructure for processing and analyzing large-scale medical imaging datasets from multi-site clinical trials
• Present imaging insights and model performance to executive leadership and external partners

About You

Required Qualifications 

• PhD in Computer Science, Biomedical Engineering, Medical Physics, or related field with focus on medical imaging
• 5+ years of post-PhD industry experience developing production-grade AI models for medical imaging applications
• Deep expertise in computer vision and deep learning architectures (CNNs, U-Net, Vision Transformers) for medical image analysis
• Proven track record with MRI and X-ray image analysis, including hands-on experience with DICOM standards and medical imaging software
• Strong programming skills in Python with expertise in PyTorch/TensorFlow and medical imaging libraries
• Demonstrated ability to collaborate with radiologists and clinical teams to translate medical insights into technical solutions
• Strong communication skills with proven ability to present complex imaging analytics to diverse stakeholders

Preferred Qualifications 

• Experience with regulatory submissions involving imaging endpoints or AI-based image analysis tools
• Experience with multi-modal imaging fusion and analysis (combining MRI, CT, PET data)
• Knowledge of clinical trial design and experience with imaging core lab operations
• Experience with federated learning or privacy-preserving techniques for medical imaging
• Understanding of radiomics and quantitative imaging biomarker development
• Experience with 3D image reconstruction and volumetric analysis

Total Compensation Range: $204,500 - $267,000

About the Position

We're looking for a Senior Data Engineer to join the Scientific Data Intelligence (SDI) team at Formation Bio to help transform Real World Data (RWD)—spanning electronic health records, claims, and other longitudinal patient data sources—into structured, analytics-ready assets. In this role, you'll be partnering closely with our Data Science team not only to model and transform data, but also to actively analyze it: answering research questions, generating evidence, and supporting scientific decision-making across our drug portfolio.

This position sits at the intersection of healthcare data engineering, real-world evidence analysis, and generative AI. While a strong foundation in building reliable, scalable pipelines is essential, you'll be equally expected to roll up your sleeves and work directly with the data—constructing cohorts, running analyses, and translating findings into actionable insights for scientific and business stakeholders.

The ideal candidate is a hybrid of data engineer and applied scientist: someone who can build the infrastructure and then use it, with familiarity in RWD study design, GenAI fluency (e.g., LLM-based entity extraction, summarization, classification), and strong technical expertise with modern data tooling. You'll play a key role in shaping how real-world patient data becomes discoverable, structured, and impactful across the organization.

Responsibilities

• Model and transform raw EHR and claims data into clean, canonical, and analytics-ready datasets using SQL, Python, and clinical standards like OMOP.
• Build and manage scalable data pipelines using Dagster for orchestration, dbt for transformation, and Snowflake as the primary compute and storage engine.
• Conduct hands-on RWD analyses to answer scientific and strategic research questions—including disease epidemiology, treatment patterns, patient journey characterization, and comparative effectiveness.
• Partner with Data Scientists and clinical leads to design and execute observational studies, translating scientific questions into well-structured, reproducible analyses.
• Implement data validation, completeness, and observability frameworks to ensure real-world datasets are accurate, comprehensive, and trustworthy for downstream research and product use.
• Apply Generative AI techniques within transformation and analysis layers to accelerate data structuring and insight generation.
• Communicate findings clearly to both technical and non-technical stakeholders, including summaries for portfolio teams and leadership.

About You

• You have 5+ years of experience in data engineering, ideally with at least 2 years working in healthcare or life sciences, including direct exposure to EHR or claims datasets.
• You have experience with ontologies and biomedical schemas (e.g. UMLS, LOINC, ICD9/10, MeSH) and understand the modalities found within RWD — billing claims, lab results, visit notes.
• You're fluent in SQL and Python, and you've built and maintained production-grade pipelines that support analytics or scientific workflows.
• You have experience building longitudinal patient cohorts from EHR or claims data, including index date logic, washout periods, and follow-up window construction.
• You have a solid understanding of the causal inference frameworks such as potential outcomes and target trial emulation. 
• You have working familiarity with real-world evidence study design concepts—such as active comparator new user designs, time-to-event outcomes, confounder adjustment, and causal discovery algorithms—sufficient to partner effectively with Data Scientists on causal inference workflows.
• You value clarity, documentation, and structured thinking—especially when working with complex healthcare data.
• You have hands-on expertise with modern data infrastructure, such as Snowflake, dbt, and Dagster.
• You can balance upfront design with speed to execution, slowing down when it counts without getting stuck in the details.
• Bonus: You've worked in regulated or privacy-sensitive data environments and are familiar with governance models for PHI or sensitive data.
• Bonus: You have prior experience working with commercial RWD vendors (e.g. Truveta, Optum, Komodo, IQVIA) and understand the nuances of licensed claims and EHR datasets, including longitudinal patient journey construction and line-of-therapy sequencing.

Total Compensation Range: $204,500 - $267,000

About the Position

As a Senior Data Scientist at Formation Bio, you will be at the forefront of revolutionizing drug development through AI and advanced analytics. In this role, you'll lead crucial initiatives that directly impact our drug development portfolio, from developing sophisticated models for patient selection to creating AI-powered solutions for clinical trial optimization. You'll work at the intersection of computational biology, machine learning, and drug development, collaborating with cross-functional teams to translate complex biological data into actionable insights. This position offers a unique opportunity to shape the future of pharmaceutical development by leveraging cutting-edge AI technologies while making a meaningful impact on patient lives. 

Responsibilities

• Lead and execute complex data science projects that directly advance our drug development portfolio 
• Develop and implement sophisticated models for therapeutic hypothesis evaluation, including patient stratification and biomarker identification
• Design and create AI models for modernizing clinical trial evaluations, including surrogate endpoints 
• Aid in the development and training of AI agents to automate and optimize biomedical workflows 
• Collaborate cross-functionally with clinical, technical, and research teams 
• Present complex analytical findings to senior stakeholders, including executive leadership 

About You

Required Qualifications 

• PhD in computational sciences or life sciences 
• 3+ years of post-academic experience in life sciences (biotech, pharma, consulting) 
• Strong programming skills, particularly in Python 
• Extensive experience in multi-modal bioinformatics analysis 

Preferred Qualifications 

• Proven expertise in cloud computing environments, including proficiency with tabular and/or graph databases 
• Strong background in machine learning and deep learning, particularly in biological applications 
• Experience with large language models (LLM)
• Demonstrated ability to collaborate effectively with engineering teams on production systems
• Strong communication skills with proven ability to present complex technical findings to senior stakeholders 

Total Compensation Range: $170,000 - $215,000

About the Position

As a Senior Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to integrate advanced imaging analytics and AI into our drug development pipeline. In this role, you'll pioneer the application of computer vision and deep learning to medical imaging data (MRI, X-ray, CT, PET) to accelerate clinical trials and improve patient outcomes. You'll develop state-of-the-art models for automated image analysis, disease progression monitoring, and treatment response assessment. Working closely with clinical teams, radiologists, and drug development experts, you'll translate complex imaging data into actionable insights that drive key decisions across our portfolio. This position offers a unique opportunity to revolutionize how medical imaging is leveraged in pharmaceutical development while directly impacting patient care.

Responsibilities

• Lead the development of advanced deep learning models for medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications
• Design and implement automated image processing pipelines for disease detection, segmentation, and quantification across multiple therapeutic areas
• Create innovative approaches for longitudinal image analysis to track disease progression and treatment efficacy in clinical trials, incl. AI-based biomarkers and surrogate endpoints
• Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows
• Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for clinical trial endpoints
• Build scalable infrastructure for processing and analyzing large-scale medical imaging datasets from multi-site clinical trials
• Present imaging insights and model performance to executive leadership and external partners

About You

Required Qualifications 

• PhD in Computer Science, Biomedical Engineering, Medical Physics, or related field with focus on medical imaging
• 5+ years of post-PhD industry experience developing production-grade AI models for medical imaging applications
• Deep expertise in computer vision and deep learning architectures (CNNs, U-Net, Vision Transformers) for medical image analysis
• Proven track record with MRI and X-ray image analysis, including hands-on experience with DICOM standards and medical imaging software
• Strong programming skills in Python with expertise in PyTorch/TensorFlow and medical imaging libraries
• Demonstrated ability to collaborate with radiologists and clinical teams to translate medical insights into technical solutions
• Strong communication skills with proven ability to present complex imaging analytics to diverse stakeholders

Preferred Qualifications 

• Experience with regulatory submissions involving imaging endpoints or AI-based image analysis tools
• Experience with multi-modal imaging fusion and analysis (combining MRI, CT, PET data)
• Knowledge of clinical trial design and experience with imaging core lab operations
• Experience with federated learning or privacy-preserving techniques for medical imaging
• Understanding of radiomics and quantitative imaging biomarker development
• Experience with 3D image reconstruction and volumetric analysis

Total Compensation Range: $177,500 - $232,000

About the Position

Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading and developing the biostatistics team and strategy, driving impactful statistical initiatives, and leveraging biostatistics to advance our drug development processes.

The Senior Director, Biostatistics will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality statistical contributions across clinical development. They will also collaborate cross-functionally to integrate advanced analytics, data-driven decision-making, and AI applications into our development programs to improve efficiency and increase the probability of success.

Responsibilities

• Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development to ensure team growth and expertise.
• Statistical Strategy & Innovation: Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success.
• Study Design & Execution: Provide expert statistical input into clinical study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial design options to identify the most effective clinical development strategy that aligns with business needs and optimizes decision-making. Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. Leverage AI-driven clinical trial automation to enhance study execution, optimize resource allocation, and improve trial efficiency.
• Regulatory & Cross-Functional Collaboration: Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA) to ensure statistical rigor in clinical development plans.
• Operational Excellence: Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
• Data-Driven Decision-Making: Champion data-driven approaches and quantitative decision-making frameworks, integrating scenario analyses and statistical trial simulations to optimize clinical trial execution and strategic development plans.
• External Engagement: Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations.
• Vendor & CRO Management: Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards.

About You

• Ph.D. in Biostatistics, Statistics, or a related field with 10+ years of experience in biostatistics within the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development.
• Proven experience leading biostatistics teams and strategies within clinical development.
• Deep expertise in statistical trial designs, adaptive designs, Bayesian methods, and simulation-based approaches for both early and late-stage development.
• Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions.
• Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions. 
• Demonstrated track record of leading statistical contributions to progress assets from diligence, early development through regulatory submissions and approvals.
• Ability to collaborate cross-functionally with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
• Strong problem-solving skills with the ability to balance scientific rigor with operational efficiency.
• Excellent communication skills, with the ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies.
• Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus.
• Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development.

Total Compensation Range: $311,000 - $385,000

About the Position 

Formation Bio is seeking a bold and forward-thinking Vice President of Engineering to lead and transform our technical capabilities into a strategic driver of clinical and commercial success. This critical leadership role will report to the CTO and serve as a senior thought partner in defining how sophisticated engineering and computational frameworks can fundamentally reshape drug development and asset acquisition.

The ideal candidate is a biotech-native technical leader who understands that our goal is not to build traditional software products, but to develop deep technical capabilities that drive hard insights. You will partner closely with Product to translate complex scientific and operational bottlenecks into high-leverage technology solutions that accelerate workflows and deliver higher-quality insights. You will oversee the engineering behind complex data science analyses - including Real-World Evidence (RWE) platforms, large-scale information ingestion pipelines, and comprehensive modeling - that move the needle for pharma decision-making. You bring the vision and [biotech] experience to ensure our technical foundation supports clinical-stage assets and highly regulated R&D workflows with precision and speed.

Responsibilities

• Define and execute a technical vision that prioritizes high-leverage computational capabilities over traditional software features, ensuring engineering effort directly increases drug asset quality and value.
• Act as a core collaborator for the CTO and leadership team, translating complex clinical and business bottlenecks into scalable engineering solutions.
• Embed engineering resources within Business Development, Clinical, and R&D units to leverage technology to address operational needs.
• Partner with Data Science to build the engineering architecture required for complex analysis, including Real-World Evidence (RWE) platforms, asset screening frameworks, and prediction pipelines.
• Collaborate with Product to build specialized tools that streamline R&D workflows, moving the needle from manual efforts to technology-augmented insight generation.
• Develop and scale proprietary platforms for the ingestion and operationalization of external, clinical, and biological datasets.
• Ensure the delivery of GxP-validated clinical environments and automated security compliance, maintaining a regulatory-first posture without sacrificing speed.
• Deploy and scale LLM-integrated features and autonomous agents to drive multiplier efficiencies across the organization.
• Manage and mentor a specialized engineering organization, fostering a high-performance culture that values technical rigor, interdisciplinary collaboration, and mission-driven delivery.
• Refine the team structure to maintain high talent density and quality engineering in a fast-paced biotech environment.

About You 

• 10+ years of experience in software/data engineering and technical leadership, with a significant background in the Boston biotech or pharma-tech ecosystem.
• Biotech Intuition: You have likely been a VP of Engineering at 2–3 different biotechs and possess a deep understanding of the drug development lifecycle, from Discovery through Phase III.
• Proven People Leader: Experience managing and mentoring a team of 15+ engineers, with a track record of driving results in highly technical, interdisciplinary environments.
• Capability mindset: You understand that we aren't building a "user app"; we are building an engine for insights. You are passionate about the backend engineering required for RWE, data science, and trial automation.
• Engineering Rigor: Deep expertise in building data ingestion pipelines and managing complex, heterogeneous biological and clinical datasets.
• Regulatory Fluency: Experience working within GxP (GCP, GLP, GMP) environments. You know how to build technical capabilities that are "regulatory-ready" from day one.
• Strategic Partner: You are comfortable discussing risk-adjusted NPV, asset-level ROI, and clinical trial bottlenecks with CEOs, CMOs, and investors.
• Mission-Driven: Passionate about using hard engineering to solve the drug development bottleneck and bring life-changing treatments to patients faster.

Total Compensation Range: $347,000 - $435,000

ESSENTIAL JOB FUNCTIONS:

The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. May also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. This role leads and is accountable for the Medical Writing and Clinical Trial Transparency & Disclosure functions. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. There will need to be a very strong understanding of document timelines as planning is critical.

• Provides leadership, strategy, and oversight of the Medical & Regulatory Writing team.
• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Ph.D. degree is preferred.
• Strong track record of people management and delegating work.
• 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Leads decision-making across multiple programs or areas, setting direction and making strategic trade-offs that impact cross-functional execution and outcomes.
• Drives cross-functional alignment across multiple programs, influencing stakeholders to shape strategy and ensure cohesive execution across functions.
• Understanding of FDA and ICH regulations and guidelines.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for this role at the Senior Director level is $265,000 - $306,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Join Our Team as Clinical Trial, Commercial & R&D Counsel at Axiom

Location: Remote

We are seeking experienced attorneys to support legal teams within the pharma and health systems space. This role focuses on drafting, reviewing, and negotiating a broad range of commercial and research-related agreements, with an emphasis on global work, clinical research organizations (CROs), and research & development (R&D) transactions. Both full-time and part-time opportunities are available.

Key Responsibilities

• Draft, review, and negotiate a wide range of agreements, including:
  • Master Services Agreements (MSAs)
  • Statements of Work (SOWs)
  • Clinical Trial Agreements (CTAs)
  • Non-Disclosure Agreements (NDAs) and Confidential Disclosure Agreements (CDAs)
  • Consulting Agreements
• Provide legal support for global transactions and cross-border collaborations
• Advise on and support engagements with Clinical Research Organizations (CROs)
• Handle R&D-related legal work, including:
  • Pre-clinical research agreements
  • Sponsored research agreements (e.g., industry–academic collaborations)
  • Material Transfer Agreements (MTAs)
• Support licensing and collaboration agreements within the life sciences space
• Partner with business stakeholders, including business development and licensing (BD&L) teams, on strategic and operational initiatives
• Contribute to structuring and negotiating research collaborations and related transactions

Qualifications

• J.D. and active bar membership in good standing
• Experience in the pharmaceutical, biotech, medical device, or health system sectors (a blend is preferred)
• Demonstrated experience in at least one of the following priority areas:
  • Global transactional experience
  • Working with Clinical Research Organizations (CROs)
  • R&D legal work, including pre-clinical and sponsored research
• Familiarity with intellectual property transactions in the life sciences space
• Experience supporting licensing, collaboration, and research agreements
• Strong drafting, negotiation, and stakeholder management skills

Compensation: 

The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year and for non-attorney roles is $71,250-309,750 per year. Compensation decisions are based on various factors, including, but not limited to, experience, skills, certifications, location, and business needs.  Employees may be eligible for additional benefits, including health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools. 

About Axiom: 

For over 25 years, Axiom has pioneered the alternative legal services industry, now serving more than 1,500 legal departments globally with our unique blend of world-class legal talent and advanced AI tools, delivering innovative solutions ranging from that combine top-tier talent with cutting-edge technology. We tackle complex legal matters across 12 practice areas for clients ranging from Fortune 100 to SMBs, empowering our legal professionals to engage in meaningful work that advances their careers. Our Talent NPS score of +71% and our Client NPS score of +64% highlight our commitment to excellence (Reported scores were Axiom’s average for 2025 – the legal industry average NPS score is +35%). Join our forward-thinking community where you’ll keep your career dynamic and multi-faceted, be part of a company that values agility, collaboration, and excellence, and love both the law and your life. 

Learn more about life at Axiom.  

Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape with best in class alterative legal services.   

Diversity is core to our values and we are proud to be an equal opportunity employer. Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender, gender identity, gender identity status, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. 

Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require accommodations to participate in each stage of the recruitment process. To request an accommodation, please contact benefits@axiomlaw.com. 

Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full data privacy notice is available here.    

Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. Pursuant to the San Francisco Fair Chance Ordinance, NY Fair Chance Act, and Los Angeles Fair Chance Initiative, we will consider for employment qualified applicants with arrest and conviction records. 

 #LI-LC3

This role is based in Boston, MA with onsite presence required Monday-Wednesday

Your impact:

In this role, you’ll work with our Clinical Operations Leads to help keep trials running smoothly across multiple indications. It’s a hands-on, high-impact role on a fun, driven team where you’ll grow fast and make a real difference. 

Your day-to-day:  

• Provide support to the Clinical Operations Lead (COL) in the planning, execution, and oversight of a global phase 3 clinical trial from study start-up to close-out.
• Support the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration.
• Support start-up activities to help accelerate country and site activations.
• Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
• Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.   
• Contribute to inspection readiness activities and ensure compliance with GCP and SOPs.
• Help identify and resolve site risks and/or issues to foster positive site relationships.
• Coordinate internal team meetings and participate in cross-functional study meetings.
• Proactively communicate study updates with key internal and external stakeholders.

Must-Haves:

• Bachelor’s degree preferably in life sciences or healthcare related field.
• 5+ years of clinical operations experience within the biotech or pharma industry required
  • Title and level commensurate with experience  
• Experience managing outsourced global clinical trials across Phase I–III.
• Prior involvement in study start-up activities strongly preferred
• Solid understanding of GCP, ICH guidelines, and the clinical development process.
• Experience with clinical trial management systems (CTMS), eTMF, and other operational tools.
• Ability to multitask and flex across projects as priorities and deadlines shift.
• Highly organized with excellent communication and interpersonal skills.
• Strong attention to detail and ability to multitask in a dynamic, fast-paced setting.
• A collaborative team player that takes initiative.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for the Associate Clinical Trial Manager is $115,000-$135,000 and for Clinical Trial Manager it is $140,000-160,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.

Location: Boston, MA preferred

The Associate Director, Clinical Data Management (CDM) is an individual contributor and leadership role within Vor's Biometrics organization, responsible for strategic oversight and operational delivery of all clinical data management activities across Vor's clinical portfolio. This individual will serve as one of Vor's internal CDM experts leading study and program-level data governance, owning EDC architecture and data standards, managing CRO and vendor partnerships, and ensuring continuous regulatory inspection readiness. 

This role will be accountable for department-level strategy, SOP ownership, regulatory inspection representation as a named CDM subject matter expert, and cross-regional data integration from multi-national studies. The Associate Director serves as a senior escalation point and represents the CDM function at program governance forums and regulatory interactions. 

Key Responsibilities 

1. CDM Strategy & Portfolio Oversight 

• Contribute to the strategic and operational leadership for multiple CDM activities across Vor's clinical portfolio, from protocol synopsis through database lock, archiving, and regulatory submission. 

• Serve as the CDM functional lead on program teams, contributing to clinical development plans, protocol design, and study feasibility assessments from a data quality and operability perspective. 

• Define and communicate CDM strategy, standards, and milestone timelines at the study and program level; identify risks early and communicate mitigation plans to senior leadership. 

• Partner with Biostatistics and Statistical Programming to ensure seamless data flow from EDC through SDTM/ADaM datasets and downstream regulatory analyses. 

2. EDC Platform Ownership & Data Standards — Medidata Rave 

• Serve as Vor's primary subject matter expert (SME) and platform owner for Medidata Rave EDC, governing the full ecosystem: study build, library management, edit check strategy, change control, and system validation. 

• Lead development and governance of Vor's CDASH-aligned CRF standards library within Medidata Rave — ensuring consistency, reusability, version control, and regulatory/submission alignment across all programs. 

• Oversee CRF design, database build specifications, UAT strategy, and production release quality control across all active studies. 

• Ensure EDC configurations comply with CDISC CDASH/SDTM standards, facilitating optimal downstream dataset programming for regulatory submissions. 

• Evaluate and implement emerging Medidata capabilities (e.g., eConsent, eCOA integrations, Medidata AI data monitoring) to advance quality and operational efficiency. 

• Maintain governance of edit check specifications, data review guidelines, and coding conventions (MedDRA, WHODrug) across all Vor studies. 

3. Cross-Regional Data Integration & Bridging Studies 

• Lead the CDM strategy for multi-regional clinical trials, including studies with non-US-originated or non-US-concurrent data (e.g., bridging studies, ICH E17-compliant global programs). 

• Oversee data transfer, reconciliation, and harmonization from non-US regional CROs and data platforms, ensuring data integrity when integrating datasets from non-US investigational sites or partners into global submissions. 

• Partner with Regulatory Affairs and Biostatistics to define data requirements for integrated global analyses and data pooling strategies (per ICH E17) for FDA and EMA submissions. 

• Ensure regional data collection practices — including eCRF language localization, coding dictionary alignment, and site training materials — satisfy both local regulatory requirements and Vor global data standards. 

• Manage data transfer specifications and reconciliation protocols for all third-party data streams: central labs, IRT, safety databases, eCOA, and regional CRO-generated datasets. 

4. Regulatory Inspection Readiness & Direct Inspection Representation 

• Ensure Vor's CDM documentation, TMF data management sections, and EDC audit trails are maintained in a state of continuous inspection readiness throughout the study lifecycle. 

• Serve as the CDM subject matter expert and primary spokesperson in regulatory inspections (FDA, EMA, competent authority), audits, and quality reviews — directly answering inspector and auditor questions on data management practices, EDC systems, data integrity, and audit trail review. 

• Prepare CDM inspection packages including data management plans, system validation documentation, audit trail narratives, and data quality metrics for regulatory review. 

• 5. CRO & Vendor Management 

• Serve as Vor's senior CDM oversight lead for external CRO DM partners — including contract scope definition, performance governance, issue escalation authority, and quality review. 

• Establish and enforce CDM expectations, SOW deliverables, and quality metrics for all external vendors: CROs, EDC service providers, central labs, IRT vendors, and eCOA/ePRO platforms. 

• Review and approve all key DM vendor deliverables: data management plans, CRF completion guidelines, edit check specifications, data transfer agreements, and database lock packages. 

• Lead vendor qualification activities and contribute to CRO selection processes as a CDM technical evaluator. 

6. Quality, Compliance & SOP Governance 

• Develop, maintain, and continuously improve Vor's CDM SOPs, work instructions, templates, and data management plans in alignment with ICH E6(R3), FDA 21 CFR Part 11, EU Annex 11, GCDMP, and CDISC standards. 

• Ensure compliance with electronic records and electronic signatures regulations across all EDC systems and data management platforms. 

• Track and report data quality metrics, query resolution rates, cleaning milestones, and database lock timelines to program teams and leadership. 

7. Cross-Functional Collaboration 

• Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Medical Writing, and Safety to ensure CDM activities support all downstream deliverables. 

• Partner with Clinical Operations on site training, data entry guidance, and site data quality monitoring. 

• Provide CDM input into clinical study reports, regulatory briefing documents, and submission-ready data packages. 

• Represent CDM on study teams, program governance boards, and senior leadership forums. 

8. Leadership & Talent Development 

• Provide mentorship, technical guidance, and professional development support to Sr. Data Managers and Data Managers within the CDM team. 

• Contribute to workforce planning and hiring, helping define and scale CDM capabilities as Vor's pipeline grows. 

• Foster a high-performance, quality-first team culture aligned with Vor's clinical mission. 

Qualifications 

Education 

• Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field required. 

• Advanced degree (Master's or equivalent) preferred. 

• CCDM (Certified Clinical Data Manager) certification is a plus. 

Required Experience 

• Minimum 10 years of clinical data management experience in pharmaceutical, biotech, or CRO settings, with at least 3 years in a senior lead or management role. 

• Expert-level proficiency with Medidata Rave EDC — including study build, CRF design, edit check authoring, library management, UAT oversight, and production release governance. 

• Demonstrated prior experience as the named CDM representative in FDA or EMA regulatory inspections — directly answering inspector questions on data management practices, audit trails, and data integrity. 

• Hands-on experience with multi-regional clinical data management including integration of data from China-based or other non-US studies, data transfer reconciliation, and bridging study data strategies. 

• Deep knowledge of CDISC standards (CDASH, SDTM), ICH guidelines (E6, E8, E9, E17), FDA 21 CFR Part 11, EU Annex 11, and GCDMP. 

• Proven CRO and vendor oversight experience across full study lifecycles from startup through database lock and archiving. 

• Proficiency with coding dictionaries (MedDRA, WHODrug) and data review/cleaning methodologies. 

Preferred Experience 

• Background in autoimmune disease and/or rare disease is a plus.  

• Prior experience with front-line communications during regulatory inspections.  

• Prior experience building or scaling a CDM function in a lean, clinical-stage biotech environment. 

• Familiarity with eSource, decentralized trial (DCT) components, and real-time data monitoring technologies. 

• Experience with Medidata Rave Architect and/or Rave EDC Modules (eConsent, eCOA, Medidata AI). 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

Skills & Competencies 

• Demonstrated ability to communicate complex data management concepts clearly and concisely — both in polished written deliverables and confident oral presentations — to diverse audiences including clinical teams, regulatory inspectors, senior leadership, and external partners. 

• Strategic thinking with the ability to anticipate downstream data quality and submission risks and take proactive, documented action. 

• Exceptional attention to detail combined with ability to manage multiple concurrent programs under tight timelines. 

• Ability to lead and influence cross-functionally without requiring direct authority over all stakeholders. 

• Comfort operating hands-on in a lean, fast-paced clinical-stage biotech alongside strategic departmental oversight. 

• Strong vendor management and project delivery track record for high-quality data packages on time. 

• Collaborative, patient-centered mindset aligned with Vor's mission. 

The salary range for the Associate Director, Clinical Data Management is expected to be between $185,000 and $210,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

Location: Boston, MA preferred

The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.  The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies.  In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time. 
 
Responsibilities: 
 

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissions. 

• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s) 

• Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission. 

• Serve as a first point of contact for DM partners to ensure established milestones and deliverables are met with the highest degree of quality 

• Ensure the internal and external partners align and conform to data management expectations for the assigned compound and/or indication. 

• Review and provide input for all DM documentation - CRF design and completion Guidelines, Data Management Plan, Data Transfer Specifications, etc. 

• Oversee edit check specifications to support data collection and analysis required per protocol. 

• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data. 

• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.  

• Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones.  Ensure inspection readiness at all times. 

• Set expectations and communicate and a transparent, clear way and motive team members to work towards achieving the clinical goals. 

•  Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed. 

•  Develop, review, and maintain all study Data Management documentation. 

• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks. 

•  Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely. 

• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager. 

•  Provide input into improving the efficiency of data management tasks. 

•  Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives. 
   
   

Requirements 
 
 

•  Bachelor's Degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.  

• Proven hands-on, direct, individual contributor experience with all data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables. 

• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials. 

• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.  

• Proficient experience using commercial clinical data management systems and/or EDC products e.g. Medidata Rave. Must have Medidata RAVE experience.  

• Strong project management; exhibits expertise in metrics analysis and reporting methodologies. 

• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements. 

• Contribute to the growth and development of the DM team. 

• Excellent verbal and written communication skills. 

•  Professional attitude and strong interpersonal skills. 

•  Ability to work well with a multi-disciplinary team of professionals. 

•  Flexible attitude with respect to work assignments and new learning. 

•  Ability to prioritize workload. 

•  Superior attention to detail. 

•  Understanding of clinical research and the relationship of Data Management in the clinical study process. 

•  Strong technical aptitude and ability to adapt to multiple data management platforms. 

•  Strong knowledge of electronic data capture (EDC) clinical data management systems. 

• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems. 
   

Preferred Requirement(s): 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

The salary range for the Senior Data Manager is expected to be between $170,000 and $190,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit  

PathAI is seeking a full-time MD Pathologist with strong general surgical pathology skills to join our internal PathAI Pathology team to support customer Biopharma programs, and to help build state-of-the-art artificial intelligence algorithms and digital pathology products. You are a Pathologist who is keen to learn about new DP/AI technologies, is excited to work with Biopharma companies on their key programs, who has experience in biomarker assessment, and who will enjoy interacting with multidisciplinary teams. Level will be commensurate with experience. 

What You’ll Do 

• Reporting directly to the Head of Pathology, you will serve as a Pathology subject matter expert throughout the company.  You will collaborate with Pathology colleagues, Lab Ops and Clin Ops, Biopharma customer teams, project managers, machine learning scientists, and others to ensure the highest quality Pathology support.
• Collaborate with our Biopharma partners in all aspects of project development for exploratory biomarker and translational projects, as well as clinical services work related to clinical trials running through our GCP, GCLP, CAP and CLIA compliant Biopharma laboratory.
• Serve as Pathology lead on Biopharma and other projects to recommend scoring approaches, help select network or KOL Pathologists, develop and provide training to clinical trial study readers, participate in manual and digital scoring of Pathology cases in various indications, and conduct internal assay validations.
• Represent PathAI on calls and face to face with Biopharma customers and KOLs, at Congresses and Meetings, and elsewhere as needed.
• You’ll ensure the quality of annotations from the PathAI Contributor Network, the quality of Biopharma data, and compliance across all projects and programs.
• Provide Pathology subject matter expert guidance on new potential products, work with multidisciplinary teams to help develop new DP/AI models, assist in model deployments, review the outputs and statistics from the PathAI machine learning algorithms, and provide insights on the overall improvement of the output.
• Contribute to publications.

What You Bring  

• US board certification in anatomic pathology is required. 
• Expertise and experience in immunohistochemistry and biomarker assessment (ex/ Her2, PDL1 etc), and digital pathology is required. 
• A background in translational research, immuno-oncology, and biomarker development is desired. 
• Fellowship subspecialty training is highly desirable.
• The right candidate is structured and disciplined, has a natural curiosity about Biopharma programs and biomarker assessment and is also interested in the details of the machine learning field.
• You have high emotional intelligence, communicate effectively, and are flexible and solution-oriented in your approach to problem solving and your work. 
• You enjoy working with multidisciplinary teams, and are an excellent collaborator, communicator, and team player.

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

The cash compensation outlined below includes base salary or hourly wage and on-target commission for employees in eligible roles. The summary below indicates if an employee in this position is eligible for annual bonus, overtime pay and equity awards. Individual compensation packages are tailored based on skills, experience, qualifications, and other job-related factors.

Annual Pay Range:
$208,000 - $320,000

Not Overtime Eligible
Eligible for Equity

Who We Are

PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Our team, comprising diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.

We're looking for skilled and experienced engineers to join our team and help lay the groundwork for our growing software platform. We believe in using the best tool for the job. While we’re always looking to improve, in this role, those tools currently include:

• Python
• Vue.js
• Django + DRF
• Docker
• AWS: EKS, S3, RDS/PostgreSQL, SQS, MSK/Kafka

What You’ll Do 

• Solve interesting problems with code. 
• Build new features for internal and external users, and refactor existing ones to make them better.
• Work with a wide range of systems, processes, and technologies to solve problems in sustainable ways. Sometimes you'll be neck-deep in low-level systems, and other times you'll be pairing up with the front-end team on the user interface.
• Drive the architecture of our application platform, considering the team and our future product roadmap.
• Collaborate with product, design, machine learning, and infrastructure teams.
• Drive and uphold high engineering standards, bringing consistency to the codebases you encounter and ensuring software is adequately reviewed, tested, and integrated.
• Mentor, learn, and share knowledge with others along the way.
• Take responsibility for the quality of the code produced by you and the team.
• Contribute to a SaaS platform used in clinical trial workflows, ensuring reliability, data integrity, and compliance with industry standards.
• Collaborate with clinical, QA, and regulatory teams to ensure software changes meet validation expectations and support inspection readiness.

What You’ll Need

• Bachelor of Science (or higher) in Computer Science or equivalent.
• 5+ years of full life cycle development experience.
• An insatiable intellectual curiosity and the ability to learn quickly in a complex space.
• Experience and skills in designing and building Python-based (FastAPI or Django) applications.
• Experience with modern frontend JavaScript frameworks such as React, Vue, or equivalent for building responsive, user-friendly interfaces.
• Solid foundation in data structures, algorithms, and OO design.
• Ability to collaborate with a distributed team and to work autonomously on projects.
• Strong problem-solving skills and the ability to work in a fast-paced, agile environment.
• Cloud Platform experience (AWS) (knowledge of some IaC framework is a plus).
• Hands-on experience with CI/CD tools like GitLab CI is a plus.
• Knowledge of containerization technologies like Docker and container orchestration tools like Kubernetes is a plus.

We Want to Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for. 

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way. 

The cash compensation outlined below includes base salary, on-target commission for employees in eligible roles, and annual bonus targets for eligible positions. Certain roles may also qualify for overtime pay. In addition to cash compensation, some roles are eligible to participate in PathAI’s equity plan and may receive restricted stock units (RSUs). Individual compensation packages are tailored based on skills, experience, qualifications, and other job-related factors.

Annual Pay Range:
$127,500 - $195,500

Not Overtime Eligible

Eligible for RSUs

#LI-Boston

Your impact:

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands-on operational role in supporting PV across all clinical development programs.  

Your day-to-day:  

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing compliance with regulatory timelines and global regulations and guidelines
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables
• Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick-Off Meeting activities, requests for and attainment of information from cross-functional teams
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day-to-day operational oversight of pharmacovigilance service provider
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals
• Obtain close oversight of ICSR quality including performance of QC as needed
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back-up testing, and other activities as required
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement

Must-Haves:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $170,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1