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 newly created role, the Scientific Director, Medical Information & Medical Communications will serve as a senior individual contributor within Medical Affairs, responsible for owning the medical information foundation and scientific narrative across Tango’s pipeline.

This role will be central to ensuring Tango is prepared to support increasing external engagement, regulatory interactions, congress presence, publications, and future commercialization. This is an exciting opportunity to shape foundational capability during a period of significant clinical and organizational inflection.

Your Role

     Medical Information Strategy & Operations

• Lead the end-to-end medical information strategy, including oversight of external MI vendors and call center operations
• Ensure timely, accurate, compliant, and evidence-based responses to external inquiries
• Develop, maintain, and govern medical information content, including SRLs, CRLs, FAQs, and response guidance
• Own medical information SOPs, KPIs, quality metrics, audit readiness, and inspection preparedness
• Ensure alignment with pharmacovigilance, regulatory, and compliance requirements

      Scientific Narrative & Medical Communications

• Develop and maintain Tango’s core scientific platform and data narrative across indications and development stages
• Translate complex clinical, nonclinical, and mechanistic data into clear and compelling content for internal and external audiences
• Ensure consistency of scientific messaging across medical information, field materials, congress assets, and internal communications

      Publications, Congress, & Content Governance

• Partner with Medical Affairs and Clinical teams to support publication planning and execution
• Oversee development of scientific materials for major medical congresses
• Provide medical information support at congresses, as appropriate
• Participate in the Medical Review process to ensure scientific accuracy, compliance, and data integrity

      Cross-Functional Collaboration

• Collaborate closely with Medical Affairs leadership, Clinical Development, Regulatory Affairs, Corporate Communications, and Commercial (as appropriate and compliant)
• Ensure alignment between scientific communications, medical strategy, and enterprise objectives
• Perform additional duties as required to support Medical Affairs goals

What You Bring 

• Advanced scientific degree required (PharmD, PhD, or MD strongly preferred)
• 7–10+ years of experience in Medical Affairs, Medical Information, or Scientific/Medical Communications
• Oncology experience strongly preferred; experience in GI malignancies, NSCLC, or precision oncology highly valued
• Experience in clinical-stage and/or pre-commercial biotech environments
• Exceptional scientific writing, editing, and data-positioning skills
• Strong understanding of clinical development, regulatory pathways, and medical affairs operations
• Demonstrated ability to manage vendors, agencies, and cross-functional stakeholders
• Experience with Veeva MedComms and PromoMats preferred
• Ability to operate effectively through ambiguity in a resource-constrained environment
• Excellent written and oral communication skills

Work Environment

• This role may be remote, with periodic travel to Tango offices and scientific meetings
• Approximately 10–20% travel

#LI-Remote

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.

Location: Boston, MA preferred

The salary range for the Director, Regulatory Strategy is expected to be between $210,000 and $235,000 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.

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

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, 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 Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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-AD1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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-AD1

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.

ESSENTIAL JOB FUNCTIONS:

The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for the company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development.

This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle

Strategic Leadership

• Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting.
• Lead safety strategy contributions to regulatory submissions, and lifecycle management strategies.
• Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).

Safety Surveillance & Signal Management

• Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies. 
• Lead signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders.

Risk Management & Regulatory Strategy

• Provide strategic oversight for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities.
• Serve as safety representative in interactions with global regulatory authorities.
• Ensure inspection readiness and support health authority audits/inspections.

Aggregate Reporting & Safety Communications

• Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).
• Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
• Provide strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor.

Cross-Functional Collaboration

• Partner with Clinical Development on safety monitoring strategies and DMC interactions.
• Collaborate with Biostatistics on integrated safety analyses.
• Provide safety expertise to Medical Affairs and Commercial teams for post-marketing surveillance, as needed.

Compliance & Quality

• Maintain oversight of safety vendors and CROs supporting surveillance activities.
• Contribute to SOP development and continuous improvement of PV systems and processes.
• Support inspection readiness activities, internal audits and external inspections.

Team Leadership

• Mentor and develop a high-performing Safety Sciences team.
• Foster a culture of scientific rigor, accountability, and patient focus.
• Manage departmental budget and resource planning.

JOB SPECIFICATIONS:

• PharmD or PhD in life sciences preferred.
• Advanced clinical or regulatory training highly desirable.
• 12+ years of experience in pharmacovigilance or drug safety.
• 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
• Experience supporting global regulatory submissions and health authority interactions preferred.
• Strong background in oncology required.
• Experience in both clinical development and post-marketing safety preferred.
• Strong knowledge of signal detection methodologies and benefit-risk assessment.
• Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software.
• Working knowledge of industry standard safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries.
• Proven experience authoring and reviewing aggregate safety reports.
• Demonstrate a deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
• Strategic thinker, a self-starter with strong scientific judgment.
• Executive presence and ability to influence cross-functional stakeholders.
• Excellent written and verbal communication skills.

The base range for a Senior Director is $274,000 - $330,000 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

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com. 

The Role

Seaport Therapeutics is hiring a Director, Biostatistics to serve as the statistical scientific lead for one or more clinical development programs spanning Phase 1–3 within the Biometrics function. Reporting to the VP, Head of Biometrics, this role will provide strategic statistical leadership and serve as an independent statistical authority, shaping development strategies and representing Biostatistics in regulatory interactions, while also performing and guiding hands-on analysis across the clinical portfolio.

In the near term, the role will focus on leading statistical strategy, trial design, and CRO oversight for active clinical programs, ensuring regulatory defensibility and submission readiness. Over time, this leader will help build a strong statistical culture, mentor junior team members, and serve as a key contributor to the Biometrics leadership team as the organization scales.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 3–4 days per week.

Key Responsibilities

Statistical Scientific Leadership

• Serve as the program‑level statistical lead with end‑to‑end accountability for trial design, analysis, interpretation, and reporting across multiple studies.
• Proactively identify, evaluate, and implement appropriate and innovative statistical methodologies aligned with clinical objectives, regulatory expectations, and risk profile.
• Provide expert judgment on complex statistical issues including multiplicity, missing data, intercurrent events, estimands, sensitivity analyses, and data interpretation.
• Conduct literature review, methodological research, and external benchmarking to support design decisions and defend approaches scientifically.

Clinical Trial Design & Analysis

• Lead the design of clinical trials, including sample size and power calculations; endpoint and estimand strategy (ICH E9(R1)); adaptive, Bayesian, or novel designs where appropriate; and simulation studies to evaluate operating characteristics.
• Translate clinical development questions into statistically sound and efficient designs.
• Author and/or review statistical sections of protocols, SAPs, TFL shells, and clinical study reports, ensuring scientific rigor and regulatory readiness.

Regulatory Strategy & Agency Interaction

• Lead statistical contributions to regulatory interactions (IND/CTA amendments, End‑of‑Phase meetings, Type C, NDA/BLA submissions).
• Prepare and defend statistical approaches in briefing documents, response letters, and meetings with FDA, EMA, and other global health authorities.
• Serve as the statistical lead in addressing regulatory questions, objections, and post‑submission requests, including development of additional analyses as required.

Hands‑On Analysis & Interpretation

• Perform and/or closely guide hands‑on statistical analyses using SAS and R, including ad hoc analyses for safety, efficacy, and decision‑making.
• Ensure analyses are reproducible, traceable, and aligned with agreed‑upon statistical principles.
• Partner with clinical and safety teams to support ongoing data monitoring and signal evaluation.

CRO & Vendor Oversight

• Provide scientific oversight of external CROs and vendors for biostatistics, programming, and data management activities.
• Review and quality‑check SDTM/ADaM datasets, analysis outputs, and define.xml for scientific accuracy and regulatory compliance.
• Ensure end‑to‑end traceability from raw data through analysis and reporting.

Cross‑Functional Collaboration & Influence

• Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Translational teams.
• Clearly communicate statistical concepts, risks, and recommendations to non‑statistical audiences.
• Mentor junior statisticians and programmers informally; contribute to building a strong statistical culture as the organization scales.

Qualifications

• PhD in Statistics or Biostatistics (or closely related quantitative field with equivalent depth).
• 10+ years of pharmaceutical/biotechnology experience providing biostatistical leadership across clinical development.
• Demonstrated ability to function as a scientific statistical authority, resolving complex design and analysis challenges independently.
• Deep knowledge of regulatory statistical guidance and expectations, including ICH E9, E9(R1), multiplicity, missing data, adaptive designs, and sensitivity analyses.
• Proven experience leading statistical aspects of regulatory submissions and agency interactions.
• Hands‑on expertise in SAS and R, including simulations and advanced analyses.
• Strong understanding of CDISC standards (SDTM, ADaM, Define‑XML) and regulatory traceability.
• Excellent written and verbal communication skills; ability to influence and defend positions with senior stakeholders.
• Experience in CNS/psychiatry or related therapeutic areas is a plus; passion for Seaport’s patient-centric mission is essential.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. $198,000-$240,000. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is seeking a talented and experienced Program Leader (PL) to be an integrative cross-functional leader who is responsible for driving the GlyphAllo Program in order to maximize its future clinical and commercial success in the treatment of depression. This is a highly visible leadership role that bridges scientific, clinical, operational, and commercial disciplines. The GlyphAllo program is currently enrolling a Phase 2b study and the PL will lead the program to execute the current plans within timelines/budget and to plan for future pivotal clinical studies, initial global regulatory filings and pre-commercial activities. He/she will provide leadership across the spectrum of drug development and pre-commercialization activities, ensuring achievement of program and corporate goals. The ideal candidate will be a strategic and entrepreneurial leader well-versed in drug development and commercialization, and a strong influencer who can integrate multiple perspectives effectively and align stakeholders across different functions and levels of the organization.

This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 4 days per week to foster collaboration and effective leadership as the GlyphAllo program grows in complexity and importance. 

Summary of Key Responsibilities

· Serve as the overall program lead, accountable for end-to-end planning, execution, and delivery of key milestones of clinical studies through NDA submission.

· Work collaboratively and cross-functionally with Research, Nonclinical Development, Clinical Operations, Clinical Research, Regulatory Affairs, Medical Affairs, Manufacturing, Quality Assurance, Drug Safety & Pharmacovigilance, Program Management, Distribution & Supply, Commercial and Finance to deliver on program goals within established timelines and budget.

· Partner closely with Program Management to drive alignment and execution across the cross-functional program team, including development and maintenance of integrated, cross-functional strategic plans, timelines, and budgets; proactive identification of risks; and implementation of mitigation strategies.

· Oversee the development of market research plans to gather deep insights from patients, providers, payers, and other stakeholders. Integrate the insights and other market competitive intelligence into program strategies.

· Integrate cross-functional perspectives, ensuring that program strategy is informed by scientific evidence, clinical data, and the evolving competitive landscape. On an ongoing basis, proactively anticipate issues and ensure contingency plans are put in place; identify barriers and identify solutions to mitigate them; identify opportunities and strategies to capitalize on them.

· Working with functional leaders, ensure that appropriate prioritization and adequate resource allocation (financial and personnel) are present to meet the program timelines and deliverables.

· Maintain a high performing cross-functional program team, monitoring program resourcing, managing conflict, and building team culture; create a positive atmosphere to get the most out of the team.

· Serve as an internal and external ambassador for the program, fostering broad engagement to cultivate strategic KOL relationships and enabling overall integration of external insights to inform program strategies.

· Summarize and represent the program to Seaport leadership, Board of Directors, collaborators, and other external parties, as requested.

Qualifications

· BA/BS degree required; advanced medical, scientific or business degree strongly preferred.

· 10+ years biopharmaceutical development and commercialization experience, with previous demonstrated program leadership responsibilities; demonstrated experience leading cross-functional teams in drug development and pre-commercialization.

· Deep understanding of drug development and global product registration is required, ideally in neuropsychiatry (with preference for experience in depression or anxiety). Commercialization and /or Medical Affairs experience considered a strong plus. Leadership of a recent successful program (positive pivotal data, regulatory approval, etc.) would be ideal.

· Proactive “hands-on” individual with collaborative orientation, who manages teams effectively, is very self-motivated and can smoothly establish strong working relationships within both internal and external organizations. Entrepreneurial problem solver. Achieves goals within timelines and budgets while anticipating and navigating obstacles effectively.

· Initiative and independence to identify short and long-term program needs, creatively formulate plans with team input, efficiently achieve timely decisions/alignment, and organize and deploy resources.

· Exceptional written and verbal communication skills; able to articulate program vision and motivate the team; communicates in an open, direct and timely manner; ensures broader organization is aligned with and aware of the program strategy, status and risks.

· Motivated by patient focus and personal commitment to high performance and results.

· Possesses high integrity and exceptional work ethic.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $275,000-$310,000 with the final offer based on experience, market data, and internal equity.

We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Role Overview 

The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications 

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Successful track record of translation and implementation of clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities. 
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $265,000 - $300,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.