Senior Director, Safety Science

Generate:Biomedicines; Somerville (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

Generate:Biomedicines is seeking a Senior Director of Safety Science to provide strategic leadership across its clinical-stage portfolio. This role requires a deep understanding of pharmacovigilance and strong clinical judgment, influencing stakeholders without direct authority.

The ideal candidate will have significant experience in drug safety, overseeing safety governance activities, and contributing to regulatory submissions. This position offers the opportunity to shape safety standards and operational excellence.

Qualifications

• Minimum of 12 years of experience in drug safety/pharmacovigilance.
• Strong experience supporting products across multiple stages of development.
• Demonstrated ability to operate with broad autonomy and prioritize.

Responsibilities

• Provide strategic leadership for safety science across assigned development programs.
• Shape the safety strategy for products in clinical development.
• Drive high-quality interpretation of safety data from multiple sources.

Skills

Clinical judgment

Influencing stakeholders

Signal detection

Pharmacovigilance regulations knowledge

Education

MD, DO or equivalent

Formal training in patient care

Tools

Argus

Veeva Safety

Spotfire

Job description

Role

The Senior Director, Safety Science will serve as a senior individual contributor providing strategic safety science leadership across Generate’s clinical-stage portfolio. This role will help shape the future capabilities, standards, and operating model of the pharmacovigilance function while remaining an individual contributor without formal people management responsibilities. This position is designed for a highly experienced safety leader who can operate with broad autonomy, influence senior cross‑functional stakeholders, and drive an integrated, proactive, and scientifically rigorous approach to signal detection, aggregate safety assessment, benefit‑risk evaluation, and safety governance across development programs.

Key Contributions

• Provide strategic leadership for safety science across assigned development programs, with accountability for integrated safety surveillance, signal detection, signal assessment, aggregate review, and benefit‑risk evaluation.
• Shape the safety strategy for products advancing from early‑to‑late‑phase clinical development, ensuring alignment with program objectives, regulatory expectations, and long‑term portfolio needs.
• Lead cross‑functional safety governance, including Safety Management Teams and other safety review forums, ensuring robust decision‑making, clear documentation, and effective escalation of key risks.
• Drive high‑quality interpretation of safety data from multiple sources, including individual case reports, aggregate datasets, clinical studies, literature, and external data sources.
• Provide senior oversight and scientific direction for individual case review processes, analysis of similar events, signal tracking, and escalation pathways, partnering closely with internal stakeholders and external vendors.
• Oversee the preparation and strategic quality of core safety deliverables, including DSURs and other aggregate reports, Reference Safety Information, safety sections of Investigator Brochures, protocols, informed consent forms, clinical study reports, regulatory responses, and other key documents.
• Represent Safety Science on cross‑functional program teams and in interactions with external partners and regulatory authorities, ensuring safety perspectives are clearly articulated and incorporated into development plans.
• Partner with Clinical Development and Regulatory leaders to support health authority interactions, inspection readiness activities, and submission‑related safety strategies, including support for future NDA, BLA, or other major regulatory milestones.
• Build and continuously improve pharmacovigilance processes, governance, SOPs, standards, and tools to enable scalability, inspection readiness, and operational excellence.
• Act as a senior technical leader and trusted advisor within Safety and across the broader organization, raising the bar for scientific rigor, decision quality, and cross‑functional alignment.
• Lead oversight of CROs and safety service providers, establishing clear expectations, monitoring performance, and ensuring delivery against quality, compliance, and timeline commitments.
• Evaluate and implement fit‑for‑purpose systems, analytics, and digital capabilities that strengthen signal detection, reporting, data visibility, and organizational scalability.
• Influence portfolio‑ and function‑level decisions by translating complex safety data into clear recommendations for senior leadership and cross‑functional stakeholders.
• Identify emerging risks, dependencies, and resource needs across programs, and proactively drive mitigation plans that protect patients, studies, timelines, and company objectives.
• Serve as a recognized internal expert in clinical safety science and contribute externally, as appropriate, through regulatory engagement, scientific exchange, and thought leadership in the field.
• Mentor colleagues, share expertise generously, and help strengthen functional capability across the organization without formal people management responsibility.

Ideal Candidate

• MD, DO or equivalent with formal training and experience in patient care and clinical decision‑making.
• Minimum of 12 years of experience in drug safety/pharmacovigilance within clinical development, including at least 6 years in safety science roles with strategic responsibility for clinical‑stage assets.
• Demonstrated experience serving as the senior safety science lead for one or more clinical programs, with accountability for signal detection, aggregate review, benefit‑risk assessment, and safety input into development strategy.
• Strong experience supporting products across multiple stages of development, ideally including assets transitioning from early‑to‑late‑phase clinical development.
• Deep knowledge of global pharmacovigilance regulations, ICH guidelines, signal detection practices, aggregate reporting requirements, and benefit‑risk assessment.
• Strong clinical judgment and a demonstrated ability to interpret, synthesize, and communicate complex safety and clinical data to both technical and non‑technical audiences.
• Track record of influencing cross‑functional and senior stakeholders on complex safety issues, including the ability to drive alignment and decision‑making without direct authority.
• Experience leading or chairing safety governance activities and representing Safety Science on program teams and other cross‑functional forums.
• Experience with regulatory authority interactions, inspection readiness, and major submission support activities; direct experience supporting NDA, BLA, or MAA activities is strongly preferred.
• Experience overseeing CROs, vendors, and external partners, with strong command of quality, compliance, deliverable oversight, and issue escalation.
• Demonstrated ability to operate with broad autonomy, prioritize across competing demands, and bring strategic perspective in a fast‑paced, evolving biotech environment.
• Familiarity with safety databases and analytics platforms such as Argus, Veeva Safety, Spotfire, or related tools.
• Working knowledge of MedDRA, Standardized MedDRA Queries, analysis of similar events, and other core pharmacovigilance methodologies.
• Experience in biologics, translational safety, or emerging therapeutic modalities is a plus.
• Recognized subject matter expertise in safety science, with the credibility to mentor colleagues, shape functional standards, and represent the function internally and externally as appropriate.

Who Will Love This Job

• Senior individual contributors who want to operate with broad scope, high accountability, and meaningful influence across a growing development portfolio.
• People who can move fluidly between enterprise strategy and execution, bringing both judgment and action to ambiguous, high‑growth environments.
• Individuals who value accountability, candid collaboration, and continuous learning, and who elevate others through expertise, partnership, and influence.
• Builders who are excited to shape strategy, standards, and long‑term functional capability without formal people management.

Equal Employment Opportunity Statement

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.