Senior Director, Safety Science

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.

• 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.

• 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…