Alpha Clinical Development

Position Summary: We are seeking an experienced and strategic Head of Drug Safety & Pharmacovigilance on behalf of our biopharmaceutical client based in the San Francisco Bay Area (US). The selected candidate will be responsible for leading the global safety strategy while ensuring hands‑on oversight of pharmacovigilance (PV) operations across a diverse biologics pipeline. This role requires deep expertise in oncology, along with exposure to metabolic and immunology safety, and the ability to support both development and commercial‑stage assets. This is a senior leadership role requiring strong regulatory knowledge, cross‑functional collaboration, and the ability to build and scale global PV capabilities.

Key Responsibilities

• Define and implement global pharmacovigilance and risk management strategies across oncology, metabolic, and immunology portfolios
• Oversee PV activities across Phase I–III clinical trials, including safety data review, SAE handling, and aggregate reporting (DSURs, PSURs, PADER, PBRER)
• Lead signal detection, risk mitigation, and benefit‑risk assessments for complex therapeutic profiles
• Manage safety sections for regulatory submissions (INDs, NDAs) and respond to FDA/EMA queries
• Ensure compliance with global PV regulations (21 CFR Part 312, ICH E2 guidelines, GVP, GMP)
• Represent the safety function in regulatory meetings, audits, and inspection readiness activities
• Oversee internal safety review processes and support DSMB coordination
• Collaborate cross‑functionally with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and CRO partners
• Lead and mentor a growing PV team and contribute to global safety operations and capability building

Qualification & Profile

• MD (preferred), PharmD, or PhD in Life Sciences
• 10+ years of experience in drug safety/pharmacovigilance
• 5+ years of leadership experience in a biopharmaceutical environment
• Strong oncology safety experience (ADCs, bispecifics, IO agents); exposure to metabolic/immunology is an advantage
• Proven experience with clinical trial safety and regulatory submissions (US/EU)
• Proficiency in safety databases (Argus, ArisG, Oracle)
• Strong understanding of signal detection, safety governance, and global PV regulations
• Excellent leadership, analytical, and communication skills
• Ability to manage cross‑functional teams across global time zones