Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)

Job description

Overview The Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline in inflammatory and oncology diseases . This role is responsible for establishing and executing global safety strategy across early‑ and mid‑stage clinical programs, with particular focus on immune‑mediated toxicities, oncology risk management, and complex benefit–risk assessment. The Director partners closely with Clinical Development and Regulatory teams to integrate safety considerations into study design, dose escalation, and development decisions. Responsibilities: - Develop, implement and lead pharmacovigilance strategy for inflammatory and oncology programs across Phase I–III clinical development. - Provide expert safety guidance related to immune‑mediated adverse events, cytokine‑related toxicities, infection risk, malignancy risk, and oncology‑specific safety concerns. - Support dose‑escalation and cohort‑expansion decisions, including participation in Dose Escalation Committees and Safety Review Committees. - Maintain ongoing benefit–risk assessments reflecting disease severity, unmet medical need...