Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)

Responsibilities:
- Develop, implement, and lead pharmacovigilance strategy for inflammatory and oncology programs across Phase I–III clinical development.
- Provide safety guidance on immune-mediated adverse events, cytokine-related toxicities, infection risk, malignancy risk, and oncology-specific safety concerns.
- Support dose-escalation and cohort-expansion decisions (including Dose Escalation Committees and Safety Review Committees).
- Maintain ongoing benefit-risk assessments based on disease severity, unmet need, and evolving data.
- Serve as primary safety partner to Clinical Development for protocol design, safety monitoring plans, stopping rules, and risk mitigation.
- Chair or actively participate in Safety Management Teams (SMTs), Joint Safety Forums, and other governance bodies.
- Identify emerging safety signals and ensure appropriate escalation through internal governance.
- Oversee intake, medical review, and regulatory submission of Individual Case Safety Reports (ICSRs).
- Ensure high-quality MedDRA coding, oncology-appropriate event characterization, and robust safety narratives; lead safety review meetings and follow-up of serious/immune-mediated adverse events.
- Oversee literature surveillance and safety data collection from investigators, sites, and vendors.
- Lead development and lifecycle management of RMPs, DSURs, and safety sections of IBs, protocols, ICFs, and clinical study reports.
- Provide safety input to IND/CTA submissions, amendments, and responses to health authority questions.
- Support aggregate safety analyses and signal detection relevant to oncology and inflammatory disease development.
- Build and maintain fit-for-purpose PV operations for a clinical-stage biotech; manage PV vendors/CROs.
- Define and maintain safety database strategy (e.g., Argus or equivalent) and scalability.
- Establish pragmatic KPIs/processes; ensure inspection readiness.
- Lead development/maintenance of PV SOPs, work instructions, and training.
- Partner with Quality and Regulatory to address safety findings, deviations, and corrective actions; collaborate with cross-functional teams (Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Medical Writing).

Qualifications:
- Bachelor’s degree in a scientific or healthcare-related discipline required.
- Advanced degree (MS, PharmD, PhD, MD, RN) strongly preferred.
- 12+ years of pharmacovigilance/drug safety experience in pharmaceutical/biotechnology settings.
- Direct experience supporting oncology (I/O) and/or inflammatory disease clinical programs.
- Experience with early-phase development, dose escalation, and complex safety decision-making.
- Prior involvement in safety governance and regulatory interactions during development.
- Strong knowledge of global PV regulations/guidelines (FDA, EMA, ICH, GCP).
- Experience with safety databases (Argus or equivalent).
- Deep understanding of immune-mediated and oncology-specific safety risks.
- Ability to operate strategically while remaining hands-on in a lean biotech environment.