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, and evolving clinical data.
- Serve as the primary safety partner to Clinical Development, contributing to protocol design, safety monitoring plans, stopping rules, and risk mitigation strategies.
- 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 safety governance pathways.
- 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 oversee follow‑up of serious and immune‑mediated adverse events.
- Oversee literature surveillance and safety data collection from investigators, sites, and vendors.
- Lead development and lifecycle management of development‑stage Risk Management Plans (RMPs), DSURs, and safety sections of IBs, protocols, ICFs, and clinical study reports.
- Provide safety input to regulatory submissions (IND/CTA), amendments, and responses to health authority questions.
- Support aggregate safety analyses and signal detection activities relevant to oncology and inflammatory disease development.
- Build and maintain fit‑for‑purpose pharmacovigilance operations suitable for a clinical‑stage biotech.
- Manage PV vendors and CROs supporting case processing, literature review, and safety reporting.
- Define and maintain safety database strategy (e.g., Argus or equivalent), ensuring scalability as programs advance.
- Establish pragmatic KPIs and processes aligned with development‑stage needs.
- Ensure inspection readiness for development‑stage regulatory inspections.
- Lead development and maintenance of PV SOPs, work instructions, and training programs.
- Partner with Quality and Regulatory teams to address safety findings, deviations, and corrective actions.
- Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing.
- Promote a culture of patient safety, scientific rigor, and informed risk‑taking appropriate for serious inflammatory and oncology indications.
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 or drug safety experience in pharmaceutical or 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 and 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.
