Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)
Monte Rosa Therapeutics, Boston, MA, United States
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.