Job Description

Our client's Pharmacovigilance and Drug Safety department is expanding rapidly, offering an exceptional opportunity for a Medical Director/Senior Medical Director, Pharmacovigilance specialized in Pharmacovigilance and Risk Management. Situated in Cambridge, MA, and reporting directly to the SVP of Clinical Development, this role is at the core of our clinical development efforts, with four product candidates poised for significant milestones, including two phase III studies for registration in 2024.

As the Medical Director/Senior Medical Director, Pharmacovigilance, you will lead the pharmacovigilance strategy pharmacovigilance strategy, providing crucial medical expertise across the company's clinical portfolio. In this position you will influence the direction of our pharmacovigilance strategies and ensure the highest level of drug safety and patient care within our clinical trials and future product launches.

KEY RESPONSIBILITES

• Directing safety assessments, signal detection, risk management, and benefit-risk strategies for assigned products.
• Medical review of serious adverse events (SAEs) and providing medical assessments of individual cases.
• Leading cross-functional Safety Management Team meetings and contributing to the preparation and review of periodic safety reports.
• Participating in the creation of study-specific documents, such as clinical trial protocols and Investigator’s Brochures.
• Providing safety inputs for regulatory filings and contributing to document preparation for health authorities.
• Leading the development of safety-related responses to queries from health authorities, institutional review boards (IRBs), and other regulatory bodies.
• Serving as the medical safety lead and advisor for assigned products, representing the department in cross-functional and departmental meetings.
• Guiding pharmacovigilance and risk management decisions and ensuring effective communication within and outside the company.
• Managing resource needs and timelines to maintain regulatory compliance.
• Contributing to scientific publications and evaluations of new business development opportunities.

KEY REQUIREMENTS

• M.D. or M.D., Ph.D
• 4 or more years of experience in the pharmaceutical industry and at least 3 years in Pharmacovigilance. Oncology or immuno-oncology experience is preferred.
• Completion of a U.S. medical residency or equivalent international experience.
• Familiarity with FDA and EMA regulatory processes and guidelines; experience with global Regulatory Authorities.
• Experience in designing, running, and analyzing clinical studies, preferably with biologics.
• Knowledge of translational medicine, clinical pharmacology, and early-stage development in PV and risk management strategies.
• Proficiency in clinical research concepts, practices, GCP, and ICH guidelines.

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