Executive Director, Medical Safety Strategy and Benefit Risk Management

Executive Director, Global Medical Safety Strategy

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.

The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and marketed products while spearheading the integration of new technology and processes to enhance patient safety and benefit risk management. The ED will provide day-to-day leadership and guidance to the Medical Safety Strategy and Benefit-Risk Management group within DSPV to ensure timely delivery of high priority tasks in accordance with all relevant company and regulatory policies and procedures. This role also oversees global safety and risk management activities for Insmed's portfolio with a focus on proactive signal detection, signal management, and benefit-risk evaluations ensuring strategic alignment throughout the product's lifecycle. This position reports to the VP, DSPV and may serve as delegate during his absence.

What You'll Do :

• Lead the DSPV Medical Safety Strategy and Benefit-Risk Management group providing strategic direction, oversight and leadership across all activities including the ongoing and cross functional assessment of benefit risk profiles for development compounds and marketed products.
• Provide high level strategic consultation and subject matter expertise on decisions with significant safety impact including safety signal detection, evaluation, validation, escalation, and communication for Insmed's portfolio.
• Ensure effective monitoring and proactive management of medical safety deliverables.
• Provide medical review, scientific content input, and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee.
• Provide strategic leadership in the advancement of global medical safety operations in alignment with strategic safety objectives and operational excellence functions.
• Provide medical expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, and CTAs ensuring safety content is clear, accurate, and compliant.
• Lead the analysis and interpretation of safety data for inclusion in regulatory submissions and marketing applications in partnership with Clinical Development and other relevant functions. This includes NDA / MAA safety sections, reference safety information (i.e, CCDS), PSUR / PBRER, DSUR, as well as scientific publications, abstracts, and presentation materials.
• Lead the development and ongoing review of Risk Management Plans (RMPs), Risk-Evaluation and Mitigation Strategies (REMS), and other PV tools that support Regulatory Compliance and patient safety.
• Responsible for the preparation of responses to safety-related inquiries from regulatory authorities; provide guidance and final review of submissions authored by other Medical Safety Leads.
• Develop, track, and report on critical metrics and quality indicators, identifying trends and implementing corrective and preventative actions.
• Oversee medical safety and pharmacovigilance activities conducted with external partners including contract research organizations (CROs) and vendors. Assist with the selection, oversight and monitoring of these partners to ensure compliance with company policies, regulatory requirements, and timely completion of safety-related deliverables.
• Ensure the Medical Safety Strategy and Benefit-Risk Management group maintains a constant state of audit and inspection readiness.
• Support in planning, prioritizing, and managing budgets for the DSPV function to align with corporate objectives and changing business needs.
• Establish and track safety objectives and manage team performance through regular feedback, development planning, and performance evaluations to drive accountability and excellence.
• Participate in building the talent pipeline for key roles within the department. Contribute to succession planning and team development by identify