Executive Director, Medical Safety Strategy and Benefit Risk Management

Insmed Inc. • Bridgewater, NJ • 3h ago

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. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for an Executive Director to 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. Reporting to the VP, DSPV, the Executive Director 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.What You'll Do: In this role, you'll have the opportunity to 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. You'll also: 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. Be 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 safe

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