Executive Director, Medical Safety Strategy and Benefit Risk Management

Insmed Incorporated

53d • $306,000 - $417,000 • Remote

About The Position

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.

Requirements

• MD or foreign equivalent
• Significant experience in Global Pharmacovigilance with proven understanding of global PV regulations, GVP requirements, and relevant ICH guidelines.
• 10+ years of experience in drug development within a biotech or pharmaceutical company, including a minimum of 8 years in a safety-related position.
• 4+ years of postdoctoral clinical experience in a hospital or academic setting.
• Ability to influence and drive organizational changes, especially in the context of building new capabilities, streamlining safety processes, or implementing innovative technologies.
• Experience operating in a global role with cross-cultural awareness and the ability to lead and collaborate with teams across multiple time zones and regions.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
• Experience in leading roles in clinical or safety through complete submission process.
• Strong leadership capabilities with a track record of coaching, mentoring, and fostering high performing collaborative teamwork.
• Proven skills in presenting clinical and safety data to global health authorities with experience in regulatory meetings and safety related discussions.

Nice To Haves

• Specialty board certification.
• Advanced training in Pharmaceutical Medicine, Epidemiology, or Public Health (e.g., MPH, MSc, PhD or equivalent experience) strongly preferred.

Responsibilities

• 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.
• 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 safety-related deliverables.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree