Executive Director, Medical Safety Strategy and Benefit Risk Management

Role Summary

Executive Director, Medical Safety Strategy and Benefit Risk Management oversees Global Medical Safety Strategy for all investigational and marketed products, driving integration of new technology and processes to enhance patient safety and benefit-risk management. Leads the Medical Safety Strategy and Benefit-Risk Management group within DSPV to ensure timely delivery of high-priority tasks in compliance with company and regulatory policies. Oversees global safety and risk management activities with a focus on proactive signal detection, signal management, and benefit-risk evaluations across the product lifecycle.

Responsibilities

• Lead the DSPV Medical Safety Strategy and Benefit-Risk Management group, providing strategic direction and oversight across all activities including ongoing cross-functional assessment of benefit risk profiles for development compounds and marketed products.
• Provide high-level strategic consultation on decisions with significant safety impact, including safety signal detection, evaluation, validation, escalation, and communication for Insmed‚Äôs portfolio.
• Ensure effective monitoring and proactive management of medical safety deliverables.
• Provide medical review, scientific content input, and functional approval for safety documentation in collaboration with the Executive Safety Committee.
• Advance global medical safety operations in alignment with safety objectives and operational excellence functions.
• Provide medical expert safety input into critical documents for clinical development (protocols, amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs) ensuring safety content is clear, accurate, and compliant.
• Lead analysis and interpretation of safety data for regulatory submissions and marketing applications (NDA/MAA sections, reference safety information, PSUR/PBRER, DSUR, publications, abstracts, presentations).
• Lead development and review of Risk Management Plans (RMPs), REMS, and other PV tools supporting regulatory compliance and patient safety.
• Prepare responses to safety-related inquiries from regulatory authorities; guide and review submissions authored by other Medical Safety Leads.
• Develop, track, and report on critical metrics and quality indicators, identify trends, and implement corrective and preventative actions.
• Oversee medical safety and pharmacovigilance activities with external partners (CROs and vendors); select, oversee, and monitor partners to ensure compliance and timely safety deliverables.
• Maintain audit and inspection readiness for the Medical Safety Strategy and Benefit-Risk Management group.
• Plan, prioritize, and manage budgets for the DSPV function in alignment with corporate objectives.
• Establish safety objectives and manage team performance through feedback, development planning, and evaluations to drive accountability and excellence.
• Contribute to talent development and succession planning to grow future leaders within the department.
• Participate in cross-functional initiatives and enterprise-wide projects to support DSPV objectives and a culture of safety and continuous improvement.
• Perform additional responsibilities as needed to support business objectives.

Qualifications

• Medical degree (MD or equivalent) required; specialty board certification is highly desirable.
• Advanced training in Pharmaceutical Medicine, Epidemiology, or Public Health (e.g., MPH, MSc, PhD) strongly preferred.
• 4+ years of postdoctoral clinical experience in hospital or academic settings.
• 10+ years of drug development experience in biotech/pharmaceutical settings, including at least 8 years in a safety-related role.
• Ability to influence and drive organizational changes, build new capabilities, and implement innovative safety technologies.
• Experience operating in a global role with cross-cultural awareness and collaboration across time zones.
• Significant Global Pharmacovigilance experience with understanding of global PV regulations, GVP requirements, and ICH guidelines.
• Experience contributing to clinical safety assessments and regulatory submissions involving safety information.
• Experience in leadership roles across clinical or safety submission processes.
• Strong leadership with coaching, mentoring, and collaborative teamwork abilities.
• Proven ability to present clinical and safety data to global health authorities and participate in regulatory meetings.

Skills

• Strategic safety leadership
• Pharmacovigilance and regulatory affairs
• Risk management and safety data interpretation
• Cross-functional collaboration and stakeholder management
• Regulatory submissions and communication
• People leadership and talent development

Education

• Medical degree required; advanced degree in Pharmaceutical Medicine, Epidemiology, Public Health or related field preferred.

Additional Requirements

• Occasional travel as required for global operations and regulatory activities.