Vice President and Global Head of Drug Safety and Pharmacovigilance

What You'll Do

Set strategic direction for the global DSPV organization and develop & execute a multi-year PV roadmap aligned with Insmed's pipeline and commercial growth.

Strategic Leadership

• Lead enterprise transformation programs, including a current strategic initiative, ensuring stakeholder alignment and full implementation.
• Attract, develop, and retain top PV talent to build a high-performing, globally diverse team.
• Represent Insmed externally at regulatory forums, industry associations, and scientific conferences.

Safety Science & Medical Oversight

• Oversee global safety surveillance, signal detection, and risk management for all Insmed products.
• Ensure timely, high-quality medical safety deliverables and benefit-risk communications aligned with FDA, EMA, and PMDA frameworks.
• Champion integration of AI/ML, advanced analytics, and real-world evidence into PV workflows.
• Maintain deep expertise in rare disease safety science, including small patient population signal detection.

Global Regulatory Compliance

• Ensure compliance with global PV regulations (GCP, GVP, GMP, ICH) across all markets; maintain inspection readiness.
• Support the EU/UK QPPV and oversee EMEA and Japan PV operations.
• Lead REMS and global Risk Management Plan (RMP) development and negotiation.
• Represent DSPV in interactions with FDA, EMA, PMDA, and other health authorities.

Operational Excellence & Digital Innovation

• Drive implementation of an enterprise-wide strategic initiative, including PV system modernization and global workflow standardization.
• Govern a PV Technology and Innovation roadmap; evaluate and implement next-generation safety platforms and AI-assisted tools.
• Develop and track DSPV KPIs and quality metrics; manage global PV budget and vendor ecosystem.
• Ensure business continuity for all critical PV processes.

Cross-Functional & External Engagement

• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, Quality, and Legal/Compliance.
• Serve as executive sponsor and cross-functional liaison for the enterprise-wide strategic initiative.
• Engage with patient advocacy organizations, rare disease consortia, and industry working groups (DIA, ISOP, BIO, EFPIA).

Who You Are

You must have an MD with 15+ years of drug development experience within a pharmaceutical or biotech company, 10+ years of pharmacovigilance (PV)/drug safety leadership, and a minimum of 5 years' experience as a VP or equivalent with full PV organizational accountability.

• Demonstrated experience as the head of a global PV organization, with ownership of safety strategy, compliance, operations, and team performance.
• A proven track record building, scaling, and transforming PV organizations through periods of significant change.
• 4+ years post-doctoral clinical experience.
• FDA and EMA inspection leadership; experience as or supporting EU/UK QPPV.
• Experience leading large-scale PV transformation or technology modernization programs and familiarity with AI/ML applications in pharmacovigilance.
• Experience with BLA/NDA/MAA/JNDA submissions and health authority interactions (FDA, EMA, PMDA).
• Exceptional executive leadership ability to inspire, coach, and develop globally distributed teams.
• Proven ability to lead through influence; demonstrated executive gravitas and leadership presence.
• Strong negotiation, conflict management, and cross-functional collaboration skills.
• Financial acumen to drive global budget management, vendor governance, and KPI development.
• Excellent communication; able to present complex safety data to Boards, health authorities, and senior leadership.
• Proficiency in PV databases (ARISg, Oracle Argus, Veeva Vault Safety), MedDRA coding, and Microsoft Office Suite.
• A commitment to inclusive leadership and diverse, equitable team building.

Nice to have (but not required)

• Specialty Board Certification.
• An advanced degree, in addition to an MD, in Pharmaceutical Medicine, Epidemiology/Public Health, or Regulatory Science is strongly preferred.
• Rare disease experience is strongly preferred.