Insmed is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Guided by our patients-first mentality, we are building a diverse, inclusive, and collaborative culture where bold ideas are encouraged, and employees are empowered to make a difference.
Recognized as a Science’s Top Employer and a Great Place to Work® Certified company, Insmed has consistently been named one of the best workplaces in biopharma. Our team is passionate about innovation, integrity, and delivering life-changing therapies to patients worldwide.
Role Overview – Executive Director, Global Medical Safety Strategy
The Executive Director (ED), Global Medical Safety Strategy will lead safety and benefit-risk management across Insmed’s global portfolio of investigational and marketed products. Reporting to the VP of Drug Safety & Pharmacovigilance (DSPV), this senior leader will:
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Provide strategic oversight for medical safety and benefit-risk management.
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Spearhead integration of new technology and processes to enhance patient safety.
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Lead a high-performing team within DSPV, ensuring operational excellence, regulatory compliance, and proactive safety signal management.
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Partner cross-functionally to guide safety strategy throughout the full product lifecycle.
This is a global leadership role with direct impact on patient safety, regulatory strategy, and organizational growth.
Key Responsibilities
As the Executive Director of Global Medical Safety Strategy, you will:
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Lead & Strategize: Direct the DSPV Medical Safety Strategy and Benefit-Risk Management group, ensuring alignment with corporate and regulatory objectives.
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Signal Management: Oversee safety signal detection, validation, and escalation for all Insmed products.
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Regulatory Leadership: Provide expert safety input into INDs, NDAs, MAAs, CTAs, PSURs, PBRERs, DSURs, RMPs, REMS, and other regulatory submissions.
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Cross-Functional Collaboration: Partner with Clinical Development, Regulatory Affairs, and external partners to ensure accuracy, compliance, and clarity in safety documentation.
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Operational Excellence: Maintain audit readiness, develop safety KPIs, track metrics, and drive process improvements.
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Team Leadership: Recruit, coach, and develop top talent, fostering a culture of accountability, collaboration, and innovation.
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External Engagement: Represent Insmed with regulators, CROs, and key stakeholders, presenting clinical and safety data at a global level.
Qualifications & Experience
To be successful in this role, you should bring:
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Education: Medical Degree (MD or equivalent) required; board certification highly desirable. Advanced training (MPH, MSc, PhD in Pharmaceutical Medicine, Epidemiology, or Public Health) strongly preferred.
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Clinical Experience: 4+ years of postdoctoral clinical practice in hospital or academic settings.
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Industry Experience: 10+ years in biotech/pharma drug development, with at least 8 years in pharmacovigilance or safety-related leadership roles.
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Expertise: In-depth knowledge of global PV regulations, GVP requirements, and ICH guidelines.
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Leadership Skills: Proven ability to lead teams, influence stakeholders, and drive organizational change.
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Regulatory Experience: Strong track record of preparing and presenting safety data to global health authorities.
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Global Mindset: Cross-cultural awareness and ability to lead international teams.
Compensation & Benefits
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Salary Range (US): $319,000 – $382,600 annually
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Compensation Package: Competitive salary, annual bonus, equity awards, and ESPP.
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Health & Well-Being: Comprehensive health benefits and time-off plans.
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Flexibility: Hybrid and flexible work arrangements.
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Career Growth: Tuition reimbursement, leadership development, and global exposure.
Why Join Insmed?
At Insmed, we believe our employees are our greatest resource. Joining us means:
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Being part of a mission-driven biopharma company changing patients’ lives.
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Working in an award-winning workplace culture that values collaboration, passion, respect, and integrity.
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Gaining the opportunity to lead global safety strategy at a pivotal time of growth.
Equal Opportunity Employer
Insmed is proud to be an Equal Opportunity Employer, committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, religion, gender identity, age, disability, veteran status, or other protected characteristics.