Director, Medical Safety Lead - DSPV, Gene Therapy

About the role

We're seeking a Director, Medical Safety Lead - DSPV Gene Therapy to help expand possibilities for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, this role involves maintaining deep knowledge of the product portfolio and associated safety profiles, conducting safety signal detection, and providing expert support to both internal and external stakeholders.

Responsibilities

• Review safety data from various sources throughout the development process and post-marketing for assigned products and development compounds.
• Conduct safety signal detection activities, monitor, evaluate, interpret, and manage safety information.
• Lead the Safety Review Team(s) for assigned products and development compounds, managing ongoing assessments of benefit-risk profiles and related actions.
• 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, CTAs.
• Develop and implement safety and benefit-risk management strategies for assigned products, developing key content of Risk Management documents (RMPs, REMS).
• Write and update periodic reports for assigned products, providing medical interpretation, review, and approval for required reports.
• Share DSPV and medical expertise with global counterparts in other functional areas, such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Provide expert safety input to the clinical development program for assigned products and development compounds.
• Ensure accurate representation and communication of the safety profile of assigned products and development compounds through regulatory documents and labeling.
• Respond to inquiries from regulatory authorities on safety issues.

Requirements

• An MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products.
• Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information.
• Knowledge and understanding of national & international Pharmacovigilance and regulatory guidelines.
• Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.
• Impeccable communication skills, both verbal and written.
• Excellent organizational skills with a strong attention to detail, clarity, accuracy, and conciseness.
• Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace.

Qualifications

• Master of Public Health (MPH) is a plus.
• 2+ years’ experience in Clinical Patient Care is strongly preferred.
• Drug safety database knowledge is preferred.
• Experience working on gene therapy products is a plus.
• Product defense before a national or international regulatory authority is a plus.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. Our 401(k) plan includes a competitive company match, and we offer annual equity awards and participation in our Employee Stock Purchase Plan (ESPP), along with company-paid life and disability insurance. We also provide access to our Employee Learning Institute, which includes LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities. We have multiple employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$247,000.00 - $337,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events may be expected. Travel requirements: Up to 20% domestic travel.