Director, Medical Safety Lead - DSPV, Gene Therapy

About the role

We're seeking a Director, Medical Safety Lead - DSPV Gene Therapy to join our team. 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 activities, and collaborating on labeling updates.

Responsibilities

• Review all 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 appropriately manage and communicate safety information.
• Lead the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross-functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents.
• Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products.
• 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, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of assigned products and development compounds.
• Provide integrated safety input into all regulatory documents, conduct thorough assessments of safety profiles for Due Diligence projects, and provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters.
• 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

• Nice to have (but not required): Master of Public Health (MPH), 2+ years’ experience in Clinical Patient Care, Drug safety database knowledge, experience working on gene therapy products, and experience working on safety issues before a national or international regulatory authority.

Skills

• Expertise in pharmacovigilance and regulatory guidelines.
• Strong communication and presentation skills.
• Ability to manage multiple projects and deadlines.
• Attention to detail and accuracy.

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. Additionally, we offer a 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.

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.