Director, Medical Safety Lead - DSPV, Gene Therapy

What You'll Do

• Review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds.
• Conduct safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of 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).
• Work with the DSPV leadership to 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.
• Provide input into the writing of periodic reports for assigned products; provide 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, 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, thorough assessment 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.

Who You Are

You must have 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.

Nice to have (but not required)

• 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 a plus.