Lead medical safety strategy for investigational and marketed therapies in rare neuromuscular disease, with a focus on signal detection, risk management, and benefit-risk assessment across the product lifecycle. The role reviews safety data from preclinical, clinical, post-marketing, and literature sources, and supports regulatory submissions and responses. It is a cross-functional, highly collaborative leadership position that works closely with clinical development, safety scientists, CROs, and internal committees.
Key Responsibilities
- Lead pharmacovigilance strategy and safety planning for assigned products.
- Conduct signal detection, evaluation, interpretation, and communication of safety information.
- Provide medical safety review and causality assessment across preclinical, clinical, post-marketing, and literature data.
- Support risk-benefit evaluations through Product Safety Committee meetings and executive escalations.
- Review and contribute to critical development documents, including protocols, amendments, ICFs, IBs, CSR, and IND/NDA/BLA materials.
- Oversee aggregate reports and signal evaluation reports for assigned programs.
- Respond to safety-related inquiries from regulatory authorities.
- Coordinate with CROs, vendors, internal safety scientists, and cross-functional teams to support program delivery.
- Contribute to SOP development, process improvement, and departmental training.
Required
- MD, MBBS, MD-PhD, or equivalent medical degree.
- At least 5 years of pharmaceutical experience in drug safety and pharmacovigilance.
- Strong understanding of U.S. and EU pharmacovigilance regulations.
- Experience supporting drug safety activities in registrational clinical studies.
- Experience with drug development from discovery through registration and post-marketing surveillance.
Preferred
- Prior IND and NDA/BLA filing or submission experience.
- Prior regulatory interaction experience.
- Experience leading in a matrixed organization.
- Experience working with external vendors or CROs.
Benefits & Perks
- Salary range of $280,000 to $420,000.
- Opportunity to work on innovative therapies for rare neuromuscular diseases.
- Cross-functional leadership role with exposure to clinical development and regulatory strategy.
- Equal opportunity, inclusive workplace environment.