Senior Medical Director, Clinical Safety
About The Position
BlueRock Therapeutics is seeking a Senior Medical Director, Clinical Safety. This is a pivotal, highly visible role for a clinician-scientist who wants to do meaningful safety work at the frontier of cell therapy, not just maintain a system, but help build one. Reporting directly to the Chief Medical Officer and embedded within the Development leadership team, the Clinical Safety Physician will serve as BlueRock’s medical safety lead across our clinical portfolio. The title and level (Senior Director or VP) will be calibrated to experience. What matters most is clinical judgment, a collaborative mindset, and the appetite to shape something from the ground up in a lean, science-driven environment.
Requirements
- MD (or equivalent) required. active clinical training or clinical medicine background highly valued
- Meaningful (5+ years) pharmaceutical/biotech industry experience in drug safety and pharmacovigilance, with direct experience in clinical trial safety operations and medical review
- Strong working knowledge of FDA and EMA safety regulations; familiarity with ICH E2 guidelines and global IND/CTA safety reporting requirements
- Hands-on experience with SAE narratives, medical coding (MedDRA), signal detection, and benefit-risk documentation
- Comfortable operating in a lean, matrixed environment- a builder, not just a maintainer
- Clear, direct communicator with strong written and verbal skills; able to engage credibly with investigators, regulatory authorities, and cross-functional colleagues
Nice To Haves
- Genuine interest in cell and gene therapy, rare disease, or neuroscience a strong plus
Responsibilities
- Serve as the medical safety lead and subject matter expert across BlueRock’s clinical trial portfolio, providing hands-on safety review and medical oversight of all ongoing studies
- Lead SAE/SUSAR medical assessment, causality determinations, and benefit-risk evaluation in close partnership with Clinical Development and Regulatory Affairs
- Own safety signal detection and management, including aggregate safety review and signal tracking across programs
- Drive preparation and medical review of safety sections for protocols, statistical analysis plans, clinical study reports, IND/CTA submissions, and periodic aggregate reports (DSURs, PBRERs)
- Develop and maintain BlueRock’s Core Safety Information and reference safety information
- Oversee safety vendor selection, management, and deliverable quality for PV operations
- Ensure global safety reporting compliance and maintain inspection readiness
- Contribute to the evolution and growth of BlueRock’s Safety and PV organization as the pipeline expands
- Collaborate with our parent company Bayer and be the point of contact for the Safety/Pharmacovigilance team within Bayer
- Oversee safety operations and safety scientists on the BlueRock team
Benefits
- Hybrid or in-person arrangements available
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
