Senior Medical Director, Clinical Safety
Cambridge, Massachusetts, United States of America
Full Time
4 hours ago
$310,000 - $365,800 USD
Visa Sponsor
Key skills
Statistical Analysis
About this role
Role Overview
- 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
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
- Genuine interest in cell and gene therapy, rare disease, or neuroscience a strong plus
Benefits
- Hybrid or in-person arrangements available