Senior Medical Director, Clinical Safety

BlueRock Therapeutics

Clinical Safety Physician leading safety assessments for clinical trials at BlueRock Therapeutics. Collaborating with regulatory teams and overseeing safety operations for clinical drug development.

Posted 6/12/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $310,000 - $365,800 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Hybrid or in-person arrangements available

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical assessmentcausality determinationsbenefit-risk evaluationsafety signal detectionaggregate safety reviewSAE narrativesmedical codingsignal detectionbenefit-risk documentationclinical trial safety operations

Soft Skills

clear communicationdirect communicationstrong written skillsstrong verbal skillsengagement with investigatorsengagement with regulatory authoritiescollaborationleadershiporganizational skillsadaptability

Certifications

MDclinical training