Senior Medical Director, Clinical Safety

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a pioneering engineered cell therapy company. Using our proprietary CELL+GENE™ platform, we are developing a new generation of allogeneic cellular medicines for patients with neurological and ophthalmologic diseases, conditions where current therapies fall far short.

 

We are at an inflection point. With our lead neurology program (bemdaneprocel) advancing in Parkinson’s disease, an active inherited retinal disease program, and a deep pipeline moving toward IND and beyond, we are building the clinical infrastructure to match our scientific ambitions. Cambridge is our Development hub and we’re building a world-class team here.

The Opportunity

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.

What You’ll Do

• 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

What You Bring

• 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

Why BlueRock, Why Now

Cambridge’s biotech community is one of the most dynamic in the world, and BlueRock occupies a distinctive niche within it: a company with the scientific daring of a startup and the financial backing of a global pharmaceutical enterprise. You’ll work alongside a small, deeply experienced Development team on programs that have no real precedent, allogeneic iPSC-derived cell therapies in Parkinson’s disease, inherited retinal disease, and beyond.

 

This role offers direct access to leadership, meaningful influence over how safety is practiced at a growing cell therapy company, and the opportunity to be part of clinical programs that, if they work, will fundamentally change how we treat neurodegenerative disease.

 

Hybrid or in-person arrangements available, based in Cambridge, MA.