Senior Medical Director, Clinical Safety

## Senior Medical Director, Clinical Safety Apply remote type:
OnSitelocations:
MA-Cambridge time type:
Full time posted on:
Posted 11 Days Agojob requisition :
JR3

Blue Rock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENETM platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.
Founded in 2016, Blue Rock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.
What Are We Doing?
Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.
We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.
** Who is Blue Rock?
** Blue Rock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a pioneering engineered cell therapy company. Using our proprietary CELL+GENETM 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 Blue Rock’s medical safety lead across our clinical portfolio.

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 Blue Rock’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 Blue Rock’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 Blue Rock’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 Blue Rock 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…