Senior Medical Director, Clinical Safety
$310k - $328.5kJobleads-US
- # Senior Medical Director, Clinical SafetyApplyremote type: OnSitelocations: MA-Cambridgetime type: Full timeposted on: Posted 11 Days Agojob requisition id: JR3BlueRock 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, BlueRock 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 BlueRock?**BlueRock 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 BlueRock’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 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.***Equal Opportunity Workplace:** BlueRock welcomes and supports diversity in all its forms and is proud to be an equal opportunity employer. Please let us know if you require accommodation during the recruitment process.The estimated compensation range for this position is $ 310,000.00 - $ 328,500.00 per year.Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Vacancy posted 3 days ago
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