Associate Director, Translational Medicine and Nonclinical Development

BlueRock Therapeutics LP; Cambridge (MA); On-site; USD 181,000 - 192,000; Full time

Job summary

BlueRock Therapeutics LP in Cambridge, MA is seeking an Associate Director, Translational Medicine (TMND) to lead biomarker endpoints across multiple development programs. You will manage biomarker strategies and work with internal teams and CROs to drive translational science.

The role leverages CNS and ophthalmology expertise to advance the company’s pipeline, with oversight of biomarker methods, data interpretation, and regulatory alignment.

Qualifications

• Ph.D. in Biology or related discipline with at least 4 years of industry experience.
• Experience with biomarker endpoints for early-stage clinical development in CNS, ophthalmic and inflammatory diseases is desired.
• Background in immunology is highly desirable.

Responsibilities

• Develop translational biomarker strategies to support clinical development plans, regulatory path, and product commercialization.
• Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies.
• Develop biomarker methods and analytically validate biomarkers for clinical use.
• Support the implementation of clinical biomarkers in clinical trials.
• Collaborate with Biostats and Modeling to ensure biomarker-driven decision-making across all drug development phases.
• Work with Clinical Development, TMND and cross-functional teams to report biomarker results and interpret next steps.
• Oversee CRO vendors ensuring biomarker projects run effectively in US, Europe and other regions.
• Provide support for Business Development on diligence efforts.

Skills

Biomarker endpoints

Clinical development

CNS / ophthalmic disease experience

Immunology background

Education

Ph.D. in Biology or related discipline

Job description

BlueRock 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+GENE™ 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 leading engineered cell therapy company using its unique CELL+GENE™ platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel CELL+GENE™ platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of Position: It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients’ lives across multiple disease areas. The Associate Director, TMND, will be expected to take on a highly visible role with internal and external stakeholders through the management of biomarker endpoints, including digital health readouts, leveraged in BlueRock’s clinical development programs. The Associate Director of Translational Medicine will leverage their expertise across multiple therapeutic areas including neurology and ophthalmology to advance the company’s development pipeline by working closely with program leads and other subject matter experts. The position will be based in Cambridge, Massachusetts.

Responsibilities

• Develop translational biomarker strategies designed to support clinical development plans, the regulatory path, and product commercialization.
• Partner with Research to discover and characterize novel biomarker endpoints in preclinical studies.
• Develop biomarker methods and analytically validate biomarkers for clinical use.
• Support the implementation of clinical biomarkers in clinical trials.
• Partner with Biostats and Modeling and Simulations to ensure biomarker-driven decision-making across all phases of drug development.
• Partner with Clinical Development, TMND, and other cross-functional teams to report biomarker results and drive interpretation and next steps.
• Oversee CRO vendor/partners ensuring that they optimally execute clinical and preclinical biomarker projects in the US, Europe and other key geographic regions of interest.
• Provide support for the Business Development organizations as needed on diligence efforts.

Minimum Requirements

• Ph.D. in Biology or related discipline with at least 4 years of industry experience.
• Specific experience with biomarker endpoints for early-stage clinical development in CNS, ophthalmic and inflammatory diseases is desired.
• Background in immunology highly desired.

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.

The estimated compensation range for this position is $ 181,000.00 - $ 192,060.00 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.

BlueRock Therapeutics is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, one for the treatment of Parkinson’s disease and one for the treatment of primary photoreceptor diseases, are clinical stage programs.

BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.