Associate Director, Translational Medicine and Nonclinical Development

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

Job summary

BlueRock Therapeutics, a Bayer subsidiary, is advancing a career as Associate Director, Translational Medicine (TMND) in Cambridge, MA. You will lead biomarker endpoints across CNS, ophthalmology, and inflammatory areas, partnering with cross-functional teams to drive clinical development and regulatory strategies.

You will manage biomarker programs in early clinical stages, oversee CRO vendors, and collaborate with biostatistics to interpret data, shaping the next steps inBlueRock’s development

Qualifications

• PhD in Biology or related discipline with industry experience.
• Experience with biomarker endpoints in early-stage CNS/ophthalmic/inflammatory diseases a plus.

Responsibilities

• Develop translational biomarker strategies to support clinical plans and regulatory path.
• Coordinate with Research to characterize novel biomarker endpoints in preclinical studies.
• Develop and validate biomarker methods for clinical use.
• Support clinical biomarker implementation in trials.
• Work with Biostats and Modeling to ensure biomarker-driven decisions.
• Collaborate with Clinical Development and TMND to interpret results and define next steps.
• Oversee CRO vendors to ensure timely biomarker projects across US and Europe.
• Assist Business Development in diligence efforts as needed.

Skills

Biomarker endpoints

Translational medicine

Cross-functional collaboration

Clinical development

Education

PhD in Biology

Tools

CRO management

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.

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

As a critical member of the team, the Associate Director of TMND will leverage their expertise to:

• 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.

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.

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.