About this role
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 is a leading engineered cell therapy company using its unique CELL+GENE TM platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from ophthalmological, 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 four therapeutic areas: ophthalmology, 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. BlueRock is recruiting a key field-based member of the Clinical Development group to support clinical trial activities and direct surgical training and operating room oversight for the ophthalmology programs.
The Clinical Trial & Surgical Science Liaison (CTSSL) will serve as: a value-added resource and extension of BlueRock Therapeutics supporting BlueRock’s Ophthalmology clinical trial pipeline, and the primary BlueRock representative within operating rooms during ophthalmic surgery. The CTSSL will serve as a clinical trial and clinical program subject matter expert and problem solver to help study sites optimize their study performance. The CTSSL will work full time to help sites address challenges in study delivery that could impact BlueRock’s study or program goals.
This role involves compliant collaboration with KOLs, investigators, research staff members and CRO to build strong professional partnerships, provide credible scientific expertise, and serve as a field-based extension of the clinical trial team to support ongoing studies. The person in this position will be responsible for all aspects of investigator and clinical staff training, as well as surgical device and cell product technical support during surgeries. This individual will also be responsible for exchanging scientific data and other medical and/or scientific information, thus serving as a scientific partner to KOLs, both inside and outside of the operating room.
This role will report to the Lead Surgical Science Liaison, Ophthalmology. This will be a remote (field-based) position. Responsibilities: Support and provide requested guidance to the Investigator, operating room and clinical staff through in-person Operating Room attendance during surgeries.
Work with clinical and technical teams to develop surgical training materials and implement and oversee surgical training program. Work with clinical and technical teams to develop quality resources and knowledge assessment tools for the training of physicians and clinical support staff. Collect and internally communicate technical surgical information and feedback from clinical investigators.
Provide clinical support for all hands-on skills development and procedure training. Arrange surgical training (either individual on-site and/or centralized): wet-labs (agenda, coordination and execution), surgical choreography, surgical manual maintenance and updates, training material development and presentation. Provide on-site support during surgical procedure.
Assist in the development and continued refinement of procedure training materials and manuals in collaboration with internal and external stakeholders to ensure standardized approach in the surgical delivery of cells. Be well-versed in current medical/scientific research, and publications related to diseases of the retina. Establish, foster, cultivate and maintain relationships with KOLs in inherited retinal diseases.
Engage in scientific discussions with HCPs and ensure appropriate dissemination of clinical and scientific information in a timely and compliant manner Present, as needed, at clinical/surgical sites, congresses, symposia, and training events to provide up-to-date, data-based, scientific and clinical information on BlueRock. Create investigator engagement plans to support site-specific recruitment, site identification and/or selection Provide clinical trial liaison support to site investigators involved in sponsored studies including protocol support, screening barriers, and clinical trial recruitment and retention Generate feasible, time-bound, prioritized action plans to address any barriers identified at clinical sites, document the plan and meet with the sites regularly to measure progress Serve as a liaison to internal R&D and Clinical Operations functions to ensure the effective support of PIs Collection of key medical insights from PIs to inform refinement of strategies Conduct effective daily administration and operations of the role Provide clinical/scientific expertise to investigators and other health professionals as requested. The requested activities may include Support and provide requested guidance to the Investigator, operating room and clinical staff through in-person Operating Room attendance during surgeries.
Provide real-time connection to BlueRock Therapeutics medical experts in order to resolve questions or safety concerns arising in the operating room. Maintain a thorough and detailed working knowledge of the cell preparation processes and surgical devices in clinical trials. Minimum Requirements: Advanced Clinical/Science Degree needed (e.g., MD, OD, PharmD, PhD, MSN, RN, NP, PA).
Minimum of 5 years related work experience (surgical and/or clinical setting or industry experience) Previous industry based Surgical/MSL experience is preferred. Ophthalmology therapeutic area experience (either in industry or another related setting) is preferred Demonstrated ophthalmic, preferably retina, surgical procedure experience including utilization and knowledge of instruments and equipment Be proficient in GCP (Good Clinical Practice), Adverse Event reporting and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). Experience in understanding the design and execution of clinical trials Experience in creating and delivering scientific presentations, basic experience in medical writing and a general knowledge of biostatistics.
Maintain all necessary certifications, hospital vendor credentialing, and non-human primate facility access requirements, including, but not limited to: HIPAA Certification Blood Borne pathogen Infection Control and Aseptic Technique Fire Safety Individual Institutional Requirements, including up to date vaccinations Able to interact professionally and effectively with customers, physicians, nurses and other medical staff Able to work independently from a remote environment Excellent attention to detail, possessing good organizational and time management skills Computer skills necessary to generate reports, presentations, spreadsheets, etc. Ability to communicate clearly and concisely in written and verbal communications Outstanding organizational skills; proven ability to manage multiple, often complex and sometimes competing objectives, goals and other priorities to effective and efficient conclusion Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas 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 $ 154,000.00 - $ 163,800.00 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.
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