Clinical Trial and Surgical Science Liaison

Clinical Trial & Surgical Science Liaison (CTSSL)

Blue Rock Therapeutics 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 Blue Rock Therapeutics supporting Blue Rock's Ophthalmology clinical trial pipeline, and the primary Blue Rock 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 Blue Rock'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 Blue Rock.
• 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 Blue Rock 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…