Associate Director, Clinical Operations Study Lead

Associate Director, Clinical Operations Study Lead

Blue Rock Therapeutics, a leading engineered cell therapy company, is 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.

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.

Our Pipeline Vision:

Neurology

Blue Rock is advancing an innovative pipeline of cell therapies in neurology, focused on addressing the urgent needs of patients with neurodegenerative and neurological disorders. Our lead neurology program, bemdaneprocel (DA01), is a first-in-class, allogeneic cell therapy designed to replace lost dopaminergic neurons in patients with Parkinson's disease. This program is currently in phase 3 development with the exPDite-2 clinical trial ongoing in the US, Canada, and Australia.

Additional neurology pipeline assets, including DA02 and MG0X, are in research phase targeting other high-impact neurological conditions. Our goal is to restore function, slow or halt disease progression, and transform the standard of care for patients with debilitating neurological diseases.

Ophthalmology

Blue Rock is expanding its innovative cell therapy portfolio into ophthalmology, with a focus on addressing unmet medical needs in retinal diseases. Our lead ophthalmology program, OpCT
001, is a first-in-class, allogeneic cell therapy candidate designed to replace lost or damaged retinal pigment epithelial (RPE) cells in patients with advanced retinal disorders, such as geographic atrophy secondary to age-related macular degeneration (AMD). OpCT
001 leverages our CELL+GENE™ platform to generate authentic, functional RPE cells from pluripotent stem cells, with the goal of restoring vision and halting disease progression.

Blue Rock is committed to scientific excellence, operational rigor, and the highest standards of ethics and compliance. The company fosters an inclusive, collaborative environment where innovation, diversity, and patient-centricity drive every decision.

The Associate Director, Clinical Operations Study Lead (COSL) oversees the management and operations of one or more Blue Rock clinical trials. The individual in this role is the accountable Blue Rock leader for the operational planning, execution, and oversight of clinical studies. In this role, the COSL ensures that studies are conducted in alignment with regulatory requirements, and timelines, while fostering a culture of cross-functional collaboration and operational excellence.

Clinical Operations & Study Leadership

-Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.

-Develops executable study plans and milestones. Establishes and maintains clinical study timelines.

-Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.

-Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.

-Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)

-Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).

Compliance & Process Improvement

Ensures clinical activities are conducted in…