Associate Director, Clinical Operations Study Lead (COSL)

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy 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, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 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. 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.

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.

Key Responsibilities:

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).

• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.


• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.


• Actively contributes to the advancement of department and organizational initiatives and processes.

• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.


• Participate in the mentorship of clinical operations staff.

• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.

• Bachelor’s degree in life sciences or related field


• 7+ years’ experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 2 years in a study or team leadership role in a pharma or biotech company.


• Experience supporting both early and late-stage clinical studies. Preference for experience with BLA-enabling trials.


• Demonstrated success managing complex clinical studies in global settings; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology preferred.


• Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).


• Strong vendor management skills and experience with complex outsourcing and partnership models


• Proven financial acumen. Experience managing within a study budget, managing and reporting on change order status


• Exceptional verbal and written communication and stakeholder management skills . Track record of developing and delivering high quality materials and updates for leadership forums.


• Demonstrated ability to effectively collaborate with internal and external stakeholders in a highly matrixed setting


• Ability to thrive in a fast-paced, matrixed, and innovative environment.

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