Director, Clinical Operations Study Lead

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.

The Director of Clinical Operations Study Lead (COSL) oversees the management and operations of one or more BlueRock clinical trials. The individual in this role is the accountable BlueRock 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.

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.
• Translates program strategy into executable study plans and milestones. Develops 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).
• May represent Clinical Operations on Development and/or Program Team (under supervision of Clinical Operations Sr Management).
• Supports the Clin Ops Sr. Management in the development of timelines and aspects of strategic operational planning at the program level (eg scenario development).
  
  

Compliance & Process Improvement

• 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.
• Team Leadership & Development
• 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.
• May provide line management, coaching, and mentorship to clinical operations staff.
  
  

Innovation

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

Minimum Requirements

• Bachelor’s degree in life sciences or related field
• 10 years’ experience in clinical operations within the pharmaceutical, biotech and or CRO setting including at least 4 years in a study or team leadership role in a pharma or biotech company.
• Experience supporting 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. Experience in conducting pediatric studies a plus.
• 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 building and maintaining study budgets.
• 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.
  
  

The estimated compensation range for this position is $ 202,000.00 - $ 214,020.00 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. If you would like more information about how your data is processed, please contact us.