Associate Director, Clinical Operations Study Lead

BlueRock Therapeutics; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

BlueRock Therapeutics in Cambridge, MA is seeking an Associate Director, Clinical Operations Study Lead to oversee clinical trial management. This role is crucial for ensuring successful execution and regulatory compliance in innovative cell therapies.

The ideal candidate will lead cross-functional teams and require 7+ years experience in clinical operations, with a strong focus on cell and gene therapy. The position fosters a collaborative environment and aims to transform treatment options for patients.

Qualifications

• 7+ years' experience in clinical operations within pharmaceutical or biotech.
• Experience in study or team leadership role.
• Strong preference for cell/gene therapy or biologics experience.

Responsibilities

• Oversee management and operations of BlueRock clinical trials.
• Ensure studies are conducted in alignment with regulatory requirements.
• Drive operational initiatives key to successful study execution.

Skills

Clinical Operations

Project Management

Stakeholder Management

Regulatory Compliance

Vendor Management

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS

eTMF

EDC

Job description

## Associate Director, Clinical Operations Study LeadApplyremote type: OnSitelocations: MA-Cambridgetime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR2BlueRock 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+GENETM 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 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+GENETM 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.**Our Pipeline Vision:****Neurology**BlueRock 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**BlueRock is expanding its innovative cell therapy portfolio into ophthalmology, with a focus on addressing unmet medical needs in retinal diseases. Our lead ophthalmology program, **OpCT001**, 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). OpCT001 leverages our CELL+GENETM platform to generate authentic, functional RPE cells from pluripotent stem cells, with the goal of restoring vision and halting disease progression.BlueRock 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.**About the Role**The **Associate Director, 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.-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 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. Participate in the mentorship of 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-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.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.