Sr. Director - Clinical Operations Program Leader (COPL) - Ophthalmology

BlueRock Therapeutics•Cambridge, MA

6d•$240,000 - $280,000•Hybrid

About The Position

The Clinical Operations Program Leader (COPL) is responsible for the strategic planning, execution, and oversight of BlueRock’s clinical development programs across multiple studies and geographies specifically for our Ophthalmology programs. This leadership role ensures alignment with corporate goals, regulatory requirements, and timelines, while fostering cross-functional collaboration and operational excellence in the advancement of next-generation cell therapies.

Requirements

Bachelor’s degree in life sciences or related field (advanced degree preferred: MS, PhD, PharmD, MD, NP, PA, or equivalent).
12+ years’ experience in clinical operations within the pharmaceutical or biotech industry, including at least 5 years in a program or team leadership role.
Proven experience with the direct management of clinical operations personnel.
Demonstrated success managing global, multi-site clinical programs; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in ophthalmology a plus.
Deep knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
Proven experience with CRO/vendor selection and management.
Strong project management, communication, and problem-solving skills.
Ability to thrive in a fast-paced, matrixed, and innovative environment.
Experience in early-phase (FIH, IND/CTA) clinical trials
Willingness to travel domestically and internationally as needed (up to 20%).

Nice To Haves

Experience neurology, ophthalmology or rare disease/advanced therapy trials is highly desirable.

Responsibilities

Clinical Program Leadership: Provide strategic and operational leadership for one or more complex clinical programs, ensuring successful execution from early-phase through pivotal trials.
Develop and maintain clinical program planning and execution timelines.
Model a data driven mindset to planning and oversight of studies.
Maintain a comprehensive overview of program status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
Drive operational planning, including feasibility assessments, country/site selection, and resource allocation.
Clinical Trial Operations: Oversee all aspects of clinical trial management, including protocol development, study start-up, enrollment, monitoring, data collection, and close-out.
Ensure adherence to timelines, budgets, and quality standards across all studies within the program.
Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators) to ensure seamless trial execution.
Implement and track key performance indicators (KPIs) and operational dashboards to monitor program health.
Vendor & Site Management: Lead the selection, qualification, and management of CROs and vendors, ensuring high-quality deliverables and contract compliance.
Serve as the primary point of escalation for operational issues at the program level.
Build and maintain strong relationships with clinical trial sites, investigators, and key opinion leaders.
Compliance & Process Improvement: Ensure all clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines.
Support audit readiness and lead risk mitigation initiatives.
Contribute to the advancement of department and organizational initiatives.
Team Leadership & Development: Provide line management, coaching, and mentorship to clinical operations staff.
Foster a culture of accountability, innovation, and professional growth.
Innovation: Champion the development and implementation of novel clinical operations activities and methods in cell therapy.