Sr. Director – Clinical Operations Program Leader (COPL)
Job Description
Description
BlueRock Therapeutics LP is a clinical-stage cell therapy company focused on creating new medicines for neurological and ophthalmic diseases. Our investigational therapies include bemdaneprocel (BRT-DA01) for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases. Founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, we foster a culture of persistence, innovation, integrity, and community.
What Are We Doing?
Our science involves creating and directing the differentiation of pluripotent stem cells into functional cells for allogeneic cellular therapies. We also engineer these cells to produce therapeutic proteins, aiming to deliver transformative treatments for patients.
We seek collaborative individuals who thrive in a dynamic environment and are committed to advancing cellular therapies. Our pipeline includes neurology programs like bemdaneprocel (DA01) , currently in phase 3, and other assets in research phases. In ophthalmology, our lead program OpCT-001 aims to restore vision in retinal diseases.
We are committed to scientific excellence, operational rigor, ethics, diversity, and patient-centricity.
About the Role:
The Clinical Operations Program Leader (COPL) will oversee the strategic planning, execution, and management of multiple clinical development programs across geographies, ensuring alignment with regulatory standards and organizational goals.
Responsibilities:
- Clinical Program Leadership:
- Lead complex clinical programs from early to pivotal trials, developing and maintaining timelines and risk mitigation strategies.
- Monitor program status and communicate progress to stakeholders.
- Plan operational aspects including site selection and resource allocation.
- Clinical Trial Operations:
- Manage all trial activities from protocol development to close-out, ensuring quality and compliance.
- Collaborate across departments and with external partners to ensure seamless trial execution.
- Implement KPIs and dashboards for program monitoring.
- Manage CROs and vendors, ensuring contractual and quality standards.
- Build relationships with trial sites and investigators.
- Compliance & Process Improvement:
- Ensure adherence to GCP, FDA, EMA guidelines and support audit readiness.
- Lead risk mitigation and contribute to departmental initiatives.
- Provide mentorship to clinical operations staff and foster a culture of accountability and innovation.
Qualifications include a bachelor’s degree in life sciences, 12+ years in clinical operations with leadership experience, knowledge of clinical trial systems, and willingness to travel up to 20%. Location is Cambridge, MA, with flexible work arrangements.
BlueRock offers a vibrant company culture recognized with multiple awards, and is committed to diversity and inclusion. For more information, visit our LinkedIn page: .
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Company
BlueRock Therapeutics
Location
Cambridge
Country
Canada
Salary
100.000
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