Job Description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical-stage cell therapy company focused on developing 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?

We leverage foundational science to create and direct the differentiation of pluripotent stem cells into functional cells for allogeneic cellular therapies. Our goal is to deliver transformative treatments to patients worldwide.

Our Pipeline Vision:

Neurology: We are advancing cell therapies for neurodegenerative and neurological disorders, with our lead program, bemdaneprocel (DA01) , in phase 3 trials for Parkinson's disease. Other assets like DA02 and MG0X are in research stages.

Ophthalmology: Our portfolio includes OpCT001 , targeting retinal diseases such as AMD, aiming to restore vision and halt disease progression.

About the Role:

The Director of Clinical Operations Quality will lead the development of SOPs, processes, and templates to support clinical studies, ensuring compliance with GCP, EU, FDA, and ICH guidelines. This individual will serve as a Subject Matter Expert (SME) and guide clinical operations teams.

Responsibilities:

• Operational Quality Documentation: Develop and manage SOPs, Work Instructions, and templates; implement training curriculums.
• Trial Master File (TMF): Establish TMF standards, oversee inspection readiness, and collaborate with CROs.
• Compliance & Process Improvement: Provide guidance on regulations, support audit readiness, and lead process improvements.
• Leadership: Foster a culture of collaboration, compliance, and operational excellence.

Minimum Requirements:

• Bachelor's in life sciences or related field.
• 10+ years in Clinical Operations within pharma/biotech or CRO, with experience in trial documentation or clinical quality.
• Strong knowledge of GCP, FDA, ICH, and 21 CFR Part 11 regulations.
• Experience in clinical compliance, inspection readiness, and process improvement.
• Excellent collaboration, organization, and communication skills.
• Experience in cell/gene therapy and familiarity with Veeva systems is a plus.

Working Environment:

• Full-time position based in Cambridge, MA, with remote or hybrid options.

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BlueRock is recognized as a top employer with awards for diversity, culture, and leadership. We are an equal opportunity workplace and support diversity and inclusion. Accommodations are available upon request.

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