Sr. Director Clinical Operations Program Leader (COPL)

Work set-up: 
Full Remote
Contract: 
Full time
Experience: 
Senior (5-10 years)
Work from: 
Massachusetts (USA)

Offer summary

Qualifications:

Bachelor's degree in life sciences or related field; advanced degrees preferred., At least 12 years of experience in clinical operations within biotech or pharmaceutical industries., Proven leadership experience managing clinical programs and teams., Strong knowledge of regulatory requirements and clinical trial systems..

Key responsibilities:

  • Lead and oversee multiple clinical development programs from early to pivotal trials.
  • Manage all aspects of clinical trial operations, including protocol development and site management.
  • Coordinate with internal teams and external vendors to ensure seamless trial execution.
  • Ensure compliance with regulatory standards and lead process improvements.

BlueRock Therapeutics logo
BlueRock Therapeutics Biotech: Biology + Technology Scaleup https://www.bluerocktx.com/
201 - 500 Employees
See all jobs

Job description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRTDA01) for the treatment of Parkinson’s disease and OpCT001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and communitymindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cuttingedge cellular therapies to impact patients’ lives.

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 firstinclass, 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 exPDite2 clinical trial ongoing in the US, Canada, and Australia. Additional neurology pipeline assets, including DA02 and MG0X, are in research phase targeting other highimpact 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 firstinclass, 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 agerelated macular degeneration (AMD). OpCT001 leverages our CELL+GENE™ 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 patientcentricity drive every decision.

About the Role:
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. This leadership role ensures alignment with corporate goals, regulatory requirements, and timelines, while fostering crossfunctional collaboration and operational excellence in the advancement of nextgeneration cell therapies.

Responsibilities:
  • Clinical Program Leadership:
  • Provide strategic and operational leadership for one or more complex clinical programs, ensuring successful execution from earlyphase 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, countrysite selection, and resource allocation.

  • Clinical Trial Operations:
  • Oversee all aspects of clinical trial management, including protocol development, study startup, enrollment, monitoring, data collection, and closeout.
  • 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 highquality 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 ICHGCP, 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.

  • Minimum 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, multisite clinical programs; strong preference for cellgene therapy or biologics experience; therapeutic area experience in neurology andorophthalmology a plus.
  • Deep knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICHGCP, FDA, EMA).
  • Proven experience with CROvendor selection and management.
  • Strong project management, communication, and problemsolving skills.
  • Ability to thrive in a fastpaced, matrixed, and innovative environment.
  • Experience in earlyphase (FIH, INDCTA) clinical trials
  • Experience neurology, ophthalmology orrare diseaseadvanced therapy trials is highly desirable.
  • Willingness to travel domestically and internationally as needed (up to 20%).

  • Working Environment:
  • Fulltime position
  • Location: Cambridge, MA (Remote or hybrid work arrangements available)
  • #LIAL1

    BlueRock Therapeutics Company Culture Highlights
    Winner of Boston Business Journals Best Places to Work (Midsize Company) 2023
    Winner of Comparablys Award for Best Company for Diversity 2022
    Winner of Comparablys Award for Best Company for Women 2022
    •

    Required profile

    Experience

    Level of experience: Senior (5-10 years)
    Industry :
    Biotech: Biology + Technology
    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Clinical GovernanceClinical Trial Management SystemsProject ManagementRegulatory ComplianceData ManagementOperations Support SystemsGeneral SurgeryClinical Study DesignGene TherapyBiopharmaceuticalsOphthalmologyCell TherapyNeurology

    Other Skills

    • Team Leadership
    • Mentorship
    • Collaboration
    • Communication
    • Problem Solving
    Are you interested?

    Operations Coordinator Related jobs

    See more Operations Coordinator jobs