Sr. Director, Core Capabilities (Clinical Operation)

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 (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 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 community-mindedness with the understanding that we are all part of something bigger than ourselves.

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 cutting-edge cellular therapies to impact patients' lives.

The Sr Director, Core Capabilities is responsible for oversight, strategic planning, and delivery of foundational capabilities necessary to support BlueRock's current and future clinical program and trial execution and oversight. This includes, but may not be limited to, sub-functions Clinical Quality Operations, Patient Recruitment and Retention, Site Performance Optimization and Metrics & Systems.

This individual must have broad and deep Clinical Operations experience, a strategic mindset and demonstrated ability to build fit-for-purpose solutions for a growing company. The ability to lead and grow talent, cultivate productive cross functional partnerships at all levels and navigate with ease from strategic planning to tactical implementation will be instrumental to the success of this role. The ideal candidate would have successfully led and implemented business process re-engineering initiatives.

Responsibilities:

• Clinical Operations Leadership
• Provide strategic and operational leadership ensuring suitable infrastructure to support the successful planning and execution of clinical studies from early-phase through pivotal trials.
• Cultivate broad cross functional organizational relationships in order to advance department initiatives and projects.
• Model a data driven mindset to planning and oversight of clinical programs and studies.
• Drive efforts in support of strategic operational planning and quality execution.
• Actively contribute to the growth and evolution of the Clinical Operations organization and people development.
• 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.
• Process Development & Optimization
• Identify, lead and prioritize critical process and infrastructure initiatives foundational to timely and quality delivery of BlueRock clinical studies and programs.
• Negotiate with process owners, influencers and stakeholders in the development and optimization of new standards.
• Clinical Compliance
• Guide the evolution of process and standards in order to ensure clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines.
• Act as a GCP Subject Matter Expert and partner with team to develop appropriate solutions.
• Establish and oversee methods to monitor risk & compliance in collaboration with key partners (e.g., Quality Assurance).
• Team Leadership & Development
• Plan and grow a Core Capabilities function that to meet
• 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 and clinical operations.
• Ensure the uptake of new process and systems with stakeholders and the user community. Follow through to implementation and optimization.

Minimum Requirements:

• Bachelor's degree in life sciences or related field.
• 15+ years' experience in clinical operations management or leadership within the pharmaceutical or biotech industry, including roles in multiple technical areas.
• Proven track record of direct management of clinical operations personnel.
• Broad clinical development experience across early and late phase including involved in global, multi-site clinical programs; strong preference for cell/gene therapy or biologics experience; therapeutic area experience in neurology and/or ophthalmology a plus.
• Deep knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA).
• Track record driving initiatives related to clinical compliance and inspection readiness and continuous improvement.
• Strong project management, communication, and problem-solving skills.
• Ability to thrive in a fast-paced, matrixed, and innovative environment.
• Broad therapeutic experience including complex indications/rare disease advanced therapy trials and experience in cell or gene therapy is highly desirable.
• Willingness to travel domestically and internationally as needed (up to 20%).
• Full-time position
• Location: Cambridge, MA (Remote or hybrid work arrangements available)