Third Rock Ventures | Director/ Sr. Director, Clinical Operations

6 days ago

cambridge, United States Third Rock Ventures Full time

A well-funded and highly innovative start up from Third Rock Ventures is emerging out of stealth with a syndicate of marquee investors and is seeking an experienced Clinical Operations leader. Reporting to the SVP of Clinical Development and Operations this person will be responsible for leading clinical operations.


Job Responsibilities

  • Responsible for leadership of Clinical Operations, ensuring resourcing and operational execution of all clinical programs within the R&D organization.
  • Be responsible and accountable for planning and execution of clinical projects: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall clinical strategy.
  • Be responsible for Clinical Operations functional and project budget, forecasting, long-range plan, reporting with Finance and Project Management.
  • Set operational performance goals, key performance indicators and targets.
  • Provide input in development of clinical plans, detailed study plans, synopses, and protocols
  • Partner with Strategic Sourcing & Vendor Mgmt on outsourcing strategy and oversight of clinical trial resources, including strategic partnerships/preferred relationships with CROs, vendors, investigators and other external partners.
  • Provide leadership and support to Study Start-up: responsible for overseeing all clinical start-up activities including feasibility, site selection/recommendation, CTAs, study plans and documentation (e.g. ICFs, CRFs, etc.), budget & timeline planning, supply chain, and regulatory preparation.
  • Support clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
  • Partner with Strategic Sourcing & Vendor Mgmt and QA on strategy and oversight of overall quality management systems for Clinical Operations including quality oversight, vendor oversight, SOP systems, training, documentation, and GCP compliance.


Job Requirements:

  • Bachelors science
  • 10+ years of clinical operations experience in a pharmaceutical or biotech or CRO setting
  • You have strong clinical trial feasibility, planning, and execution experience across both Phase1/early-stage and registrational/late-stage development programs, including managing and overseeing operational teams and clinical trial sites and external vendors/CROs
  • You have IND submission experience
  • You may also have NDA submission experience
  • You have excellent leadership skills and ability to direct and support cross-functional teams
  • You have strong interpersonal, organizational, budgeting/forecasting, and multi-tasking skills
  • You have excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, and have inspection experience

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