Head of Clinical Operations
C4 Therapeutics Inc Watertown, MA
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C4 Therapeutics is seeking an experienced and motivated Head of Clinical Operations to enable the clinical development of our pipeline. The ideal candidate will have the scientific background and 10+ years of industry experience, including both biotech and larger company experience in Clinical Operations as well as experience and interest in oncology. You will help build the clinical team, lead clinical operations and contribute as a clinical scientist. This person will be comfortable communicating timelines, strategies, and results to company leadership. Candidates must be nimble and able to communicate efficiently in a fast-paced, team-based setting.

Responsibilities:

  • Provide key input to building the clinical group
  • Contribute as both leader of clinical operations and as a clinical scientist
  • Development and maintenance of standards across clinical studies
  • Hiring, oversight, training, and management of the clinical operations team
  • Management of the performance of CROs through frequent and meaningful contact
  • Oversight of integrated development strategy (clinical development plan, drug supply strategy, regulatory compliance, document authorship, budgeting, vendor management, etc)
  • Assist in medical issue management
  • Lead data review ensuring GCP
  • Manage program resource allocation and budget as well as project timelines
  • Communication of timelines, strategies, and results in company leadership
  • Contribute to writing and preparation of key documents including study protocols, case study reports and investigator brochures
  • Oversight of site selection, enrollment strategy, timeline management

Requirements/Qualifications:

  • Advanced degree in the biomedical field
  • 10+ years of relevant biopharma/pharma experience
    • both biotech and pharma experience preferred
    • early phase oncology experience preferred
    • Expertise in clinical operations and clinical development
    • Experience with vendor and site contract negotiation and management
    • Knowledge of ICH, GCP and FDA guidelines
    • Nimble thinker
    • Concise communicator
    • Ability to lead the multi-disciplinary clinical team
    • Strong motivation, independence, and ability to work in a high-pace multidisciplinary, matrix environment with minimal supervision.
    • Ability to work independently and apply experience and knowledge to solve difficult challenges and provide useful guidance to other team members
    • Demonstrated ability to effectively manage and mentor research staff
    • Willingness to travel (site visits, conferences, etc.)
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