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Director, Endocrine Oncology Clinical Development at Crinetics Pharmaceuticals
San Diego, CA, US

Crinetics is seeking a highly motivated Director, Endocrine Oncology Clinical Development. This role will be accountable for working within a multi-disciplined development team in the development and management of Crinetics’ endocrine oncology portfolio. Initially, this individual will provide clinical expertise and strategic insights to help shape, inform and execute the overall development strategy for the Crinetics clinical development program in neuroendocrine tumors. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Responsibilities:

These may include but are not limited to:

  • Create and lead an efficient clinical development strategy for Crinetics products for neuroendocrine tumors. This will involve focused multidisciplinary internal and external consultation and strategic planning.
  • Lead protocol development and implementation consistent with this strategy
    • Collaboratively assist in drawing up project development timelines in coordination with other functions represented on development team; provide timely updates to development team
    • Author clinical protocols, amendments and related documents
    • Provide medical monitoring for clinical studies in collaboration with CRO medical monitors
    • Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements
    • Support Patient Reported Outcome research for the studies
  • Develop effective working relationships with key investigators in oncology to optimize scientific quality/ innovation of clinical study design, execution, reporting, and publication
  • Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions. Contribute to trial-related advisory boards; lead investigator meetings; lead protocol training meetings
  • Collaborate with Commercial members in interfacing with advocacy groups and holding advisory boards, representing and leading the discussion of clinical activities and plans and gathering and responding to external feedback

Additional Responsibilities:

  • Participate in ongoing and formal (interim and final) data analyses for the study and planned/actual filing activities as required
  • Serve as the external clinical “face” of the program in interactions with development partners, and leading clinical discussions at advisory boards, as needed
  • Support writing of and submit request for Breakthrough Designation or other filing opportunities as appropriate
  • Other duties as assigned

Minimum Qualifications:

  • Minimum of an MD degree with at least 2 years’ clinical research experience in oncology clinical development within a biotechnology, biopharmaceutical, and/or pharmaceutical company (an equivalent combination of experience and education may be considered). Oncology sub specialty board certification preferred
  • Broad understanding of oncology, internal medicine and clinical pharmacology
  • Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development, developed through success in gaining approvals
  • Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives)
  • Strong communication and collaboration skills
  • Prior experience as a medical monitor for a Phase 2-3 oncology study and BLA/NDA filing experience strongly preferred
  • Experience in endocrine oncology or neuroendocrine tumors a strong plus

Travel:

Travel may be required up to 25% of your time