Clinical Development Medical Director

3 weeks ago

Menlo Park, California, United States GRAIL, Inc. Full time

Clinical Development Medical Director

The Medical Director in Clinical Development at GRAIL, Inc. plays a pivotal role in providing clinical expertise to support the design, conduct, and analysis of clinical and real-world evidence studies. This position is responsible for collaborating with cross-functional teams to ensure the success of GRAIL's product pipeline and commercial launch.

Key Responsibilities:

  • Act as a medical monitor for designated clinical and/or real-world evidence studies, serving as a member of the cross-functional clinical study management team.
  • Issue queries and communicate with clinical study site staff to ensure completeness and accuracy of clinical data.
  • Prepare and review answers to safety queries from regulatory authorities and IRBs as needed.
  • Collaborate with other medical directors, clinical scientists, clinical data managers, biostatisticians, data scientists, and other functional stakeholders on the design, conduct, and analysis of clinical studies.
  • Contribute to the development and preparation of regulatory documents.
  • Provide scientific and medical support for publications and presentations to ensure scientific and medical accuracy and cross-functional alignment.
  • Support efforts to advance clinical development and scientific research plans.
  • Develop formal networks with external investigators and thought leaders to support clinical study programs.
  • Ensure compliance with industry regulations, policies, guidelines, and standards.

Requirements:

  • MD required, board certified/board eligible in oncology strongly preferred.
  • 3+ years of experience in a diagnostics or pharmaceutical Clinical Development setting.
  • Experience in designing and conducting clinical studies, particularly registrational and/or clinical utility studies for reimbursement.
  • Prior experience in a medical monitoring role strongly preferred, including medical case review and assessment of adverse event reports to determine seriousness and reportability.
  • Experience in oncology, genomics, diagnostics, cell-free DNA-based applications, or similar applied medical fields is strongly preferred.
  • Familiarity with the development of real-world evidence from real-world data (e.g., healthcare claims or electronic health records).
  • Knowledge of regulatory requirements (e.g., experience authoring Standard Operating Procedures (SOPs) and similar documents in support of the role and responsibilities of a Medical Director).

GRAIL, Inc. is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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