Medical Director, Clinical Development #4003

$245,000 - $327,000/Yr

Grail - Menlo Park, CA

Full-time - Senior

Menlo Park, CA

Ambulatory Health Care Services

About the position

The Medical Director in Clinical Development is responsible for providing clinical expertise to support the design, conduct, and analysis of clinical and real-world evidence studies in support of GRAIL's product pipeline as well as commercial launch and post-marketing commitments. This role will interact with cross-functional teams, including colleagues from Clinical Operations, Biostatistics, Clinical Data Management, Medical Affairs, Regulatory Affairs, Research and others.

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
• Collaborate with colleagues from biostatistics to develop statistical analysis plans and serve as a co-author on clinical study reports and other study deliverables
• 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 (review and interpretation of study data; engagement of key opinion leaders; providing strategic and scientific input to study-level and program-level teams)
• 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
• 2 + years of clinical practice experience
• 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. ICH, GCP, HIPAA, ISO) and a commitment to compliance
• Experience authoring Standard Operating Procedures (SOPs) and similar documents in support of the role and responsibilities of a Medical Director
• Excellent verbal and written communication skills, including clear and confident presentation skills
• Ability to network and partner within external investigator and national organizations
• Results oriented and strong attention to detail
• Strong leadership and collaboration skills

Benefits

• The expected, full-time, annual base pay scale for this position is $245,000 - 327,000
• Actual base pay will consider skills, experience, and location.