- 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
- 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
- Prior experience in a medial monitoring role, including medical case review and assessment of adverse event reports to determine seriousness and report-ability
- Experience in designing and conducting clinical studies, particularly registrational and/or clinical utility studies for reimbursement
- 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
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Medical Director, Clinical Development # - Raleigh, United States - GRAIL, Inc.
Description
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. This position is based in Menlo Park, CA. with requirement of being 2 days onsite every week.
Responsibilities:
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