Medical Director, Clinical Development #4003
- Employer
- GRAIL Inc
- Location
- Menlo Park, CA
- Start date
- Nov 22, 2024
View more categoriesView less categories
- Discipline
- Clinical, Clinical Development, Clinical Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Bio NC, Best Places to Work
Job Details
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
Preferred Qualifications:
- 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
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.
Company
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
LEADERSHIP:
CEO: Bob Ragusa
Stock Exchange: NASDAQ
Stock Symbol: GRAL
- Website
- https://grail.com/
- Phone
- 833-694-2553
- Location
-
1525 O'Brien Drive
Menlo Park
California
94025
United States
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