- 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 # 3729 - Raleigh, United States - BioSpace
Description
Job DetailsGRAIL 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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit .
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:
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL 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. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Medical Director, Clinical Development # 3729 professionals in Raleigh
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Stephanie Ladd
Senior Clinical Research Professional