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- Design, oversee, and execute clinical deliverables to support defined program objectives, including document development, contribution to key documents, and providing medical and scientific input throughout study lifecycle.
- Review, analyze, interpret, and present clinical data internally and externally, representing clinical studies or programs on relevant teams or subteams.
- Develop and optimize KOL and investigator communication strategies, organizing advisory board and investigator meetings as needed.
- MD or non-US equivalent.
- 10+ years of clinical trial experience encompassing early and late-phase development, with at least 4 years in the industry. Consideration may be given to candidates with exceptional experience in other therapeutic areas, particularly if they demonstrate potential for application in oncology.
- Expertise in radiopharmaceuticals is a plus.
- Profound understanding of clinical development phases, including familiarity with drug approval processes in the US and internationally.
- Experience in all aspects of protocol conduct, from writing to execution, analysis, and reporting.
- Strong knowledge of FDA regulations, Good Clinical Practices, and clinical trials guidelines.
Medical Director/Senior Medical Director - San Francisco, United States - GQR
Description
The Director/Senior Medical Director, reporting to the Chief Medical Officer, plays a pivotal role in steering clinical development initiatives. With a focus on ensuring adherence to GCP, SOPs, and regulatory standards, this role orchestrates the planning and execution of clinical studies, driving programs through the research process efficiently.
Key Responsibilities:
Qualifications, Education & Experience:
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