Backed by GV.
About the role
The Medical Director provides medical oversight for assigned clinical trials and serves as the primary medical resource for investigators and study teams. This individual is responsible for ensuring participant safety, supporting protocol execution, reviewing clinical data, and contributing to high-quality study conduct in accordance with GCP, regulatory requirements, and company objectives.
What they're looking for
- 5+ years of clinical experience and/or pharmaceutical or biotechnology industry experience
- Experience serving as a Medical Monitor or Medical Director for interventional clinical trials
- Experience supporting Phase 1 clinical studies in hematology / oncology preferred
- Strong understanding of ICH-GCP, FDA regulations, and clinical trial conduct
- Experience reviewing safety data and making medical decisions during clinical trials
- Ability to interpret clinical data and identify emerging safety signals
More about this role
The Medical Director provides medical oversight for assigned clinical trials and serves as the primary medical resource for investigators and study teams. This individual is responsible for ensuring participant safety, supporting protocol execution, reviewing clinical data, and contributing to high-quality study conduct in accordance with GCP, regulatory requirements, and company objectives.
Working collaboratively across Clinical Development, Clinical Operations, Safety, Biometrics, Regulatory Affairs, and external partners, the Medical Director helps ensure studies are conducted efficiently while maintaining scientific integrity and patient safety.
- Serve as the medical monitor for one or more clinical studies.
- Review safety data and emerging clinical information throughout study conduct.
- Provide timely medical guidance to investigative sites and CRO partners.
- Participate in eligibility reviews, protocol deviation assessments, and subject management discussions.
- Review serious adverse events (SAEs), adverse events of special interest (AESIs), and other safety information in collaboration with Pharmacovigilance.
- Support medical decision-making regarding dose...
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