Senior Medical Director, Oncology
Job Summary
To support ongoing clinical studies, the full-time Senior Medical Director, Oncology will provide medical oversight, develop study protocols, and ensure compliance with regulatory standards while working remotely.
Key responsibilities:
- Design, author, and review clinical study documents and protocols
- Act as a medical monitor for assigned clinical studies and discuss study designs with investigators
- Track emerging efficacy and safety profiles of drugs in ongoing trials and provide clinical input for regulatory documents
Required qualifications:
- Medical Doctor (MD) with experience in solid tumor clinical trials, preferably in breast carcinoma
- 8-10 years of clinical development experience in the pharmaceutical or biotechnology industry
- Experience with Phase I-III clinical trials, with a preference for Phase III experience
- Thorough understanding of clinical trial design, methodology, and statistical concepts
- In-depth knowledge of GCP/ICH guidelines and the IND/NDA process
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