State Licensed Senior Medical Director

Job Summary

To support ongoing clinical studies, the full-time State Licensed Senior Medical Director will provide medical oversight, drive study design protocol development, and ensure compliance with regulatory standards in a remote setting.

Key responsibilities:

• Design, author, and review clinical study documents including protocols and reports
• Act as a medical monitor for assigned studies and engage with investigators and key opinion leaders
• Oversee clinical database design, data collection, and analysis while tracking drug efficacy and safety profiles

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, particularly Phase III
• Thorough knowledge of clinical trial design, methodology, and statistical concepts
• In-depth understanding of GCP/ICH guidelines and the IND/NDA process