Medical Director – Medical Monitor, Obesity

Location: San Francisco| Hybrid/Remote Option Available

About the Role

A growing biotech company is seeking a Medical Director – Medical Monitor to provide strategic medical oversight and ensure the successful execution of clinical trials. This role is essential to advancing the company’s innovative pipeline and involves working closely with cross-functional teams to drive clinical development forward.

The ideal candidate will have deep experience in clinical trial oversight, safety monitoring, and regulatory interactions, with the ability to interpret complex clinical data and ensure patient safety. This is an opportunity to be part of a dynamic, science-driven environment where medical leadership directly impacts the development of life-changing therapies.

Key Responsibilities

Medical Monitoring & Clinical Oversight:

• Act as the Medical Monitor for clinical trials, ensuring protocol adherence, patient safety, and data integrity.
• Provide real-time medical oversight, including reviewing adverse events (AEs/SAEs), dose modifications, and protocol deviations.
• Collaborate with investigators and clinical teams to address medical inquiries and safety concerns.
• Contribute to the design and execution of clinical trial protocols, investigator brochures, and informed consent forms.
• Lead data reviews and safety monitoring efforts, ensuring trial integrity and compliance.

Regulatory & Safety Compliance:

• Work with safety and pharmacovigilance teams to assess, report, and mitigate patient risks.
• Provide medical expertise for regulatory submissions (IND, CTA, NDA, BLA) and interactions with health authorities.
• Support Data Safety Monitoring Boards (DSMBs) and Clinical Trial Steering Committees as needed.

Strategic & Cross-Functional Leadership:

• Partner with clinical operations, regulatory, and commercial teams to drive development strategy.
• Engage with key opinion leaders (KOLs) and investigators to enhance trial execution and scientific credibility.
• Represent the company at scientific meetings, conferences, and regulatory discussions.
• Contribute to medical and scientific communications, including publications and congress presentations.

Qualifications & Experience

Required:

• M.D. 
• 2+ years of experience in clinical development within a biotech/pharma setting.
• Experience as a Medical Monitor in Phase II-III clinical trials in Obesity.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.).
• Ability to analyze and interpret clinical trial data, ensuring scientific rigor and integrity.
• Excellent communication skills, with the ability to collaborate with KOLs, regulatory bodies, and internal teams.

Preferred:

•  Expertise in Metabolic Disorders / Endocrinology
•  Experience in regulatory interactions (FDA/EMA meetings, IND/NDA/BLA submissions).
•  Background in biomarker-driven clinical trials and translational medicine.
•  Understanding of real-world data (RWD) and AI-driven clinical development approaches.

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