Job Description
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 of clinical trials. This role is essential to advancing the companys innovative pipeline and involves working closely with crossfunctional 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 sciencedriven environment where medical leadership directly impacts the development of lifechanging therapies.
Key Responsibilities
Medical Monitoring & Clinical Oversight:
- Act as the Medical Monitor for clinical trials ensuring protocol adherence patient safety and data integrity.
- Provide realtime 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 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 & CrossFunctional Leadership:
- Partner with clinical operations regulatory and commercial teams to drive development strategy.
- Engage with key opinion leaders (KOLs) and investigators to enhance trial 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 IIIII 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 biomarkerdriven clinical trials and translational medicine.
- Understanding of realworld data (RWD) and AIdriven clinical development approaches.
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Required Experience:
Director