Senior Medical Director
Sagimet Biosciences · Foster City, CA · 2 mo ago
HybridOTHRFull-time
About the role
As a Senior Medical Director, you will play a critical role in planning and executing Sagimet’s clinical trial programs. You will collaborate closely with cross-functional team members, including representatives from Clinical Operations, Regulatory Affairs, Safety Pharmacovigilance, Translational Sciences and Biomarkers, Biometrics, Medical Writing, Research & Development, and Program Management. Your expertise will drive successful planning, execution, analysis, and reporting of clinical trials and contribute to the advancement of novel therapies.
Responsibilities
- Design, analysis, interpretation, and reporting of clinical trials.
- Provide medical leadership for the development of clinical study protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other study-related documents.
- Monitor ongoing clinical trials, ensuring adherence to protocols, safety guidelines, and regulatory requirements.
- Review safety events, adverse reactions, and serious adverse events (SAEs).
- Work closely with the Clinical Operations team to support trial execution.
- Serve as the key medical contact for study investigators, DSMBs, and IRBs.
- Provide scientific and strategic leadership, contributing to trial design, endpoints, and patient selection.
- Collaborate with cross-functional team members to develop scientifically sound clinical trial protocols, statistical analysis plans, and other study documents that are feasible to execute.
- Contribute to interactions with regulatory authorities and regulatory submissions.
- Collaborate with study investigators in the preparation, submission, and presentation of scientific data at scientific meetings and congresses.
- Maintain current knowledge of therapeutic areas and industry advancements through conferences, literature, and training.
- Represent the company at scientific conferences and engage with key opinion leaders.
Requirements
- Medical degree (MD) with board certification; dermatology experience would be a plus.
- 5+ years of experience in clinical development within the biotechnology or pharmaceutical industry with expertise in clinical trial design, execution, and data analysis.
- Expertise in dermatology studies would be a plus.
- Experience in regulatory interactions, submissions, and/or NDA/BLA filings.
- Experience in scientific communication of clinical results through presentations to internal and external audiences, abstracts, and publications.
- Excellent verbal and written communication skills, with the ability to collaborate effectively with thought leaders and investigators.
- Strong decision-making skills and ability to provide scientific and strategic leadership.
- Ability to work in a fast-paced, small company environment with multiple competing responsibilities.
Schedule
Position involves 10-20% travel.