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.
Clinical Development
- Design, analysis, interpretation, and reporting of clinical trials.
- 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).
Collaboration and Leadership
- Work closely with the Clinical Operations team to support trial execution.
- Key medical contact for study investigators, DSMBs, 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 meets 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.
Education and Experience
- 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, ability to collaborate effectively with thought leaders and investigators.
- Ability to provide scientific and strategic leadership.
- Ability to work in a fast‑paced, small company environment with multiple competing responsibilities.