Description

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.

Essential Responsibilities:

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

Requirements

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
Strong decision-making skills
Ability to work in a fast-paced, small company environment with multiple competing responsibilities
Position involves 10-20% travel

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