Medical Director - CVM

About the role

Roche is hiring a Medical Director for its CVM function in Shanghai. The role sits within the Clinical Science Team (CST) and covers strategy, planning and execution of clinical studies, medical monitoring, regulatory support and stakeholder engagement. Up to 30% global travel is required.

Key responsibilities

• Take part in developing the clinical development (CD) plan for assigned molecules and indications, including analytics/data strategy, KOL development and publications strategy, and help define budget and resource needs
• Contribute to the design, development and execution of clinical studies, including product safety profiles, investigator brochures and study analytics and data management plans
• Guide the selection of external investigators and sites, and act as a medical monitor for assigned studies
• Support communications around studies, including investigator meetings, advisory boards, congresses and publications, and give input to Phase I and II protocols and MA study protocols
• Review medical and safety data, track study progress and ensure timely interim and final reporting
• Help prepare briefing packages, answers to health authority questions and regulatory filings, including label and packaging language, under the supervision of more experienced Medical Directors
• Represent Roche in the local site community and share study and program updates

Required profile

• M.D. degree required
• 2 or more years of post-graduate academic or clinical experience
• Knowledge of metabolism, obesity and diabetes, with clinical, scientific and clinical trial/development experience
• Experience with data analysis, interpretation and clinical relevance; publication in a peer-reviewed journal preferred
• Preferred: knowledge of GCP, ICH, FDA and EMA guidelines
• Impeccable ethics, strong attention to detail, good negotiation and decision-making skills, and willingness to travel globally