Medical Director (Clinical Development)

About the role

Roche is hiring a Medical Director for its Clinical Development function in Shanghai. The role sits within the Clinical Science Team and covers strategy, planning and execution of clinical studies, with a focus on metabolism, obesity and diabetes. 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
• Contribute to the design, development and execution of clinical studies, including product safety profiles, investigator brochures and study protocols
• 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
• Review medical and safety data, interim and final reports, and help close out studies
• Support regulatory activities such as briefing packages, responses to health authority questions, regulatory filings and label/packaging language
• Represent Roche in the local site community and give 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

Required skills

• Strong written and oral communication, presentation and negotiation skills
• Attention to detail, business acumen and decision-making that balances ethics and efficacy
• Ability to lead disease strategies and work with internal and external partners, including KOLs