Lead/Senior Medical Director - Neurodegeneration

About the role

Roche's Clinical Development organization develops and executes late-stage (Phase II–III) clinical strategies and plans for its medicines. The Lead Medical Director leads or makes major contributions to the clinical development (CD) strategy and plan for assigned molecules and indications and is responsible for their effective and efficient execution, with greater independence than a Medical Director. The position is based in Shanghai.

Key responsibilities

• Lead or contribute to the CD plan for assigned molecules/indications, gathering and analysing data and ensuring alignment with the CD strategy and annual lifecycle plans
• Work with cross-functional teams and stakeholders (investigators, clinicians, KOLs, PD, research, commercial, legal) to build the plan and its budget and resource needs
• Lead design, development and execution of clinical studies, including study analytics and data management plans, and review medical and safety data
• Guide selection of external investigators and sites, and brief investigators on medical and scientific matters
• Develop communications strategies for studies, including investigator meetings, KOL interactions, advisory boards, conferences and publications
• Deliver key internal and external presentations and advise on early development, Phase I and II protocols, and transition to Medical Affairs studies
• Provide clinical science input to Lifecycle Plans, the Integrated Development Commercialization Plan and possible M&A or partnership discussions

Required profile

• M.D. degree required
• Relevant clinical, scientific or clinical trial/development experience in the same or similar therapeutic area
• 4+ years of pharma/biotech experience or recognition as a local expert (e.g. Assistant Professor)
• Significant experience designing and running clinical trials, and significant experience with data analysis and interpretation
• Preferred: academic or teaching background, published peer-reviewed study results, and experience authoring a global development plan

Required skills

• Knowledge of medical aspects of GCP, ICH, FDA and EMA guidelines and regulations
• Understanding of Phase II–III drug development; knowledge of Phase I and IV is a plus
• Understanding of product and safety profiles
• Strong written and oral communication, presentation, negotiation and mentoring skills