Executive Medical Director, Clinical Development

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

Responsibilities

• Provide clinical scientific and medical leadership for the clinical study team and cross-functional workstreams
• Provide medical safety oversight of CRO medical monitors
• Lead the design and writing of clinical protocols and associated clinical documents
• Lead the writing of clinical and safety sections of key Program documents including IND, Investigator Brochures, CSR, DSUR, and BLA
• Prepare, analyze, and present safety data to internal and external safety monitoring boards
• Represent Immunovant externally to build relationships with trial site Investigators, KOLs, and other stakeholders
• Comply with SOPs and adhere to ICH, GCP, and relevant regulatory guidelines

Requirements

• MD, DO, or non-US equivalent of MD degree
• Minimum of 8 years of experience in early to late-stage development in a CRO or Pharma setting
• Proven ability to plan and conduct clinical trials
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines
• Strong analytical, problem-solving, and strategic planning skills
• Exceptional written and oral communication skills

Preferred Qualifications

• Board certification in Neurology
• Prior late-phase clinical trial experience in neurology
• Prior interactions with FDA and EMA regulatory agencies