Principal Medical Director Multiple Sclerosis & Neuroimmunology
The Position
Roche's Clinical Development organization is structured by therapeutic areas and is responsible for developing and executing the clinical development strategies and plans that deliver medically differentiated therapies and provide meaningful improvement to patients.
The Opportunity
We are seeking an experienced and highly specialized individual to join the Neuroimmunology Team within the Neurology Therapeutic Area. The Principal Medical Director will focus on guiding the development of our MS & Neuroimmunology portfolio. The ideal candidate will have extensive experience in Neuroimmunology drug development. Specific experience in multiple sclerosis is required.
* The Principal Medical Director leads Clinical Development strategy, and ensures effective and efficient execution for assigned molecule(s)/indication(s). This role performs responsibilities independently and leads multiple projects. It may be assigned CD strategy development and implementation oversight for an entire brand or franchise.
* This position requires collaboration with cross-functional teams across the drug development value chain, including research and early development, regulatory affairs, data sciences, and biomarkers, to ensure efficient decision-making and successful progression of treatments through the pipeline.
* A strong understanding of Neuroimmunological disease and Multiple Sclerosis, clinical trial protocols, regulatory requirements, and interactions with regulatory agencies is necessary to ensure studies meet the required standards.
Requirements
* MD, MBBS or MD (MBBS)/PhD, board eligible/board certified in Neurology, and fellowship training in MS / Neuroimmunology; recognized MS (+/- Neuroimmunology) expert and thought leader with a minimum of 4 years industry experience.
* Significant clinical trial/development experience in MS and/or Neuroimmunology.
* Experience authoring global clinical development plans and working with various health authorities, including the FDA, EMA, and others; significant regulatory experience, providing clinical science information and input for regulatory submissions and processes.
* Extensive understanding of Phase II – III drug development; knowledge and understanding of Phase I & IV drug development.
* Outstanding interpersonal, verbal communication, and influencing skills; proven abilities to influence internal partners, thought leaders, national advocacy organizations, and other relevant external parties; outstanding business presentation skills and the ability to facilitate effective decision-making.
Preferred Qualifications
* Early clinical development and Phase I experience; clinical trial/development experience in other areas of Neurology.
* Experience collaborating with multidisciplinary internal groups, resulting in demonstrable outcomes; evidence of major contributions to a local site community and the global community, including initiating and organizing special events and discussions.
* A strong orientation to teamwork and skills in conflict resolution.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.