Roche’s Clinical Development organization, which is part of the Pharma Development organisation, is structured by therapeutic area and is responsible for developing strategies and executing late stage development clinical plans that lead to approval of transformational medicines that provide meaningful improvement to patients. Our group is currently working to discover innovative therapies for patients with major diseases of the nervous system.
One of the major focuses for research and development are neuromuscular disorders such as Spinal Muscular Atrophy (SMA), Duchenne Muscular Dystrophy (DMD) and Amyotrophic Lateral Sclerosis (ALS). The Senior Group Medical Director of Neuromuscular reports to the Global Head of Neuroscience Product Development and leads a global team of Group Medical Directors and Clinical Science Teams who are responsible for creating clinical development strategies and plans and ensuring their effective and efficient execution.
• Direct management of a team of c. 10 FTEs. Coach, manage and support employees to achieve business goals. Actively manage and provide career development for global cross-functional team.
• Recruit and attract top tier talent into the organization to further build capabilities in the neurodegenerative space
• Broadly represent the interests of Product Development Neuroscience (PDN) within Roche and Genentech, as a member of the Product Development Neuroscience (PDN) Leadership Team, as well as through interactions with Research, Biomarkers, Early Development, Medical Affairs, Commercial, Regulatory and Business Development senior leaders.
• Represent the interests and views of Product Development Neuroscience (PDN) and Roche and Genentech in key external collaborations and consortia in the AD space
• Development Review Committee responsibility for assigned molecules in the portfolio
• Accountable for the strategic clinical development of all late stage programs in SMA, DMD and ALS – including the clinical development plan, design, implementation of studies and leadership of all health authority interactions.
• Closely interface with early development groups to define opportunities to explore new areas of scientific discovery
• Evaluate approved and late stage PDN molecules for new indication opportunities
Candidates should have an M.D. or M.D./Ph.D. with board certification or eligibility in Neurology ideally with a focus on pediatric Neuromuscular Disorders (SMA, DMD)
• Expertise in clinical drug development is strongly desired, e.g. 10+ years pharmaceutical or biotech industry drug development experience with 3 + years experience directly managing M.D. peers.
• Noted disease expert with credibility to interface with key external health organizations (i.e. FDA, Advisory Committees, Therapeutic Area Experts, reporters, analysts, WHO etc.)
• Experience leading the design, conduct, analysis, and reporting of clinical studies, including successful IND or BLA/NDA filing experience and in-depth understanding of Phase II – III drug development
• Thorough understanding of US, EU and global regulatory authority requirements
• Strong interpersonal, influencing, presentation, and communications skills (written and verbal) to effectively address all levels within an organization