Roche is working to discover and develop transformative medicines for patients with major diseases of the nervous system. Presently we're focused on neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS), as well as pain.
Semorinemab is a humanized monoclonal antibody, which binds to Tau protein. Tau is the main constituent of neurofibrillary tangles in the brains of patients with Alzheimer's disease and is proposed to be causative in the development of the disease.
The (Associate) Group Medical Director, Semorinemab will be responsible for strategic global clinical oversight of the Semorinemab development program. The position will involve clinical development of Semorinemab in Alzheimer’s Disease, and including aspects of both early and late phases of development. In addition to managing the clinical development team, the (Associate) Group Medical Director will be responsible for oversight of the design, implementation, monitoring, analysis, and reporting of studies.
- Broadly represent the interests of Product Development Neuroscience within Roche and Genentech, through interactions with Research, Biomarkers, Early Development, Medical Affairs, Commercial, Regulatory and Business Development senior leaders
- Accountable for the strategic clinical development of Semorinemab – 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
- Strategic support for Late Stage partnering for all opportunities in neuroscience
- Evaluate approved and late stage PDN molecules for new indication opportunities
- Noted disease expert with credibility to interface with key external health organizations (i.e. FDA, Advisory Committees, Key Opinion Leaders, reporters, analysts, WHO etc.)
- Coach, manage and support employees to achieve business goals. Actively manage talent and career development.
Candidates should have an M.D. or M.D./Ph.D. with board certification or eligibility in Neurology. Expertise in clinical drug development is required. 5+ years pharmaceutical or biotech industry drug development experience with 3 + years’ experience directly managing M.D. peers required. Demonstrated scientific expertise in Neurology and Alzheimer’s Disease.
- Experience leading the design, conduct, analysis, and reporting of clinical studies, including successful IND or BLA/NDA filing experience
- Thorough understanding of US, EU and global regulatory authority requirements
- Significant successful interactions with key opinion leaders/investigators
- Proven ability to manage, motivate and inspire a diverse group of clinical scientists and physicians.
- Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage external partnerships.
Roche is an equal opportunity employer.Research & Development, Research & Development > Clinical Development