Roche is working to discover and develop transformative medicines for patients with major diseases of the nervous system including neuro-degeneration. Presently we are focused on Alzheimer's disease, Parkinson's disease, Huntington’s disease and amyotrophic lateral sclerosis (ALS), as well as other rare diseases. Gantenerumab is a humanized monoclonal antibody that binds to fibrillary amyloid-beta (Abeta). Abeta is the main constituent of amyloid plaque in the brains of patients with Alzheimer's disease and may be causative in the development of the disease. Gantenerumab has been shown to promote the clearance of amyloid in the brains of AD patients. We have a large, global Phase 3 clinical program underway to test safety and efficacy in prodromal to mild AD, and our program is growing. The new Group Medical Director, Gantenerumab will be responsible for strategic global clinical oversight of some of the planned new efforts for Gantenerumab. The position will involve clinical development of Gantenerumab in Alzheimer’s disease, including aspects of both early and late phases of development. In addition to leading a clinical development team, the Group Medical Director will be responsible for oversight of the design, implementation, monitoring, analysis, and reporting of studies as well as interactions with outside collaborators.
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 Gantenerumab – including the clinical development plans and implementation of studies, and leadership role in health authority interactions.
Closely collaboration with early development groups to define opportunities to explore new areas of scientific discovery
Strategic support for Late-Stage partnering for opportunities in neuroscience
Evaluate approved and late-stage PDN molecules for new indication opportunities
Noted disease expertise with credibility to work with key partners including external health organizations (i.e. FDA, Advisory Committees, Key Opinion Leaders, reporters, analysts, WHO etc.)
Coach, mentor, lead, and support employees to achieve business goals. Actively lead talent and career development.
Qualifications:
We are looking for a professional with M.D. or M.D./Ph.D., board certified or eligibility in Neurology. With expertise in clinical drug development (required) and 5+ years of pharmaceutical or biotech industry drug development experience.
3 + years of experience directly leading M.D. and clinical scientist peers required.
Validated 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
Detailed understanding of US, EU and global regulatory authority requirements
Significant successful interactions with key opinion leaders/investigators
Collaborative leadership for making decisions encouraging others to work together, and fostering creativity and innovation.
Capacity to lead, engage, and inspire a diverse group of clinical scientists and physicians.
Ability to efficiently work in a cross-functional/matrix environment and successfully impact external partnerships.
Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Development