Senior / Principal Medical Director Alzheimers Disease Clinical Development
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Our Clinical Development team has a fantastic opportunity for a Senior/Principal Medical Director to join the neurology franchise to support late-stage clinical studies. The key focus for this role would be on Trontinemab which is the first anti-amyloid antibody in trials to use brain-shuttle technology, which Roche and other companies have been developing for years.
The Senior/Principal Medical Director leads the development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient execution for assigned molecule(s)/indication(s). Principal Medical Directors are also expected to contribute CD expertise to the specific therapeutic (i.e. Neurology - Alzheimer’s disease) strategies and plans, including enhanced biomarkers and advanced imaging analytics development.
THE OPPORTUNITY
You will be responsible for the development and operational alignment of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s); You will act as the CDP lead and/or supervise the development of study analytics & data management plans.
You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.
You may participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late stage input to Phase I & II protocols.
You will lead or oversee others in development of briefing packages by providing clinical science information and input; Leads or oversees others in development of responses to HA questions by providing clinical science information and input; Leads or oversees others in health authority (HA) interactions.
You will play a lead role in educating others internally and externally on relevant clinical developments as these may implicate the assigned therapeutic area’s CDP strategies, plans and programs; You will help research and other groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals, including the ability to perform clinical assessments on relevant drug discovery projects.
WHO YOU ARE
MD Neurologist ideally specializing in geriatrics
Strong presence and relationships with KOLs in the field of neurodegenerative medicine
You have 8+ years of pharma/biotech R&D experience. Strong experience in late-stage drug development is essential.
Health Authority Interaction experience for pivotal trials in the US and Globally
You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills, proven ability to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.
?
If you are a Neurologist with experience in Alzheimer’s disease drug development and would like to be a part of a team that is committed to delivering transformational medicines to patients, we would love to hear from you.
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