Senior Medical Director, Product Development, Neurology

About the role

The Senior Medical Director leads the development and execution of the Clinical Development (CD) strategy and plan for assigned molecules/indications, ensures cross‑functional integration and efficient CD plan execution, represents CD to internal Roche groups, collaborates with internal and external partners, leads health authority interactions and regulatory submissions, and trains new CST members.

Responsibilities

• Lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s)
• Represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups
• Ensure cross‑functional integration, coordination and alignment to enable effective and efficient CD plan execution
• Collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
• Participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance; includes reviewing and providing late stage input into Phase I and II protocols
• Lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input
• Take a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation; providing clinical science information and input for regulatory submissions and other regulatory processes
• Develop label and packaging language, etc.
• Be accountable for training new CST members

Requirements

• Board Certified/Board Eligible (or its equivalent) MD (MBBS),