8 days ago on roche.com

Associate Medical Director

Roche AG

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Associate Medical Director

Associate Medical Director

Switzerland, Basel-Town, Basel

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  The Associate PD Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s).  Associate PD Medical Directors participate in health authority (HA) interactions with supervision from more experienced PD Medical Directors.

 

  • Participates in the relevant Clinical Science Team (CST) activities and responsibilities
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • Collaborates 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, regulatory, business development, commercial operations, legal, etc. Development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.  Includes developing label and packaging language, etc.
  • Completes other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines