27 days ago on roche.com

Medical Director Autism

Roche AG

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 Please refer to JobSuchmaschine in your application

Medical Director Autism

Medical Director Autism

Switzerland, Basel-Town, Basel

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  • Job facts

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 PD Medical Director participates in development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s).

  • Participates in and/or leads the relevant Clinical Science Team (CST)
  • 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, business development, commercial operations, legal, etc.
  • Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:
  • Guides CST and relevant sub-teams in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
  • Provides clinical oversight across all relevant studies and programs.and designs and develops clinical studies
  • Works with 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
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
    • A medical doctor in neurology with 4 or more years pharma/biotech industry experience in autism OR is a recognized expert in the field of autism
    • 4 or more years experience with clinical trials. In-depth understanding of Phase II – III drug development and experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
    • Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
    • Experience publishing results of a clinical drug trial in a referred journal is preferred
    • Academic/teaching background is a plus
    • Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Development
    • Subfunction Clinical Development
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Date 2016/09/26
    • Job-ID 3241375048
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