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  • ID
    #8446497
  • Job type
    Full-time
  • Salary
    TBD
  • Source
    Biogen
  • Date
    2021-01-16
  • Deadline
    2021-03-17

Vacancy expired!

Job Description

The Medical Director, Clinical Development, Immunology, will leadand overseethe clinical development of assigned immunology assets. Reporting to the Executive Director, Clinical Development, Immunology, the position is responsible for the development and implementation of the Clinical Development Strategy for the assigned assets, including clinical study design and execution, as well as interpretation of study data. The individual in this role will interact with multiple functions and management within Biogen, and with external stakeholders including the global medical expert community, global regulatory authorities and vendors.

The Medical Director will have the following responsibilities:

  • Providemedical and strategic leadership for programs that integrate extensive knowledge in clinical science and immunology, and inputs from the global medical community
  • Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid strategic framework for the Clinical Development Plan (CDP)
  • Establishes appropriate clinical development timelines, incorporating key decision points for the CDP
  • Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels
  • Develops and maintains relationships with program counterparts in Commercial, Research, Early Clinical development, Regulatory, Clinical Operations and Statistics
  • Acts as the primary Clinical Development interface with internal stake holders as well as external KOLS and regulatory authorities for the assigned programs
  • Contributes to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development

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Qualifications

Education: MD, and/or PhD, ideally focused in dermatology, rheumatology or immunology

The ideal candidate will have the following professional and personal characteristics:

  • Minimum 5 years of experience in leading clinical development programs in the pharmaceutical industry with a proven record of achievements
  • Significant interaction with global regulatory authorities
  • Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment
  • The ability to lead directly and by influence, including strong problem solving, conflict resolution and analytical skills in a matrix environment
  • Excellent communication skills (oral and written) and excellent organizational skills
  • Experience in business development (due diligence) is preferred

Additional Information

The Medical Director, Clinical Development, Immunology is responsible for the development and implementation of the Clinical Development Strategy for the assigned assets, including clinical study design and execution, as well as interpretation of study data.

Vacancy expired!

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