Associate / Medical Director, Clinical Development, Immunology

Job Description

The new Associate / Medical Director, Clinical Development, Immunology, will leadand overseethe clinical development of assigned immunology assets. Reporting to a senior member of the Immunology, Clinical Development team, 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.

• 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

You are a proven leader within the Clinical Development, Immunology/Rheumatology space and strive on developing, executing and advancing a strategic and successful development program. You have experience managing high performing teams; providing the necessary guidance and mentoring for all to reach their goals.

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Qualifications

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

• Three (3) - Five (5) years of experience in clinical research with a proven record of achievement; including experienceleading clinical development programs in the pharmaceutical industry; significant industry experience is needed at the Medical Director level.
• 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 new Associate / 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.