Job Senior Medical Director Neuro

Senior Medical Director, Biotech

As a Senior Medical Director, Biotech you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing :

• Leads the Clinical Development Team, a cross functional, multinational team of internal experts, through clinical phase II III trials through global product registration, as well as supporting product life cycle optimization.
• Sets project-related objectives with Global Project Team members and provides input to their annual performance evaluation. Requests CD team members and clarifies resource availability with global functional heads.
• Member of the Global Project Team and member of the Global Brand team, representing CD.
• In consultation with relevant key disciplines, prepares the Clinical Development Plan, including an operational plan with high level resource planning (timelines, budget and manpower). Responsible for planning and managing the clinical timelines, managing clinical budget and manpower against the approved CDP and approved resources. Proactively initiates corrective action as needed.
• Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
• In consultation with the Nucleus Head, Global Clinical Program Excellence Leader and relevant Product Team members, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies. Prepares assessments and recommendations at Decision Points and presents them together with the GPL to the Development Management Committee.
• Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents. Compiles and maintains Investigators' Brochures.
• Provides medical expertise to Global Strategic Marketing and Strategic New Product Marketing and defines together with Medical Affairs the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail.
• Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.
• Provide medical assessment of in- and out-licensing opportunities of development projects, foster patient-centric trial designs, and consider patient involvement in clinical development and trial design planning.
• Approves domestic study concepts to ensure compliance with global strategy.

Qualifications

You are :

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