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YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Global Clinical Leader MD- Pulmonology, are to:
Lead the Global Clinical Development Team, a cross functional, multinational team of internal experts, through clinical phase II – III trials, global product registration, and trials supporting product life cycle optimization;
Set project-related objectives with Global Clinical Program team members;
Be a member of the Global Project Team and also of the Global Brand team representing Clinical Development;
In consultation with relevant key disciplines, prepare the Clinical Development Plan, including an operational plan with high level resource planning (timelines, budget and manpower);
Be responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and Clinical Research Organization management fees) and manpower;
Be responsible for the ongoing risk-benefit assessment of a compound until approval in main countries;
Analyze incoming clinical data, relevant medical and scientific information and initiate actions or decisions as appropriate;
In consultation with the Head of the Therapeutic Area and Global Project Leader, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities);
Prepare assessments and recommendations at Decision Points, and present them together with the Global Project Leader to the Development Management Committee;
Define the strategic approach and managing preparation of medical sections of key Regulatory documents;
Compile and maintain Investigators’ Brochures (IB);
Provide medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and define the publication strategy together with the Marketing Manager/Strategic New Product Marketing Manager;
Approve publications and ensure consistency of publications with clinical data and publication strategy;
Contribute to Opinion Leader development and publications strategy with implementation detail;
Establish and maintain appropriate external scientific advisory boards and assists in advocacy development;
Provide medical assessment of in- and out-licensing opportunities of development projects;
Approve domestic study concepts to ensure compliance with global strategy;
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
M.D. Degree with extensive professional and academic experience;
Proven leadership, motivational and interpersonal skills;
In-depth understanding of the drug development and commercialization process with a base of experience of at least 5 years in Medical Science and/or drug development;
Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization;
Must embrace change and be able to work in a changing environment;
Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties;
Skilled in gathering decision information, negotiation and communicating decisions and action;
Execute his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.
Board certification in Pulmonology or other relevant therapeutic area (such as internal medicine, critical care).
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