YOUR TASKS AND RESPONSIBILITIES

• Leads the Clinical Development (CD) team, a cross functional, multinational team of internal experts, through clinical phase II - III trials and global product registration, as well as supporting product life cycle optimization
• Sets project-related objectives with Global Project Team (GPT) members
• In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower)
• Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources
• Analyses of incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate
• Responsible for communication of clinical development strategy and outcome of clinical projects including study results to internal and external bodies (e.g. regulatory authorities)
• 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 (IB)
• Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and defines the publication strategy together with Medical Affairs
• Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development
• Provides medical assessment of in- and out-licensing opportunities of development projects

WHO YOU ARE 

• The incumbent is a highly successful M.D. with extensive professional and academic experience
• Board certification in a relevant therapeutic area is preferred
• Proven leadership, motivational and interpersonal skills
• In-depth understanding of the drug development and commercialization process with a base of significant experience in medical science and drug development
• Must provide clear vision, direction, and purpose in the different cultures present within the global Clinical Organization
• Incumbent 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
• Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively
• Fluent written and spoken English language skills

Please note: This position can be filled in Wuppertal or Berlin

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