Leads the Global Clinical Development (GCD) Team, a cross functional, multiunitional team of internal experts, through clinical phase II – III trials, global product registration, and ICMP trials supporting product life cycle optimization. Sets project-related objectives with GCP team members and provides input to their annual performance evaluation (PMP completed by the functional line manager). Requests GCD team members and clarifies resource availability with global functional heads.
• Member of the Global Project Team representing GCD and member of the Global Brand team, representing GCD
• 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. 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 Head of the Therapeutic Area (TA) and GPL, 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). Prepares assessments and recommendations at Decision Points, and presents them together with the Global Project Leader (GPL) to the Development Management Committee.
• Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (ISE, ISS, expert report). Consults with GCPPL, GIAPL (Global Integrated Analysis Project Leader), Global Regulatory, Medical Science Physician, GDS. 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 together with the Marketing Manager/SNPM Manager 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.
• Provides medical assessment of in- and out-licensing opportunities of development projects
• Approves domestic study concepts to ensure compliance with global strategy. Allocates studies to the D&C countries together with the global heads of Clinical Operations and Biometry, including patronage countries as needed.
The incumbent is a highly successful M.D. with extensive professional and academic experience. Board certification in a relevant therapeutic area is preferred but not a must. Key competencies needed by the candidate include the following:
• Proven leadership, motivational and interpersonal skills
• In-depth understanding of the drug development and commercialization process with a base of experience of 5+ years in Medical Science and drug development (From protocol writing to MRR).
• Must provide clear vision, direction, and purpose in the different cultures present within the global Medical 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 allinvolved parties. A matrix structure requires additional skills ingathering decision information, negotiation and communicating decisions and action
Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively