Provide oversight and leadership for GM Clinical Operations on the Integrated Evidence Generation (EG) Plan(s) to ensure strategic input, guidance advice and subsequent successful delivery.
Provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing for any EG, globally and locally, within therapeutic area of responsibility (from early planning & validation to full execution as applicable).
Review protocol / program plan and input into design and strategy, to ensure achievement of clinical and data generation excellence.
Be a referent & key contact point and representative for all GM clinical related activities for Therapy Area vis-à-vis TA Medical Directors, Head of Regional Clinical Operations, Finance, Legal, Procurement, PV, QA, cross-functional taskforces.
Provide clinical and operational expertise/guidance to CLINICAL PROJECT MANAGERS, CLINICAL TRIAL ADMINISTRATORs under his/her responsibility in the conduct of EG activities to meet the project objectives, to achieve the key milestones in terms of quality, performance and cost.
Review and input into operational feasibility to ensure execution, timelines, resourcing, and budget assessments are appropriate to meet study/program objectives (from high level feasibility and continual review thereafter).
Requirements
Strong line management experience
Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs.
Strong and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
Extensive experience and know-how in Oncology or in Rare Diseases or in Neurosciences.
Proven track record of delivery of projects to time, budget and quality.
Extensive track-record of interactions with country Medical Affairs Staff is a significant plus.
Exceptional leadership and influencing skills.
Fluency in English.
Benefits
Employee Care: We care for our employees, who are the ambassadors making a real difference.
Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
Job title
Therapeutic Area Director – Global Medical Clinical Operations
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