Therapeutic Area Director, Global Medical Clinical Operations

il y a 3 semaines

BoulogneBillancourt, France Ipsen Pharma (SAS) Temps plein

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

The Therapeutic Area Director, Global Medical (GM) Clinical Operations acts as an expert and is accountable within their allocated Therapeutic Area/Assets, represent GM Clinical Operations strategically in early planning of all global and local evidence generation activities (the IEGP), and provide oversight of the excellence in execution/delivery of those activities.

Main responsibilities:

  • Provide oversight and leadership for GM Clinical Operations on the Integrated Evidence Generation 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 task-forces.
  • 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)
  • Take overall line management responsibility for workload assessment, resource allocation, development, support, review, training and objective setting & performance assessment of all direct reports (CLINICAL PROJECT MANAGERS, CLINICAL TRIAL ADMINISTRATORs internalized and externalized).

Travel is to be expected within this role, as business needs require, and up to 25% of the time.

In order to be considered for this role you must have a significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.

Demonstrating a value-add capability and mindset to provide strong direct global leadership/project management . You will have exceptional communication and influencing skills. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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