Head of Regional Clinical Operations Global Medical

il y a 1 mois

BoulogneBillancourt, France Ipsen Pharma (SAS) Temps plein

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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 **Head of Regional Clinical Operations Global Medical** is accountable to lead the team of Regional Clinical Operations Leads to ensure excellence in execution (i.e. project management, feasibility, oversight, compliance) within the regions of all evidence generation activities:

- ** Acting as a point of contact for Local Medical Affairs** to facilitate and support collaboration between Global Medical Clinical Operations.
- ** This role will lead some regions directly and/or allocate regions to the relevant Regional Clinical Operations Lead**, adjusting activities depending on the infrastructure locally in each region.
- ** For Global Medical,** this role is also accountable for applicable global vendor oversight activities within the regions, for example co-monitoring and building strong collaboration with MSL teams within the regions to facilitate enrolment/delivery of global evidence generation activities.
- ** For Local Medical, **this role provides guidance and advice to local teams to ensure overall governance and compliance in execution of evidence generation activities.

**Main responsibilities**:
**Regional Clinical Operations Leadership (Head of only)**
- Work with internal stakeholders globally and locally to ensure excellence in execution of all evidence generation activities in the regions
- Ensure relationship with sites/KOLs/HCPs are maintained and managed in relation to Global Medical Clinical Operations in conjunction with global and local teams
- Collaboration with GMA Clinical Operations Leadership team, and Senior Clinical Project Managers to ensure connectivity and alignment in priorities, delivery and excellence.
- Take overall line management responsibility

**For assigned regions;**
- Act as project manager to oversee local evidence generation activity within allocated regions
- Provide expertise in GCP or RWE data generation regulations, or in specific therapeutic areas, in order to assess the operational pertinence of considered clinical study design.
- Serve as Regional point of contact for Global Medical Evidence generation activities
- Co-monitor Global Medical Affairs clinical studies according to the oversight monitoring plan
- Review and input into local/ regional proposals/documentation to be submitted to Evidence Generation Review Board

**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 **. **Strong knowledge **Good Clinical Practice (GCP) and non-GCP data regeneration regulations**.

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