Senior Director, France Country Head Clinical

il y a 3 semaines


RueilMalmaison, France GSK Temps plein

**Site Name**: France - Rueil Malmaison

**Posted Date**: Mar 16 2023

GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Key Responsibilities will be**:

- Accountable for strong leadership, people management, talent retention and development within the Clinical Operations Team in country, providing direction and vision. Translates the organisation vision, mission and strategy into coherent plans / requirements that can be understood and implemented by clinical research staff. This includes ensuring that all teams understand and operate according to the agreed business priorities, regulatory requirements and internal processes in order to ensure excellence in the delivery of studies and projects.
- Actively engages with local industry partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in the country.
- He/she drives, business efficiencies, implementation of new processes and quality improvement, facilitates sharing of best practices, learnings and expertise at a local, regional or global level where appropriate. This role contributes to the LOC’s immediate and long-term successes.
- Ensures the quality and integrity of clinical studies conducted in the LOC by implementing quality and risk management plans. Actively identifies and manages any internal and external risks to the business.
- Has oversight of LOC Business Continuity Plans (BCPs).
- Full operational and financial accountability for the clinical operations country budget.
- Promotes the profile and credibility of the department with internal groups with global clinical operations and beyond as well as external groups (hospitals, GP networks, physicians, HCPs, industry initiative groups etc) in order as well to develops operational strategies (12-18m months horizon) of an adequate network of clinical sites and other external partners (ethics committees, study support vendors, etc) to support local and global development needs in support of large portfolios.
- Ensures strategic local input is provided at early stages of clinical development planning to optimize study feasibility in-country, interacts with country medical director/Local Medical Leads and global project teams to contribute to the development of operationally robust clinical plans.
- Develops and implements a resourcing strategy (internal staff and/or external resources) to ensure availability and competency of resources needed to meet portfolio requirements and accountable for forecasting and management of country budget (IPE and EPE)
- Leads cross-country/cross regional projects and initiatives
- Ensures that key country feedback from LOCs and investigators is captured and shared with relevant internal stakeholders within clinical operations and R&D to inform the design and execution of the clinical portfolio

**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- University Scientific degree coupled with line and project management experience. Any general science degree e.g. life science, medicine, clinical research degree, pharmacy.
- Vast years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development, in a multidisciplinary environment.
- Demonstrated leadership experience in managing the delivery of a large and complex portfolio of time-critical activities preferably in a regulated environment.
- Excellent knowledge of ICH GCP and in depth knowledge of drug and vaccine development process.
- Excellent leadership skills with demonstrated ability to build and maintain highly efficient and performing teams in complex environments
- Excellent verbal and written communication, negotiation, presentations and relationship skills to drive business performances
- Business acumen and demonstrated ability to think strategically, quickly appreciate the differing perspectives in a given situation and achieve a win-win outcome

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- PhD or MD with substantial industry experience in Pharma/ Biotech R&D
- He/she is member of the regional and global in-country clinical operations network and has above country accountabilities to ensure R&D objectives are met.
- A strong sense of initiative, urgency, pragmatism, judgment - an ability to make things happen.
- Provide insight into related cross-functional R&D/Research projects.


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