GCO EMEA Western Europe cluster Head (France, Germany, Italy, UK, Spain, Belgium and the Netherlands)-00000JUX
Senior Clinical R&D Director of Global Clinical Operations EMEA Western Europe (WE) France, Germany, Italy, UK, Spain, Belgium and the Netherlands is responsible for
– flawless trial execution within the EMEA WE zone and
– optimizing productivity by building synergies between the EMEA WE countries, improving processes and
– defining a long term sustainable strategy for EMEA WE in terms of trial execution and development of talent and leadership.
He/she will have to closely work with the EMEA WE country R&D directors and their teams to ensure these responsibilities and to guide the GCO teams through the process of change in line with EMEA WE strategy, the GCO strategy and the JEDI strategy.
All clinical trials are conducted according to international and national regulations, Company’s SOPs and Guidelines for Good Clinical Practice and ICH.
He/she is also responsible for the talent development, performance management and overall development of the employees working in the local GCO organizations, including succession planning and development of the local GCO EMEA WE organization. He/she should ensure full alignment of GCO EMEA WE objectives with the objectives defined by the Global Clinical Operations head in EMEA region and worldwide. He/she represents GCO EMEA WE at the European Management Team (EMT).
Place in the organization
Senior Clinical R&D Director is the head of the GCO organization of the following countries in EMEA: France, Germany, Italy, UK, Spain, Belgium, and the Netherlands. The EMEA Western Europe GCO head reports directly to the EMEA Regional head. This position will be a member of the EMEA Management Team (EMT).
Country R&D Directors/Managers of the EMEA WE countries will report directly to the WE Cluster head.
Tasks and Responsibilities
– Define long term strategy for the EMEA WE countries aligned with the GCO strategy as reflected in the ‘GCO house’ and with JEDI in order to position EMEA WE countries to achieve success outlined in Janssen 2020.
– Build strong relationships with EMEA and local medical affairs leadership as well as with local country management.
– Familiarize with their respective strategies and initiatives and build synergies to optimize the GCO EMEA WE organization to deliver on the projects and upon their expectations
– Build strong relationships with TA, ED and MA global leadership, familiarize with their respective strategies and initiatives, and build synergies to optimize the GCO EMEA WE organization to deliver on the projects and upon their expectations.
– Build and maintain strong relationships with EMEA Regional Therapeutic Area Experts (RTAEs), peer regional leads in EMEA as well as with GCO Central Trial Coordination (Early Development, Late Development and Medical Affairs) to ensure we deliver on our portfolio in the most efficient way.
– Set, translate, and be accountable for EMEA WE objectives in alignment with European and the global R&D organization.
– Ensure that the objectives of Country Directors/Managers are achieved (flawless execution of clinical trials within the timelines and budget)
– Manage, evaluate the performance and development of direct reports and build a strong talent pipeline
– Ensure correct application of the worldwide-harmonized Good Clinical Practice principles for the conduct of clinical trials as well as correct implementation of the GCO SOPs and any possible applicable regulations.
– Represent GCO at local HAs and any other relevant institutions.
– Identify and manage local external resources (CROs, Flex, contractors)
– Ensure clinical trial projects are sufficiently resourced (internal headcount and in-sourced co-workers)
– Ensure all employees in the EMEA WE zone receive the training they need for their function.
– As member of EMT be an important senior contact for the therapeutic Areas, Early Development organization and medical affairs and local operating companies:
– Ensure feasibilities are done and results communicated in a timely fashion to the teams
– Ensure country-specific requirements are properly communicated to the teams
– Inform the teams about resource availability and possible cost implications
– Track country performance
– Ensure pro-active identification of issues, problems and timely communication occurs to teams so that appropriate solutions can be solved.
– Manage and continuously seek to adapt, improve and support GCO’s clinical trial processes
– You have obtained at least a Master’s degree (a Phd is an asset) and have at least 9 years of business experience
– You are willing to travel (up to 25%)
– You have experience in managing people or leading teams
– You have at least 5 years of experience in clinical trials and R&D
– You have experience in working in a matrix organization and are familiar with change management.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D