Job Information
J&J Family of Companies Vice President, Regional Head EMEA GCO in Basel, Switzerland
Vice President, Regional Head EMEA GCO - 2406184092W
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Position Summary:
VP GCO EMEA provides the leadership and direction to the Global Clinical Operations organization within the EMEA Region, providing end to end site-facing operational capabilities with key goal of delivering our clinical development programs on time and on budget. The GCO organization functions as the primary connection between our Clinical Development Teams and the 6000 clinical research sites that conduct Johnson and Johnson (J&J) Clinical Trials. They are the face of J&J to the majority of investigators and ensure that the trials are conducted in a GCP-controlled way but with a patient-and site-centric mindset.
The VP GCO EMEA is responsible and accountable for Trial Coordination and Site Management activities within the EMEA region, across 24 core countries along with the Sub-Saharan region of Africa. This includes but is not limited to oversight, leading, driving, and providing strategic direction to the clinical trial coordination and execution process in conformance to all relevant laws, regulations, guidelines, policies, and procedures.
This is accomplished through leading a large and diverse team of 1500 associates (Headcount and Flex), with responsibility for $170M budget. Additionally, this individual will establish appropriate connections with appropriate partners to ensure overall portfolio success e.g. CROs.
As a GCO Leadership Team (LT) member, this role is involved in strategic and operational management and decision-making within GCO, needs to provide regional input and leadership, and lead/support key Global Development (GD) and GCO initiatives or projects.
Finally, the VP GCO EMEA, acts as a board member of JCI. Whilst Janssen-Cilag International NV (JCI) relies on the different R&D, marketing & sales and support organizations for its products for which it is sponsor or Marketing Authorization Holder (MAH), its board is composed of senior European representatives of these respective groups.
Principal Responsibilities:
Drives the needed design input, planning and execution for clinical trials in his/her region. This includes the effective protocol feasibility input and site selection, and the monitoring of the clinical trial execution including milestone achievements, budget, and quality.
Designs the regional organization so that execution of clinical trials by the employees in the EMEA region is done according to protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
Helps shape and communicates the GCO vision through regional leadership and alignment by building an informed, aligned, and engaged workforce. Ensures alignment of the regional objectives with the overall targets and objectives of the GCO and Global Development.
Is accountable for the regional annual budget process and prioritizes resource needs. Communicates anticipated projects, clinical trial plans, and additions to staff. Approves final budget. Oversees workload for the staff to ensure optimal utilization rate of resources throughout the region.
Creates strong working relationships with critical business partners within and outside GCO and catalyses his/her organization to do the same.
Accountable for building a high performing team through on-going development, performance management and coaching. Takes ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process.
Identifies strategic improvement opportunities, and sponsors/leads/contributes to critical improvement projects for GCO.
Reports back to LT about regional performance, issues, communicates and ensure implementation of GCO LT decisions that impacts on the region.
Keeps the JCI board well informed on any relevant issues and ensure appropriate oversight is provided through the JCI compliance office. Responsible and accountable for implementation of decisions taken at the JCI board that impact on JCI sponsored clinical trials executed by Global Development in the region.
Principal Relationships:
This position reports to the Head, Global Clinical Operations. The position supervises a large regional team of more than 1500 associates (J&J and flex staff) globally and has 6-8 direct reports, at Director and Senior Director level.
Contacts in the organization: Other Regional GCO Leaders, Contracts and Centralized Services (CCS), Delivery Units (DU), R&D/Local Operating Company and departments, Clinical Supply Chain (CSC), Quality & Compliance Groups, R&D Operations Functions, External vendor groups, Medical Affairs.
Contacts outside of the organization: CRO Functional Management, Ethics Committees, Health Authorities, Investigational Sites, and others.
Qualifications
Education and Experience Requirements:
Master’s degree (scientific or business orientation) preferred; advanced scientific degree preferred.
At least 15-20 years of experience in relevant Clinical Operations / Operations / Commercial functions across career, with exposure to clinical development teams/process (from PI-PIV through filing).
Strong knowledge in regulatory and operations compliance and quality control experience.
Proven track record of delivering complex, global clinical programs - Strong knowledge in regulatory and operations compliance and quality control experience.
Experience driving performance through external partnerships, specifically in the areas of CROs, FSP and Central Labs.
Global and diversity-oriented people management experience including line management and matrix management. Experience with working in or with truly global and multidisciplinary R&D teams.
Expert knowledge of clinical operations processes, from protocol development to submission across all phases of development (including Medical Affairs). Experience in multiple TAs.
Foundational knowledge in the areas of Finance and Data Science.
Change management/leadership experience in driving complex transformation efforts.
Excellent interpersonal and communication skills. Demonstrated ability to influence decision making at all levels. Able to positively impact productivity and business results.
Ability to develop strong partnerships in a matrix environment.
Fostering a culture of accountability and empowering others.
Driving a Credo-based culture, including a diverse and inclusive work environment.
Demonstrated inspirational leadership and ability to set a vision for the future; a drive for delivering and exceeding business results.
Proven ability to act as a change agent and adapt to rapidly changing organizational and business issues.
Location:
The position is based in Beerse, Belgium or Allschwil, Switzerland and will require 15-20% domestic and international travel as needed.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization Janssen Pharmaceutica N.V. (7555)
Job Function Clinical/Medical Operations
Req ID: 2406184092W