AVP Head of Region, Clinical Trial Operations, EEA

Job Description

Associate Vice President, Head of Region Clinical Trials, EEA

The Regional Head manages all aspects of clinical trial operations in the region and reports to the Global Head of Global Clinical Trial Operations (GCTO) Regions. This position is responsible for execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and Clinical Research Organization (CRO) run studies. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is responsible for trial quality and audit responses and completion of Corrective and Preventive Action (CAPAs). The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the region, sub-region/clusters and individual countries. The position has multiple touch points with GCTO and staff in the US Research headquarters, or in the Global Clinical Development (GCD) regional office. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. The Regional Head represents the GCTO organization both internally and externally within the industry.

Primary activities/responsibilities:

• Provide Leadership to the Region, including continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management, and oversight of all high priority programs and studies. Participate and support the goals and objectives of the GCTO Senior Leadership Team (SLT) or extended Leadership Team (eLT).
• Manage Clinical Operations activities and personnel within the Region, Regional Country and Cluster Directors, and their respective staff to ensure compliance, quality, and timeline objectives are met for all trials executed in the region.
• Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM) and regional Quality Managers, to deliver objectives.
• Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate and appropriate resourcing for the Company’s internal clinical trial portfolio.
• Collaborate with Clinical Research Organization (CRO) Senior Leadership to ensure the successful implementation of fully-outsourced clinical trials as needed.
• Work with the Global Trial Optimization group within GCTO and Global Medical Directors in site management and selection decisions. Provide input into protocol design, feasibility, and resource assessments.
• Support the development and management of Investigator relationships in conjunction with the research organisation’s Therapy Areas, Global Clinical Development, and when appropriate, Human Health colleagues.
• Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
• Represent GCTO and the Regions on strategic initiatives at all levels of the organization, providing leadership as a member of the extended GCTO Senior Leadership Team.
• Ensure appropriate scientific and operational training for staff members.

Reports to: Global Head GCTO Regions

Extent of Travel: Up to 50%

Qualifications, Skills & Experience:

• An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS) is preferred or, at minimum, a Master’s Degree in a life science combined with a proven track record of contribution to and delivery of clinical trials.
• 10-15 years of experience in clinical operations, preferably in a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• Strong Leadership skills that will attract, motivate, inspire, develop and retain talented staff.
• Significant Management experience in a Clinical Trials setting, with the ability to service and collaborate with different stakeholders within GCTO.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong Communication skills requiring proficiency in written and spoken English.
• Proficiency in local languages is an added advantage, but not a pre-requisite.

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Employee Status: Regular

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Travel Requirements:

Flexible Work Arrangements: Hybrid

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Job Posting End Date: 02/24/2025

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