Regional Head, Global Clinical Trial Operations, North America

About the position

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 exquisite 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 Research and Development (R&D) staff in the US 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. There are some interfaces with Global Human Health (GHH)/Value and Implementation (V&I). The Regional Head represents the GCTO organization both internally and externally within the industry.

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.
• 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.
• Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate resourcing for clinical trial portfolio.
• Support the development and management of Investigator relationships in conjunction with the R&D Therapy Areas.
• Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group.
• Represent GCTO and the Regions on strategic initiatives at all levels of the organization.
• Provide leadership to the GCTO organization as a member of the extended GCTO Senior Leadership Team.
• Ensure appropriate scientific and operational training for staff members.

Requirements

• 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 Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials.
• Strong Leadership skills that will attract, motivate, inspire, develop and retain talented staff.
• Significant Management experience in a Clinical Trials setting.
• Management expertise covering budget, travel, resources, headcount, processes, productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements.
• Strong Communication skills requiring proficiency in written and spoken English.

Nice-to-haves

• Business and financial management skills (e.g. MBA).
• An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS).
• Proficiency in local languages.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.