Job Description

• Provide Leadership to the Region. This includes 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. Adhere to Company standards and R&D/GCD and GCTO goals, initiatives and expectations. Participate and support the goals and objectives of the GCTO Senior Leadership Team (SLT) or extended Leadership Team (eLT). Speak with “one voice” on agreed strategies.
• Manage Clinical Operations activities and personnel within the Region, Regional Country and Cluster Directors, and their respective staff. Ensure that 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 as appropriate, in site management and selection decisions. Provide input into protocol design, feasibility, and resource assessments as appropriate.
• Support the development and management of Investigator relationships in conjunction with the R&D Therapy Areas, Global Clinical Development and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
• 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. Provide leadership to the GCTO organization as a member of the extended GCTO Senior Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and R&D objectives. Set clear performance standards and holds self and organization accountable for achieving results. Embrace GCTO metrics and performance standards (KPI’s)
• Responsible for ensuring appropriate scientific and operational training for staff members.