Executive Director, Global Clinical Trial Operations, Oncology

Job Description

The Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (GCTO) country operations.

Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster.

The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.

• Supports the regional GCTO leadership team, leading strategic development of their country/cluster to deliver clinical trials as per global clinical research pipeline requirement.
• Strategic country/cluster representative for initiatives at all levels of the organization.
• Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and Research and Development objectives.
• Leads strategic development and management of institutional & investigator relationships in conjunction with Research and Development/ GCD Therapy Areas, and when appropriate Human Health.
• Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations.

• Recruits and hires talent.
• Proactively manages and develops talent.
• Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment.
• Creates an empowering, compliant, collaborative, and innovation-focused work environment.
• Builds a culture of quality and compliance through training, oversight, and collaboration.
• Oversight to ensure appropriate scientific and operational training for staff members.

Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.

• Research and Development/ GCD/ GCTO goals, initiatives and expectations.
• Development and delivery of company standards in given geography.
• Activities of all cluster/country level GCTO team & all programs and studies.
• Approved administrative budget to support GCTO team (e.g., salaries & travel).
• Country level operational study budgets.
• Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs.
• Responsible and supports development of audit responses and completion of CAPAs.

• Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio.
• Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the successful conduct of outsourced clinical trials.

• Supporting Management and the clinical operations of studies managed by GCTO.
• Support the development and management of Investigator and operational relationships in conjunction with all Research and Development Therapy Areas, and when appropriate Human Health colleagues.
• Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).

• Ensure that compliance, quality and timeline objectives are met for all trials executed in the country.
• Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s).
• Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional Operations Teams, to deliver objectives.
• 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).

up to 30%

• Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and Research and Development in a matrix organization.
• Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local…