Executive Clinical Research Director

Job Description Position Title (and Short Title) Clinical Research Director (CRD) Organization Details Global Clinical Trial Operations / Regions Brief Description of Position The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for 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. CRD is the primary country/cluster-level contact for GCTO and has the following key responsibilities: 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. Builds and leads the team to effectively manage resources, ensuring an appropriately skilled and high-performing team to deliver the portfolio across therapy areas and achieve agreed GCTO, GCD, objectives. Leads strategic development and management of institutional and investigator relationships in conjunction with / 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. Leadership and Management of the GCTO Country / Cluster Organization Recruits and hires talent. Proactively manages and develops talent. Proactively identifies new opportunities and gaps to support emerging needs and addresses them by reallocating and training 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. Provides oversight to ensure appropriate scientific and operational training for staff members. Clinical Operation Management Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies and phases in scope of GCTO within the country/cluster. Leadership and oversight of the following: / GCD / GCTO goals, initiatives, and expectations. Development and delivery of company standards in the given geography. Activities of all cluster/country-level GCTO teams and all programs and studies. Approved administrative budget to support the GCTO team, such as salaries and 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 for and supports development of audit responses and completion of CAPAs. Collaborates and supports: Functional Service Provider (FSP) senior, regional, and local leadership to ensure adequate and appropriate resourcing for the company internal clinical trial portfolio. Clinical Research Organization (CRO) senior, regional, and local leadership to ensure the successful conduct of outsourced clinical trials. Engagement With Key External Stakeholders 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 Therapy Areas, and, when appropriate, Human Health colleagues. Contribute to program life-cycle management through effective study allocation and execution, including prioritizing programs and working with Key Opinion Leaders (KOLs). Quality / Compliance Adherence / Standard 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 (KPIs). Work collaboratively in a matrix organization with all groups within GCTO, especially 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). Division/Area Clinical Operations Reports to GCTO Regional Research Director (RRD) for Latin America Extent of Travel Up to 30% Qualifications, Skills & Experience CORE Competency Expectations Significant management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO 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 regulatory requirements is required. Strong communication skills requiring proficiency in written and spoken English and preferably the local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking. Behavioural Competency Expectations High emotional intelligence. Strong leadership that will attract, motivate, inspire, develop, and retain talented staff. In addition, leadership skills that enable and drive alignment with the goals, purpose, and mission , Global Clinical Development (GCD), and GCTO. Positive proven success in people management. Educational Requirements Required: Bachelor’s degree in Science or equivalent healthcare experience. Preferred: Advanced degree