Clinical Research Director

Job Description The Clinical Research Director serves as the Clinical Operations lead for a country or cluster of countries and is responsible for the execution of all clinical trials within the scope of the Global Clinical Trial Operations country organization. This leader ensures trials are conducted to high quality standards and are inspection ready, in accordance with Good Clinical Practice guidelines, as well as local and global policies and procedures. The role is accountable for trial quality, audit responses, and completion of corrective and preventive action plans. The Clinical Research Director provides a single point of contact for clinical trial execution across all studies and phases within the assigned country or cluster and collaborates broadly across the organization depending on country and study needs. Key Responsibilities Strategic Leadership - Partner with regional leadership to shape and deliver the country or cluster strategy that meets the global clinical research pipeline needs. - Represent the country or cluster in strategic initiatives across all levels of the organization. - Build and lead a high‑performing team with the right capabilities to deliver the clinical portfolio across therapeutic areas and achieve agreed objectives for Global Clinical Trial Operations, Global Clinical Development, and the company’s Research Laboratories. - Lead the strategic development and management of relationships with institutions and investigators in partnership with Global Clinical Development and the company’s Research Laboratories therapy area teams, and when appropriate, with Human Health colleagues. - Co‑develop and execute the Global Clinical Trial Operations strategy for the country or cluster in collaboration with regional and global colleagues, including engagement with industry associations. People and Organizational Leadership - Recruit, hire, and retain top talent. - Proactively develop and manage team members through coaching, feedback, and performance management. - Identify capability gaps and emerging needs; address them via resource reallocation, targeted training, and/or external hiring. - Foster an empowering, compliant, collaborative, and innovation‑focused culture. - Build a culture of quality and compliance through training, oversight, and cross‑functional collaboration. - Ensure appropriate scientific and operational training for all staff. Clinical Operations Management - Ensure a single point of accountability for end‑to‑end clinical trial execution across all studies and phases within the country or cluster. - Provide leadership and oversight of objectives and initiatives for the company’s Research Laboratories, Global Clinical Development, and Global Clinical Trial Operations. - Develop and deploy company standards within the assigned geography. - Oversee activities of country/cluster clinical operations teams across all programs and studies. - Approve administrative budgets (e.g., salaries, travel) and country‑level operational study budgets. - Coordinate regulatory inspections and internal audits; respond to health authorities, ethics committees, and internal auditors in partnership with Country Clinical Quality Management, Compliance, Regulatory Affairs, Pharmacovigilance, and Medical Affairs. - Develop audit responses and timely completion of corrective and preventive action plans. - Collaborate with functional service provider leaders and clinical research organization leaders to ensure appropriate resourcing for the internal clinical trial portfolio. - Support study management and clinical operations for trials led by Global Clinical Trial Operations. Engagement With Key External Stakeholders - Build and manage investigator and institutional relationships in partnership with therapy area teams and, when appropriate, Human Health colleagues. - Contribute to program life‑cycle management through effective study allocation and execution, including prioritisation and collaboration with key opinion leaders. Quality, Compliance, and Standards - Ensure all trials in the country meet compliance, quality, and timeline objectives. - Set clear performance standards and hold self and team accountable for results; embrace Global Clinical Trial Operations metrics and key performance indicators. - Work collaboratively in a matrix environment with groups across Global Clinical Trial Operations, especially Clinical Sciences and Study Management, Clinical Quality Managers, and Regional Operations teams, to deliver objectives. - Take responsibility for clinical audits, working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council. Qualifications Required - Bachelor’s degree in a scientific discipline or equivalent healthcare experience. - Significant management experience within clinical trials, with demonstrated ability to serve and collaborate with diverse stakeholders in a matrix organization (e.g., Clinical Operations, Global Clinical Development, Research Laboratories). - Proven expertise managing budgets, travel, resources, headcount, processes and controls, productivity, quality, and project delivery. - Comprehensive understanding of ICH Good Clinical Practice guidelines and global, regional, and local regulatory requirements. - Strong written and verbal communication skills in English; proficiency in local language preferred. - Strategic thinking capability and sound decision‑making. Preferred - Advanced degree (e.g., Medical Doctor, Doctor of Philosophy, Doctor of Pharmacy, Master of Science, Master of Business Administration). Behavioral Competencies - High emotional intelligence. - Strong, inspirational leadership that attracts, motivates, develops, and retains talent. - Demonstrated success in people management and in driving alignment with the goals, purpose, and mission of the company’s Research Laboratories, Global Clinical Development, and Global Clinical Trial Operations. Experience - 5–10+ years of experience in clinical trial operations, gained in hospitals or research institutions, recognised clinical trial vendors, reputable contract research organisations, and/or sponsor environments, spanning multiple phases, multiple therapeutic areas, and diverse study types from initiation to closeout, including regulatory submission and inspection preparation. - 3+ years of people management experience. Role Context and Complexity - Scope typically covers a mid‑sized country or a mid‑complexity geography, considering factors such as country/affiliate size and team size, product portfolio and clinical pipeline, local research ecosystem and volume of local data generation and investigator‑initiated research, market access and healthcare policy environment. Required Skills Accountability, Adaptability, Clinical Quality Management, Clinical Research, Clinical Site Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Operations, Decision Making, Emotional Intelligence, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, Leadership, Management Process, Multiple Therapeutic Areas, People Leadership, People Management, Process Improvements, Professional Networking, Project Management, Regulatory Requirements, and additional relevant skills. #J-18808-Ljbffr