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.  
• Builds 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*
* • Ensures 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:  o    Objectives and initiatives for the company’s Research Laboratories, Global Clinical Development, and Global Clinical Trial Operations.  o    Development and deployment of company standards within the assigned geography.  o    Activities of country/cluster clinical operations teams across all programs and studies.  o    Approved administrative budgets (e.g., salaries, travel) and country-level operational study budgets.  o    Regulatory inspections and internal audits;

coordinate responses to health authorities, ethics committees, and internal auditors in partnership with Country Clinical Quality Management, Compliance, Regulatory Affairs, Pharmacovigilance, and Medical Affairs.  o    Development of audit responses and timely completion of corrective and preventive action plans.•   
** Collaborate with:
** o    Functional Service Provider senior, regional, and local leaders to ensure appropriate resourcing for the internal clinical trial portfolio.  o    Clinical Research Organization senior, regional, and local leaders 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 prioritization and collaboration with key opinion leaders.  Quality,…