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, such as MD, PhD, Pharm D, MS, or MBA. 

Experience and Complexity by Level 

Criteria for Executive Director 

Large country and/or cluster / high-complexity geography 

Experience in Clinical Trials** - 10 years or more 

People Management Experience - 5 years or more 

** Clinical Trial Operations Experience 

Experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s), and/or a Sponsor environment working on multi-phase, multi-therapeutic, and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation. 

Additional 

Manages a team of 6-12 employees (direct reports). 

Required Skills:

Adaptability, Budget Management, Clinical Research Organizations (CRO) Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Ethical Standards, ICH GCP Guidelines, Mentorship, People Leadership, Resource Allocation, Results-Oriented, Risk Management, Strategic Thinking

Preferred Skills:

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

09/29/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.