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:

Current Employees apply HERE

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

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