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Msd

Executive Clinical Research Director

LocationCOL - Cundinamarca - Bogotá (Colpatria)
Work modehybrid
Typefull-time
DepartmentClinical Operations
Company size10,000+ people
First seen6d ago
Last seen2d ago
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.
Responsibilities
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.
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Proactively manages and develops talent.
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Proactively identifies new opportunities and gaps to support emerging needs and addresses them by reallocating and training existing staff and/or external recruitment.
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Creates an empowering, compliant, collaborative, and innovation-focused work environment.
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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.
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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.
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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.
Nice to have
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:
Hiring process
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
*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.
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