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, 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 International Council for Harmonisation 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, recognized clinical trial vendors, reputable contract research organizations, 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:
o    Country/affiliate size and team size
o    Product portfolio and clinical pipeline
o    Local research ecosystem and volume of local data generation and investigator-initiated research
o    Market access and healthcare policy environment
 

Required Skills:

Accountability, 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 {+ 3 more}

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/30/2026

*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.