Executive Director, Global Clinical Trial Operations, Oncology

Job Description

The Executive Director (ED) is the Clinical Operations lead in a country/ cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (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.

ED 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.
• Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and Research and Development objectives.
• Leads strategic development and management of institutional & investigator relationships in conjunction with Research and Development/ 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 by reallocating and training of 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.
• 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 & phases in scope of GCTO within the country/cluster.

Leadership and oversight of the following:

• Research and Development/ GCD/ GCTO goals, initiatives and expectations.
• Development and delivery of company standards in given geography.
• Activities of all cluster/country level GCTO team & all programs and studies.
• Approved administrative budget to support GCTO team (e.g., salaries & 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 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 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 Research and Development Therapy Areas, and when appropriate Human Health colleagues.
• Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).

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 (KPI's).
• Work collaboratively in a matrix organization with all groups within GCTO, especially with 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).

Extent of Travel : up to 30%

CORE Competency Expectations:

• Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and Research and Development 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 local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.

Behavioral 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 of our company Research Labs, Global Clinical Development (GCD) and GCTO.
• Positive proven success in people management.

Criteria for complexity includes:

• Country/affiliate size
• Team size
• Product portfolio
• Pipeline and clinical trials
• Scientific research environment, number of local data generations, Our Company Investigator Studies Programs
• Access and healthcare policy environment
• Large country and/or cluster / high-complexity geography*

Educational Requirements:

• Required: Bachelor's degree in Science or equivalent healthcare experience
• Preferred: Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA)

Required Experience and Skills:

• 10 years or more experience in Clinical Trials
• 5 years or more people management 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 clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.

Preferred Experience and Skills:

• Demonstrated experience within Oncology.
• Demonstrated success leading large, global clinical trial start-up initiatives in a pharmaceutical or biotechnology environment.
• Experience with digital platforms and technology-enabled study start-up solutions.
• Experience managing personnel and processes in a matrix managed organization.
• Working with multiple external partners with adequate controls, governance, and oversight.

Required Skills:
Budget Management, Clinical Quality Management, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Executive Leadership, Good Clinical Practice (GCP), Oncology, People Leadership, Regulatory Requirements, Resource Allocation, Results-Oriented, Risk Management

Preferred Skills:
Clinical Trial Management

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$255,800.00 - $402,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:
25%

Flexible Work Arrangements:
Remote

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
03/24/2026
*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.

Requisition ID: R386691