The Regional Operations Head (ROH) acts as Chief of Staff to the Regional Head, GCTO Region (RRD), providing end-to-end business and portfolio oversight to ensure performance, quality, and compliance across regional programs and protocols. The ROH plays a critical role in supporting strategy development with the RRD and regional leadership team to drive high performance aligned with strategic and operational goals.
The individual must have the following core competencies in operational excellence:
Driven, Strategic Thinking & Business Acumen, Change Champion, and Proficient in AI Fluency, and Data Analytics.
Key Responsibilities:
Chief of Staff & Portfolio Oversight:
Support the RRD and GCTO Region by facilitating cross-functional meetings to align teams on project goals, timelines, and deliverables.
Prepare dashboards, status reports, and materials to communicate progress, risks, and issues to leadership.
Act as liaison between RRD, Clinical Research Directors (CRDs), regional teams, and key stakeholders including our Research & Development Division and Human Health (HH) to clarify priorities, resolve conflicts, and ensure alignment on critical GCTO issues.
Track key milestones, dependencies, and resource gaps, proactively identifying risks and driving follow-up actions to ensure accountability and timely execution.
Develop and manage the regional project portfolio, tracking realization goals and using data to analyze and propose mitigation strategies.
Identify inefficiencies and propose process improvements to enhance operational effectiveness.
Regional Trial Allocation & Clinical Research Strategy:
Oversee regional clinical trial allocation, coordinating allocation proposals and engaging stakeholders across functions to build a comprehensive knowledge base at capability, therapeutic area, scientific, and strategic levels.
Collaborate with GCTO regional/country leadership, and other key stakeholders in region to develop and align clinical research strategies with long-term regional and corporate objectives.
Partner with regional support roles to define, track, and align performance metrics and quality standards in project management operations.
Work closely with the Regional Operations Support Lead (ROSL) to understand capacity needs and integrate them into country allocation discussions.
Provide guidance to project management teams on developing and implementing regional processes and tools.
Issue Escalation & Trend Analysis:
Lead regional issue escalation and conduct trend analysis to identify operational challenges across studies and therapeutic areas.
Facilitate resolution and action plans in coordination with HQ, CRDs, and delegates, serving as a sentinel for operational risks.
Foster cultural diversity awareness and address cross-country business needs in regional interactions.
Strategic Leadership & Collaboration:
Contribute to defining and executing regional priorities to ensure successful delivery across countries.
Provide deep insights into operational strategy, functional areas, and networks that enable effective execution.
Share best practices, seek improvement opportunities, and drive alignment across GCTO.
Line Management:
Lead and manage the regional team, including the Regional Operations Lead (ROL), Regional Operations Support Lead (ROSL), and Regional Operations Analyst (ROA).
Education:
Required:
Bachelor’s degree in life science discipline.
Preferred:
Advanced graduate degree (e.g., Master’s in life sciences, or PhD, PharmD); Business and Financial Management (e.g., MBA) advantage.
AI Certification
Required Experience and Skills:
Clinical Operations Experience: Minimum 10 years of experience in clinical operations, preferably within a Sponsor environment, managing studies in different therapeutic areas, phases, from study initiation through completion. Understanding of inspection readiness.
Leadership: Strong leadership skills to align teams with the goals and mission of our Research & Development Division Global Clinical Development (GCD), and GCTO. Demonstrated success in building and maintaining networks. Ability to communicate effectively with stakeholders, to work independently as well as strong business and financial acumen. Willingness to take accountability for actions and to drive results within region.
Regulatory Knowledge: Comprehensive understanding of ICH GCP guidelines and global, regional, and local regulatory requirements.
Communication Skills: Excellent written and verbal communication skills in English, with the ability to communicate effectively and professionally at all levels. Additional Language Skills: Proficiency in local languages is advantageous but not mandatory.
clinicaltrialjobs
EligibleforERP
Required Skills:
Business Acumen, Change Leadership, Clinical Operations, Data Analytics, Digital Fluency, Innovation, New Technology Integration, Personnel Resource Management, Strategic Thinking
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
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.
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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
10/20/2026
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.
