Job Description
Global Clinical Trial Operations (GCTO) is a global organization with over 9500 people operating in 47 countries. The Clinical Sciences and Study Management organization (CSSM) is a sub-functional unit within GCTO, divided into three therapeutic clusters, with over 1000 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget more than $1B.
Key activities for this role include the strategic planning, oversight, management and execution of HQ-sponsored trials for the assigned Therapeutic Area Section, including local registration trials and regulatory commitments. The position is also directly responsible for the technical/ scientific support of all clinical research trials and programs within the defined Therapeutic Area Section. Applies an in-depth understanding of our Research and Development Division's clinical development strategy in the implementation of short and long-term research objectives.
Liaises with cross functional areas supporting clinical development including Global Clinical Development Therapeutic Area/ Section Heads and Senior Regulatory and Safety Executives to ensure staffing and support is consistent with development priorities.
Responsible for ensuring that members of the staff are provided with appropriate vision, direction, training, and sponsorship of projects and initiatives. Ensures performance management and career development plans are implemented by direct supervisors and that the entire organization is compliant with all policies and procedures. This role is a highly cross functional and influential role with GCD.
Primary Responsibilities:
Provide leadership to the designated Area within CSSM. This includes continual optimization of the organizational resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Identify and drive enhancements/standardization of CSSM TA deliverables and tolls/processes to increase efficiencies. Provide leadership during conduct of risk assessments and mitigation planning for priority program execution. Engagement with key vendor partners to align on strategy, execution, and delivery for the expanding portfolio.
Ensure the successful execution for all headquarter based patient clinical trials. Provides direction and oversight to teams in preparation for Late-Stage Development Review Committee, Operational Reviews, and Deep Dive Meetings. As CSSM has accountability for the overall success of the studies, this is achieved by defining the overall Indication, program and study clinical operational strategies, ensuring rigorous leadership across all levels of the organization, overall study budget management and comprehensive program and study communication with all internal and external stakeholders. Ensure implementation of job related tools and systems by staff. Ensure implementation of job-related tools and systems by staff. In addition, ensure the development of detailed study design specifications, medical monitoring of study data and summarizing results for assigned Research and Development clinical trials.
Represent GCTO and CSSM on strategic initiatives at all levels of the organization. Provide leadership to the CSSM organization as a member of the CSSM Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staffs are assigned to effectively execute on the Book of Business and achieve GCD and Research and Development objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Division/ Area R&D - Clinical Operations
Education:
Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.
Required Experience and Skills:
15+ years of relevant experience working on clinical development programs (pharma/biotech/academia/government) or equivalent combination of education and experience required.
Extensive experience in the planning and execution of clinical trials with demonstrated ability to translate knowledge and expertise to areas at all levels within the R&D sphere of influence (Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, Functional Service Providers, and Vendors etc.). Demonstrated ability to effectively manage scope, time and cost of assigned projects; is business savvy and results oriented.
Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives. Functional Area Clinical Research Job Family Clinical Operations Management or Individual Contributor Management Geographical Scope Global Additional (Budget/headcount)
Preferred Experience and Skills:
clinicaltrialjobs
EligibleforERP
Required Skills:
Budget Management, Clinical Data Management, Clinical Data Standards, Clinical Operations, Clinical Studies, Clinical Trials Operations, Executive Leadership, Matrix Leadership, Oncology, People Leadership, Project Management, Regional Operations, Regulatory Governance, Strategic Leadership, Strategic Management, Strategic Planning
Preferred Skills:
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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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 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
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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/International
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/22/2026
*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.