Job Description
The Regional Head manages all aspects of clinical trial operations in the region and reports to the Global Head of Global Clinical Trial Operations (GCTO) Regions. This position is responsible for exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and Clinical Research Organization (CRO) run studies. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies is essential.
The position is responsible for trial quality and audit responses and completion of Corrective and Preventive Action (CAPAs). The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the region, sub-region/clusters and individual countries. The position has multiple touch points with GCTO and Research and Development (R&D) staff in the US headquarters, or in the Global Clinical Development (GCD) regional office. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Global Human Health (GHH)/Value and Implementation (V&I). The Regional Head represents the GCTO organization both internally and externally within the industry.
Primary Responsibilities:
Provide Leadership to the Region. This includes continual optimization of the organizationaldesign and resources, ownership and optimization of key processes, talent and successionmanagement, overall operating budget management and oversight of all high priority programsand studies. Adhere to our company's standards and R&D/ GCD and GCTO goals, initiatives andexpectations. Participate and support the goals and objectives of the GCTO Senior LeadershipTeam (SLT) or extended Leadership Team (eLT). Speak with "one voice" on agreed strategies.
Manage Clinical Operations activities and personnel within the Region, Regional Country andCluster Directors, and their respective staff. Ensure that compliance, quality and timelineobjectives are met for all trials executed in the region.
Work collaboratively in a matrix organization with all groups within GCTO, especially with ClinicalSciences and Study Management (CSSM) and regional Quality Managers, to deliver objectives.
Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate andappropriate resourcing for our company's internal clinical trial portfolio
Collaborate with Clinical Research Organization (CRO) Senior Leadership to ensure thesuccessful implementation of fully-outsourced clinical trials as needed.
Work with the Global Trial Optimization group within GCTO and Global Medical Directorsas appropriate, in site management and selection decisions. Provide input into protocoldesign, feasibility, and resource assessments as appropriate.
Support the development and management of Investigator relationships in conjunction with theR&D Therapy Areas, Global Clinical Development and when appropriate, Human Healthcolleagues. Contribute to the program life-cycle management through effective study allocation
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).
Represent GCTO and the Regions on strategic initiatives at all levels of the organization.
Provide leadership to the GCTO organization as a member of the extended GCTO SeniorLeadership Team. Effectively manage resources to ensure appropriately skilled and highperforming staff members are assigned to support the effective execution of the portfolio andachieve GCTO, GCD, and R&D objectives. Set clear performance standards and holds self andorganization accountable for achieving results. Embrace GCTO metrics and performancestandards (KPI's)
Responsible for ensuring appropriate scientific and operational training for staff members.
Education:
Required: Master's Degree in a life science combined with a proven track record of contribution to and delivery of clinical trials. Business and financial management skills are an added advantage (e.g. MBA)
Preferred: An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS)
Required Experience and Skills:
10-15 years of experience in clinical operations, preferably in Sponsor environment workingon multi-phase, multi-therapeutic and diverse clinical trials from study initiation tocompletion and associated regulatory submission and inspection preparation
Strong Leadership skills that will attract, motivate, inspire, develop and retain talented staff.In addition, Leadership skills that enable and drive alignment with the goals, purpose andmission of our Research and Development Division, Global Clinical Development (GCD) and GCTOSignificant Management experience in a Clinical Trials setting, with the ability to service andcollaborate with different stakeholders within GCTO and R&D 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 requirementsis required.
Strong Communication skills requiring proficiency in written and spoken English. Theincumbent must be competent and effective in written and verbal communication.
Proficiency in local languages is an added advantage, but not a pre-requisite
Current Employees apply HERE
Current Contingent Workers apply HERE
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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
$304,800.00 - $479,800.00This 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Budget Management, Budget Management, Building Leadership Teams, Business, Change Management, Clinical Operations, Clinical Risk Management, Clinical Site Management, Clinical Supplies Management, Clinical Testing, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Methodology, Clinical Trials Logistics, Clinical Trials Monitoring, Clinical Trials Operations, Communication, Confidentiality, Cross-Cultural Awareness, Ethical Standards, Good Clinical Practice (GCP), High Performance Team Building, Innovation, Management Process, Motivation Management {+ 4 more}Preferred Skills:
Job Posting End Date:
07/12/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R353656