Job Description
Associate Vice President, Head of Region Clinical Trials, EEA
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 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 staff in the US Research 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 activities/responsibilities:
- Provide Leadership to the Region. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Adhere to Company standards and the respective goals, initiatives and expectations of our research, clinical development and clinical trials operations organisations. Participate and support the goals and objectives of the GCTO Senior Leadership Team (SLT) or extended Leadership Team (eLT). Speak with “one voice” on agreed strategies.
- Manage Clinical Operations activities and personnel within the Region, Regional Country and Cluster Directors, and their respective staff. Ensure that compliance, quality and timeline objectives are met for all trials executed in the region.
- Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM) and regional Quality Managers, to deliver objectives.
- Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate and appropriate resourcing for the Company’s internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) Senior Leadership to ensure the successful implementation of fully-outsourced clinical trials as needed.
- Work with the Global Trial Optimization group within GCTO and Global Medical Directors as appropriate, in site management and selection decisions. Provide input into protocol design, feasibility, and resource assessments as appropriate.
- Support the development and management of Investigator relationships in conjunction with the research organisation’s Therapy Areas, Global Clinical Development and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
- 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 Senior Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and R&D objectives. Set clear performance standards and holds self and organization accountable for achieving results. Embrace GCTO metrics and performance standards (KPI’s)
- Responsible for ensuring appropriate scientific and operational training for staff members.
Reports to
Global Head GCTO Regions
Extent of Travel
Up to 50%
Qualifications, Skills
& Experience
- An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS,) is preferred or, at minimum, a 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)
- 10-15 years of experience in clinical operations, preferably in Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion 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 and mission of our Research organisation, Global Clinical Development (GCD) and GCTO
- Significant Management experience in a Clinical Trials setting, with the ability to service and collaborate with different stakeholders within GCTO and the Research organisation 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. The incumbent 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
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:
02/24/2025
*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.
