Country Lead Associate Director Clinical Research

Overview

This role combines the accountability of a clinical research manager and certain elements of a GCTO country lead role. Holders of this position are accountable for the performance and compliance for assigned protocols in a country in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. It includes leadership to a country, liaising with local management, participating in local medical governance, and providing oversight for the GCTO team in the country across phases I / II through III / IV, including potential line management of GCTO staff where required. Responsibilities

CRM component (minimum ~50% of time related to projects; defined by need) : Point of Contact (POC) for assigned protocols between Country Operations (CO) and the clinical trial team (CTT) or ROC where applicable. Proactively drives and tracks execution and performance of deliverables, timelines and results to meet country commitments for assigned protocols. Collaborates with local CO roles. Forecasts country resource needs. Manages contracts and budgets as delegated to serve local business needs. Responsible for quality and compliance in assigned protocols in country, in close collaboration with CRAs and local study teams. Reviews Monitoring Visit Reports and escalates performance issues and training needs to the CRA manager and / or vendors and internal management as needed. Collaborates with functional outsourcing vendors, investigators and other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Provides clinical trial education to sites. Acts as country POC for programmatically outsourced trials for assigned protocols. Collaborates with local PV, Regulatory, GMA / GHH to align on key decisions in studies. Plays a significant role in conducting studies and developing the pipeline while maintaining local regulatory and compliance requirements. As a customer-facing role, builds relationships with investigators and external partners and represents the company in country-level customer interactions. Oversees country commitments, compliance and training needs. Demonstrates the ability to lead across multiple dimensions and align with corporate requirements. Works with Country, Regional and HQ Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health; coordinates with regional and broader organization. Builds and maintains relationships with investigators and external partners and represents the company in pharma industry issues when applicable. Country Lead component (% of time defined by need and typically

Collaborates in a matrix organization with GCTO groups (CSSM, CQMs) to deliver objectives. Works with Functional Service Provider (FSP) local leadership to ensure adequate resourcing for the internal clinical trial portfolio. Collaborates with CRO local leadership to ensure successful outsourced trials. Represents GCTO in Medical Governance Council. Supports Investigator relationships with R&D divisions and Human Health colleagues; contributes to program lifecycle management (prioritizing programs, working with KOLs, etc.). Take responsibility for subsidiary clinical audits, in partnership with QA and the GCP QCC. Represents the GCTO organization internally and externally within the industry in the country. Represents GCTO in the local subsidiary management team (possible extended leadership team). If acting as line manager of GCTO staff : ensure scientific and operational training; manage resources to assign appropriately skilled staff to support portfolio execution and achieve GCTO, GCD and R&D objectives; set performance standards and uphold KPI-oriented performance. Competency Expectations

CORE Competencies : Knowledge in Site Management. Strong organizational skills with demonstrated success. Ability to make decisions independently and oversee activities related to clinical research in the country under global policies with CRM / CRD oversight. Strong understanding of local regulatory environment and ability to weigh pros and cons with input from manager. Strong scientific and clinical research knowledge. Strong understanding of clinical trial planning, management and metrics; ability to manage multiple deliverables and protocols simultaneously. Ability to collaborate across GCTO and OUR RESEARCH & DEVELOPMENT DIVISION in a matrix organization. Ability to manage resource allocation, processes, productivity, quality and project delivery. Strong communication skills in written and spoken English and local language. Strategic thinking. Behavioral Competency Expectations : High emotional intelligence. Leadership skills to align with the goals of OUR RESEARCH & DEVELOPMENT DIVISION, GCD and GCTO. Ability to identify problems, conflicts and opportunities early and lead mitigation plans and conflict resolution. Ability to negotiate skillfully in tough situations with internal and external groups; maintain relationships while driving results; be direct yet diplomatic and timely. Ability to build and maintain professional relationships with investigators and external stakeholders; strong communication, educational, diplomatic and empathetic skills. Experience and Education

Experience Requirements : Required : >

10 years of relevant experience. Priority : People management experience; Saudi market experience. Educational Requirements : Required : Bachelor degree in Science (or comparable). Preferred : Advanced degree (e.g., Master, MD, PhD). Application

Current Employees apply

HERE Current Contingent Workers apply

HERE Notes for Applicants :

Search Firm Representatives Please Read Carefully

Merck & Co., Inc. 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 if a candidate is hired via an agency referral where no pre-existing agreement is in place. When agency agreements exist, introductions are position specific. Please, no phone calls or emails. Employee Status :

Regular Relocation : VISA Sponsorship : Travel Requirements : Flexible Work Arrangements :

Not Applicable Shift : Valid Driving License : Hazardous Material(s) : Required Skills :

Adaptability, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Communication, Cross-Cultural Awareness, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Leadership, Management Process, Oncology Trials, People Leadership, Production Operations, Product Operations Preferred Skills : Job Posting End Date :

10 / 13 / 2025 Note :

A job posting is effective until the day before the listed end date. Please ensure you apply no later than the day before the end date. Requisition ID :

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