Executive Director, Clinical Research France

Job description

Job Description The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster.Main responsibilities :The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:- Supports the regional GCTO leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement- Strategic country / cluster representative for initiatives at all levels of the organization- Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and our Research & Development Division objectives- Leads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division / GCD Therapy Areas, and when appropriate Human Health- Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associationsLeadership and Management of the GCTO country / cluster Organization:- Recruits and hires talent- Proactively manages and develops talent- Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment- Creates an empowering, compliant, collaborative, and innovation-focused work environment- Builds a culture of quality and compliance through training, oversight, and collaboration- Oversight to ensure appropriate scientific and operational training for staff members.Clinical Operation Management:Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.Leadership and oversight of the following:- Research & Development Division / GCD / GCTO goals, initiatives and expectations- Development and delivery of company standards in given geography- Activities of all cluster/country level GCTO team & all programs and studies- Approved administrative budget to support GCTO team (e.g., salaries & travel)- Country level operational study budgets- Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs- Responsible and supports development of audit responses and completion of CAPAs.Collaborates and supports:• Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate andappropriate resourcing for company internal clinical trial portfolio• Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure thesuccessful conduct of outsourced clinical trialsEngagement With Key External Stakeholders- Supporting Management and the clinical operations of studies managed by GCTO- Support the development and management of Investigator and operational relationships inconjunction with all our Research & Development Division Therapy Areas, and when appropriate Human Health colleagues- Contribute to the program life-cycle management through effective study allocation andexecution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).Quality / Compliance Adherence / Standard:- Ensure that compliance, quality and timeline objectives are met for all trials executed in thecountry.- Sets clear performance standards and holds self and organization accountable for achievingresults. Embraces GCTO metrics and performance standards (KPI’s)- Work collaboratively in a matrix organization with all groups within GCTO, especially with ClinicalSciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and RegionalOperations Teams, to deliver objectives- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) groupand the Good Clinical Practice Quality and Compliance Council (GCP QCC).Requirements and expectations :CORE Competency Expectations:• Significant Management experience in a Clinical Trials setting with the ability to service andcollaborate with different stakeholders within GCTO and our Research & Development Division 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 isrequired.• Strong Communication skills requiring proficiency in written and spoken English and preferablylocal language. The incumbent must be competent and effective in written and verbalcommunication.• Strategic thinking• Eagerness to help the department adapt to digital transformationBehavioural Competency Expectations:• High emotional intelligence• Strong leadership 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 & Development Division, Global Clinical Development (GCD) and GCTO• Positive proven success in people managementEducational Requirements:Required:• Bachelor’s degree in Science or equivalent healthcare experiencePreferred:Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) Required Skills: Adaptability, Budget Management, Clinical Medicine, Clinical Research, Clinical Research Coordination, Clinical Research Organizations (CRO) Management, Clinical Sciences, Clinical Staffing, Clinical Trial Compliance, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Ethical Standards, Grant Writing, ICH GCP Guidelines, Job Descriptions, Medical Research, Mentorship, People Leadership, Resource Allocation, Results-Oriented, Risk Management, Strategic Thinking, Writing Job Descriptions Preferred Skills: 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: 08/23/2026*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.