Executive Director Clinical Research France H/F - Inventing for Life

Job DescriptionThe 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 requirementStrategic country / cluster representative for initiatives at all levels of the organizationBuild 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 objectivesLeads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division / GCD Therapy Areas, and when appropriate Human HealthWorking 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 talentProactively manages and develops talentProactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitmentCreates an empowering, compliant, collaborative, and innovation-focused work environmentBuilds a culture of quality and compliance through training, oversight, and collaborationOversight to ensure appropriate scientific and operational training for staff membersClinical 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 expectationsDevelopment and delivery of company standards in given geographyActivities of all cluster/country level GCTO team & all programs and studiesApproved administrative budget to support GCTO team (e.g., salaries & travel)Country level operational study budgetsRegulatory 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 AffairsResponsible and supports development of audit responses and completion of CAPAsCollaborates and supports:Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolioClinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the successful conduct of outsourced clinical trialsEngagement With Key External StakeholdersSupporting Management and the clinical operations of studies managed by GCTOSupport the development and management of Investigator and operational relationships in conjunction with all our Research & Development Division Therapy Areas, and when appropriate Human Health colleaguesContribute to the program life-cycle management through effective study allocation and execution (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 the countrySets clear performance standards and holds self and organization accountable for achieving results. 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 objectivesTake responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and 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 and collaborate with different stakeholders within GCTO and our Research & Development Division in a matrix organizationManagement expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project deliveryA complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is requiredStrong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communicationStrategic thinkingEagerness to help the department adapt to digital transformationBehavioural Competency Expectations:High emotional intelligenceStrong 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 GCTOPositive 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 DescriptionsPreferred Skills: Current Employees apply Current Contingent Workers apply Search Firm Representatives Please Read CarefullyMerck & 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):Job Posting End Date:08/23/2026*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.