Executive Director, Global Clinical Programs

Merck; New Jersey; In loco; USD 200.000 - 320.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an experienced leader to oversee strategic and operational aspects of complex clinical programs across disease areas, from planning through post-approval. You will direct global cross-functional teams, shape development plans, and ensure delivery of program objectives with governance.

In this role you will manage trial schedules, oversee enrollment planning, resource staffing, risk management, and collaboration with stakeholders including KOLs and vendors.

Mansioni

• Leading and directing teams within a program/disease area/asset on key program planning and execution elements (e.g., program-level overviews; senior management and governance meetings)
• Providing operational input at the CST level during protocol design (e.g., feasibility, execution risk, operational implications of design choices) and on program-level development planning documents (e.g., Clinical Development Plan, Protocol Concept Sheet, Protocol), ensuring program-level consistency and delivery of program objectives
• Developing and maintaining the Clinical Operations Project Schedule, defining timelines for key trial milestones (e.g., DBL), and providing ongoing operational oversight of trial plan deliverables (e.g., Central Lab plan, Specimen Management Plan)
• Providing program-, disease-area, or asset-level oversight & context to inform trial-level enrollment, site feasibility & selection, and leading patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders across trials
• Conducting resource planning and staffing across a program, disease area, or asset (hiring and/or project onboarding; management of Trial Managers; may include management of other Program Leads)
• Holding overarching responsibility and oversight of program, disease-area, or asset-level execution, providing innovative ideas to achieve organizational objectives, tracking key trial milestones and metrics across the program, proactively managing delays, and surfacing execution risks
• Leading efforts and applying expertise to maximize operational feasibility and efficiency, and ensuring consistency and quality across the assigned portfolio
• Serving as the primary escalation point for trial teams on operational issues, fielding and resolving cross-functional issues, promoting cross-functional solutions, and escalating to management as needed
• Partnering with Portfolio Sourcing & Relationship Management (PSRM) on program-level service provider strategy (e.g., selection, qualification, contracting, oversight), resolving escalated issues and promoting consistent standards across studies
• Reviewing and providing expert operational input on trial-level regulatory submissions (e.g., IND, CTA, Article 46), Health Authority responses and meeting material, Risk Language, and the Clinical Study Report
• Reviewing trial-level ADI/RAID logs, Quality Plans, and readouts from quality metric dashboards (e.g., protocol deviations, temperature excursions), and proactively identifying and minimizing operational risks across the program/disease area/asset (e.g., clinical supply disruptions, service provider performance issues), escalating issues to CST and PDT as needed
• Collaborating with CQRM, CQOM, and CST to develop, maintain, and review the program-level RACT (including program-specific metrics and thresholds, e.g., KRIs, QTLs), and reviewing and approving the Program Quality Plan
• Reviewing protocol-level CTQ factors and key trial plans to ensure program-/disease-area/asset-level consistency as appropriate and quality control (e.g., reduction of manual data tracking/review efforts, appropriate balance between site & central monitoring)
• Owning proactive inspection readiness across the trial/program lifecycle, including supporting the authoring of post-inspection observation responses and CAPA/SQI management, in close collaboration with Clinical Quality Operations
• Serving as the operational representative on the Product Development's Clinical Subteam to elevate trial-/program-/disease-area-/asset-level risks, quality issues, and timeline/cost challenges, integrating solutions into program-level planning
• Collaborating and facilitating interactions with key internal and external stakeholders (e.g., KOLs, vendors) in support of clinical program/disease-area/asset objectives
• Leading and implementing process improvement and strategic initiatives (e.g., digital transformation)
• Potentially leading operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations)
• Training, upskilling, and supervising direct and indirect reports, and managing the professional development and performance of direct reports, which may include Trial Managers and other Program Leaders
• Supporting CTT onboarding a

Descrizione del lavoro

Merck is seeking an experienced leader to oversee strategic and operational aspects of complex clinical programs across disease areas, from planning through post-approval. You will direct global cross-functional teams, shape development plans, and ensure delivery of program objectives with governance.

In this role you will manage trial schedules, oversee enrollment planning, resource staffing, risk management, and collaboration with stakeholders including KOLs and vendors.