Senior Director, Program Lead - Infectious Diseases

Merck • Rahway, NJ

4d • $210,400 - $331,100 • Hybrid

About The Position

This position provides expert strategic and operational leadership in planning and executing highly complex clinical development programs, including programs spanning multiple disease areas or indications and involving large outcome trials. The role leads and directs global, cross-functional teams across end-to-end clinical development, from strategic planning through post-marketing approval, applying project-management and organizational-leadership expertise. The position has direct and indirect reports and manages teams across programs or within a disease area.

The Program Lead oversees program-, disease-area-, or asset-level planning and execution; provides operational input into protocol design and development planning; manages clinical operations schedules, milestones, resources, and risks; and supports enrollment, site feasibility, patient engagement, and service-provider strategy. The role reviews trial and program quality, regulatory, and operational materials; serves as an escalation point for trial teams; and represents operations on the Product Development Clinical Subteam. It also leads inspection readiness, process improvement, digital transformation, and digital/AI proficiency initiatives, while training, supervising, and developing team members. The role may also lead operational components of mergers and acquisitions.

The position is based in Rahway, New Jersey, with a hybrid work arrangement and 10% travel. Relocation is not offered. The role is regular employment and eligible for an annual bonus and long-term incentive, if applicable. The listed salary range for the primary location is $210,400 to $331,100.

Requirements

• Expert knowledge of GCP and ICH regulations.
• Expert understanding of the end-to-end clinical research process, therapeutic area, and competitive landscape.
• Experience driving strategic adoption of scalable digital and AI-enabled approaches, including reviewing AI output and understanding its limitations and constraints.
• Advanced knowledge of clinical database platforms, central monitoring/RBQM platforms, and data-review tools.
• Advanced delegation, project-management, and program-wide decision-making skills to meet business needs and drive changes to project, program, or technology support, resourcing, and implementation according to a budget or project plan.
• Ability to collaborate and navigate high-stakes conflicts with internal and external stakeholders through expertise and strategic influence.
• Advanced problem-solving, critical-thinking, and scenario-planning skills, including resolving complex technical, operational, and financial problems while balancing resources and department objectives.
• Advanced verbal and written communication skills.
• Strong leadership skills, including influencing stakeholders and developing talent through oversight, coaching, and mentoring.
• Bachelor’s degree plus 15 years, or master’s degree plus 12 years, or PhD/PharmD plus a minimum of 8 years of pharmaceutical and/or clinical drug-development experience.
• Required skills listed: AI Enablement, Clinical Databases, Clinical Research, Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Ethical Standards, ICH Guidelines, Operational Leadership, Project Management, Regulatory Submissions, Scientific Writing, and Therapeutic Knowledge.

Nice To Haves

• Degree in life sciences.
• Project Management Professional (PMP) certification.
• Experience conducting pragmatic studies.
• Preferred skills listed: Adaptability, Innovation, and Strategic Thinking.

Responsibilities

• Lead and direct program-, disease-area-, or asset-level teams on planning and execution, including program overviews and senior management and governance meetings.
• Provide operational input at the Clinical Subteam level during protocol design and on program-level development-planning documents, ensuring consistency and delivery of program objectives.
• Develop and maintain the Clinical Operations Project Schedule, define key trial milestones, and oversee operational trial-plan deliverables.
• Provide program-level context for enrollment, site feasibility and selection, and lead patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders.
• Plan resources and staffing across programs, disease areas, or assets; hire or onboard project staff; and manage Trial Managers and potentially other Program Leads.
• Oversee program execution, track milestones and metrics, proactively manage delays, identify execution risks, and develop innovative approaches to achieve organizational objectives.
• Maximize operational feasibility and efficiency and ensure consistency and quality across the assigned portfolio.
• Serve as the primary escalation point for trial teams on operational issues, resolve cross-functional issues, promote solutions, and escalate issues to management when needed.
• Partner with Portfolio Sourcing & Relationship Management on program-level service-provider strategy, selection, qualification, contracting, and oversight.
• Review and provide operational input on trial-level regulatory submissions, Health Authority responses and meeting materials, Risk Language, and Clinical Study Reports.
• Review trial-level ADI/RAID logs, Quality Plans, and quality-dashboard readouts; identify and minimize program-level operational risks and escalate issues as needed.
• Collaborate with CQRM, CQOM, and Clinical Subteams to develop, maintain, and review program-level RACTs and review and approve Program Quality Plans.
• Review protocol-level CTQ factors and key trial plans for appropriate program-level consistency and quality control.
• Own proactive inspection readiness across the trial and program lifecycle, including support for post-inspection observation responses and CAPA/SQI management with Clinical Quality Operations.
• Represent operations on the Product Development Clinical Subteam and integrate solutions to trial-, program-, disease-area-, or asset-level risks, quality issues, and timeline or cost challenges into program planning.
• Collaborate with internal and external stakeholders, including Key Opinion Leaders and vendors, to support clinical program objectives.
• Lead and implement process-improvement and strategic initiatives, including digital transformation.
• Potentially lead operational components of mergers and acquisitions, including due diligence and portfolio integrations.
• Train, upskill, supervise, coach, and mentor direct and indirect reports; manage the professional development and performance of direct reports.
• Support CTT onboarding and develop role-specific training for Trial Managers.
• Champion digital proficiency and AI fluency to improve efficiency and data-driven decision-making in clinical operations.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior