Senior Director, Program Lead - Infectious Diseases

MSD • Rahway, NJ

3d • Hybrid

About The Position

The Senior Director, Program Lead provides expert strategic and operational leadership for highly complex clinical development programs, including programs spanning multiple disease areas or indications and large outcome trials. The role leads global, cross-functional teams through end-to-end clinical development, from strategic planning through post-marketing approval, and manages direct and indirect reports across programs or within a disease area.

The position oversees program planning and execution, clinical operations schedules and milestones, resource and staffing plans, operational feasibility, trial quality and risk management, service-provider strategy, regulatory submissions, and inspection readiness. It serves as the operational representative on the Product Development Clinical Subteam and as a primary escalation point for trial teams. The role also supports process improvement and strategic initiatives, including digital transformation and AI-enabled approaches, and may lead operational components of mergers and acquisitions.

The Senior Director trains, coaches, and supervises direct and indirect reports, supports CTT onboarding and Trial Manager training, and drives digital proficiency and AI fluency in clinical operations. The role is based in Rahway, New Jersey, with a hybrid work arrangement and approximately 10% travel. Relocation assistance and visa sponsorship are not offered.

Requirements

• Bachelor’s degree plus 15 years, Master’s degree plus 12 years, or PhD/PharmD plus a minimum of 8 years of pharmaceutical and/or clinical drug development experience.
• Expert knowledge of Good Clinical Practice (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 outputs and understanding their 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 project, program, or technology changes within a budget or project plan.
• Ability to collaborate and navigate high-stakes conflicts with internal and external stakeholders, using expertise and strategic influence.
• Advanced problem-solving, critical-thinking, and scenario-planning skills, including resolving complex technical, operational, and financial problems while balancing resources against department objectives.
• Advanced verbal and written communication skills.
• Strong leadership skills, including influencing stakeholders and building talent through oversight, coaching, and mentoring.

Nice To Haves

• Degree in life sciences.
• Project Management Professional (PMP) certification.
• Experience conducting pragmatic studies.
• Adaptability, innovation, and strategic thinking.

Responsibilities

• Lead and direct teams within a program, disease area, or asset on key planning and execution activities, including program-level overviews and senior management and governance meetings.
• Provide operational input 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 site selection, and lead patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders.
• Conduct resource planning and staffing across programs, disease areas, or assets, including hiring or onboarding and management of Trial Managers and potentially other Program Leads.
• Oversee program- or asset-level execution, track trial milestones and metrics, proactively manage delays, identify execution risks, and develop ideas 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-team operational issues, resolve cross-functional issues, promote solutions, and escalate to management as needed.
• Partner with Portfolio Sourcing & Relationship Management on program-level service-provider strategy, including selection, qualification, contracting, and oversight.
• Review trial-level regulatory submissions, Health Authority responses and meeting materials, Risk Language, and Clinical Study Reports, providing expert operational input.
• Review trial-level ADI/RAID logs, Quality Plans, and quality-dashboard readouts; identify and minimize operational risks and escalate issues as needed.
• Collaborate with CQRM, CQOM, and CST to develop, maintain, and review the program-level RACT and its metrics and thresholds; review and approve the Program Quality Plan.
• Review protocol-level CTQ factors and key trial plans to ensure appropriate program-level consistency and quality control.
• Own proactive inspection readiness across the trial and program lifecycle, including supporting post-inspection responses and CAPA/SQI management with Clinical Quality Operations.
• Represent Clinical Operations on the Product Development Clinical Subteam and escalate trial-, program-, disease-area-, or asset-level risks, quality issues, and timeline or cost challenges, integrating solutions into program planning.
• Collaborate with internal and external stakeholders, including KOLs and vendors, in support of clinical program objectives.
• Lead and implement process-improvement and strategic initiatives, including digital transformation, and potentially lead operational components of mergers and acquisitions.
• Train, upskill, supervise, coach, and mentor direct and indirect reports; manage direct reports’ professional development and performance.
• Support CTT onboarding and develop Trial Manager role-specific training.
• 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 a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

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