Senior Director, Program Lead - Infectious Diseases

MSD • Rahway, NJ

4d • $210,400 - $331,100 • Hybrid

About The Position

Provides expert strategic and operational leadership in planning and executing highly complex infectious disease programs, including programs spanning multiple disease areas or indications and involving large outcome trials. Leads and directs global, cross-functional teams through end-to-end clinical development, from strategic planning through post-marketing approval, applying project management and organizational leadership expertise in a dynamic biopharmaceutical environment. The role 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; operational input into protocol design and development plans; clinical operations schedules, milestones, resourcing, enrollment, site feasibility, and engagement strategies. The role provides oversight of quality, risk, regulatory submissions, service providers, inspection readiness, and consistency across trials. It serves as an operational representative on the Product Development Clinical Subteam and as an escalation point for trial teams, while collaborating with internal and external stakeholders.

The position also leads process improvement and strategic initiatives, including digital transformation and AI proficiency, may support operational components of mergers and acquisitions, and trains, supervises, coaches, and develops direct and indirect reports. The role is hybrid, based primarily in Rahway, New Jersey, with 10% travel. Relocation is not offered.

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 related to project, program, and 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, using deep expertise and strategic influence.
• Advanced problem-solving, critical-thinking, and scenario-planning skills, including resolving complex technical, operational, and financial problems while weighing resources against department objectives and maintaining an enterprise-wide perspective.
• Advanced verbal and written communication skills.
• Strong leadership skills, including influencing stakeholders and building talent through oversight, coaching, and mentoring.
• Bachelor’s degree plus 15 years of pharmaceutical and/or clinical drug development experience; or a master’s degree plus 12 years; or a PhD/PharmD plus a minimum of 8 years.
• 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

• A 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 teams within a program, disease area, or asset on program planning and execution, including program-level overviews and senior management and governance meetings.
• Provide operational input at the CST 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 timelines for key trial milestones, and oversee trial-plan deliverables.
• Provide program-level context for enrollment, site feasibility and selection, and patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders across trials.
• Plan resources and staffing across programs, disease areas, or assets, including hiring or onboarding and management of Trial Managers and potentially other Program Leads.
• Oversee program-, disease-area-, or asset-level execution; track milestones and metrics, manage delays, and surface execution risks.
• 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 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 metric dashboard readouts, identify and minimize operational risks, and escalate issues as needed.
• Collaborate with CQRM, CQOM, and CST on the program-level RACT, including program-specific metrics and thresholds, and review and approve the Program Quality Plan.
• Review protocol-level CTQ factors and key trial plans for 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, escalating risks, quality issues, and timeline or cost challenges and integrating solutions into program-level planning.
• Collaborate with and facilitate interactions among internal and external stakeholders, including KOLs and vendors, in support of clinical program objectives.
• Lead and implement process improvement and strategic initiatives, such as 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 professional development and performance of direct reports.
• Support CTT onboarding and develop Trial Manager role-specific training.
• Champion digital proficiency and AI fluency initiatives to improve efficiency and data-driven decision-making in clinical operations.

Benefits

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

What This Job Offers

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