Senior Director, Program Lead - Cardiovascular

MSD•Rahway, NJ

About The Position

The Senior Director, Program Lead provides expert strategic and operational leadership in planning and executing 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 applies project-management and organizational leadership expertise in a fast-paced biopharmaceutical environment. The position has direct and indirect reports and manages teams across programs or within a disease area. The role is responsible for program-level planning and execution, including operational input into protocol design and development plans; oversight of schedules, trial milestones, plans, enrollment, site feasibility, and patient and site engagement; resource planning and staffing; and proactive management of execution risks, quality, timelines, and costs. It serves as an escalation point for trial teams and partners with internal functions, service providers, patient advocacy groups, and key opinion leaders to advance program objectives. The position provides expert operational review of regulatory submissions, health authority materials, quality plans, risk logs, trial plans, and study reports; supports risk-based quality management and inspection readiness; and represents clinical operations on the Product Development Clinical Subteam. It also leads process-improvement and strategic initiatives, potentially including digital transformation and operational components of mergers and acquisitions. The role trains, coaches, and develops direct and indirect reports, and champions digital proficiency and AI fluency in clinical operations.

Requirements

Expert knowledge of GCP and ICH regulations.
Expert understanding of the end-to-end clinical research process, therapeutic area, and competitive landscape.
Ability to drive 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 shape 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 through expertise and strategic influence.
Advanced problem-solving, critical-thinking, and scenario-planning skills, including resolving complex technical, operational, and financial problems while balancing resource availability against department objectives.
Advanced verbal and written communication skills.
Strong leadership skills, including influencing stakeholders and building talent through oversight, coaching, and mentoring.
Bachelor’s degree and 15 years of pharmaceutical and/or clinical drug development experience, or a master’s degree and 12 years, or a PhD/PharmD and 8 years.
Required skills include clinical trials monitoring, cross-functional teamwork, data management, ethical standards, judgment, global clinical studies, patient safety, regulatory submissions, scientific writing, and therapeutic knowledge.

Nice To Haves

Degree in life sciences.
Project Management Professional (PMP) certification.
Preferred skills include adaptability, innovation, and strategic thinking.

Responsibilities

Lead and direct teams within a program, disease area, or asset on program planning and execution, including program overviews and senior management and governance meetings.
Provide operational input at the CST level during protocol design and on program-level development documents, ensuring program consistency and delivery of objectives.
Develop and maintain the Clinical Operations Project Schedule, define key trial milestone timelines, and oversee 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, including hiring or onboarding and management of Trial Managers and potentially other Program Leads.
Oversee program, disease-area, or asset execution; track milestones and metrics, manage delays, identify 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 teams on operational issues, resolve cross-functional issues, promote solutions, and escalate to management as appropriate.
Partner with PSRM on program-level service-provider strategy, including selection, qualification, contracting, and oversight; resolve escalated issues and promote consistent standards.
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 to CST and PDT as needed.
Collaborate with CQRM, CQOM, and CST to develop, maintain, and review 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 clinical operations on the Product Development Clinical Subteam and escalate risks, quality issues, and timeline or cost challenges while integrating solutions into program-level 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, such as digital transformation, and potentially lead operational components of mergers and acquisitions.
Train, upskill, supervise, and support the professional development and performance of direct and indirect 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.