Senior Director, Program Lead - Cardiovascular

MSD • Rahway, NJ

5d • $210,400 - $331,100 • Onsite

About The Position

This role provides expert strategic and operational leadership in planning and executing highly complex clinical programs, such as programs spanning multiple disease areas or indications and involving large outcome trials. The position 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 in a fast-paced biopharmaceutical company. 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 and trial milestones; enrollment, site feasibility, and patient and site engagement strategies; resource planning and staffing; operational risks, quality, regulatory submissions, inspection readiness, and service-provider strategy. The role represents operations on the Product Development Clinical Subteam, collaborates with internal and external stakeholders, and leads process improvement and strategic initiatives, including digital transformation and AI fluency initiatives. It may also lead operational aspects of mergers and acquisitions. The role trains, coaches, supervises, and supports the professional development of direct and indirect reports.

Candidates must meet one of the listed education-and-experience combinations: a bachelor’s degree and 15 years, a master’s degree and 12 years, or a PhD/PharmD and 8 years of pharmaceutical and/or clinical drug development experience. The position is based primarily in Rahway, New Jersey, with 10% travel, a first-shift schedule, and no relocation. Flexible work arrangements are listed as not applicable.

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, and technology support, resourcing, and implementation according to budgets or project plans.
• Ability to collaborate and navigate high-stakes conflicts with internal and external stakeholders, leading 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 with department objectives and maintaining an enterprise view.
• 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, master’s degree plus 12 years, or PhD/PharmD plus 8 years of pharmaceutical and/or clinical drug development experience.
• Required skills include Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Ethical Standards, Exercises Judgment, Global Clinical Studies, Patient Safety, Regulatory Submissions, Scientific Writing, and Therapeutic Knowledge.

Nice To Haves

• A degree in life sciences is preferred.
• Project Management Professional (PMP) certification is preferred.
• 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-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-, disease-area-, or asset-level context for enrollment, site feasibility, and site selection, and lead patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders.
• Plan resources and staffing across a program, disease area, or asset, including hiring or onboarding and management of Trial Managers and potentially other Program Leads.
• Oversee program-, disease-area-, or asset-level execution; track trial milestones and metrics; proactively manage delays and surface 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 cross-functional 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 and provide expert 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-metric dashboard readouts; identify and minimize operational risks across the program, disease area, or asset; 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 in collaboration 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 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, and supervise direct and indirect reports; manage direct reports’ professional development and performance.
• Support CTT onboarding and develop Trial Manager role-specific training.
• Champion initiatives for 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.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

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