Senior Director, Program Lead - Cardiovascular

Merck • Rahway, NJ

4d • $210,400 - $331,100

About The Position

This position 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 role leads and directs global, cross-functional teams through end-to-end clinical development, from strategic planning through post-marketing approval. It applies project management and organizational leadership expertise in a dynamic bio-pharmaceutical environment and includes direct and indirect reports across programs or within a disease area.

The Senior Director provides program-, disease-area-, or asset-level oversight of clinical operations, including program planning, trial execution, operational feasibility, resourcing, quality, risk management, regulatory submissions, inspection readiness, and service-provider strategy. The role represents clinical operations on the Product Development Clinical Subteam, collaborates with internal and external stakeholders, and leads process improvement and digital and AI proficiency initiatives. It also supervises, coaches, and develops direct and indirect reports, which may include Trial Managers and other Program Leaders.

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 affecting 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, 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 and department objectives.
• Advanced verbal and written communication skills.
• Strong leadership skills, including influencing internal and external 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 8 years.

Nice To Haves

• Degree in life sciences.
• Project Management Professional (PMP) certification.
• Preferred skills: 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 program-level consistency and delivery of objectives.
• Develop and maintain the Clinical Operations Project Schedule, define timelines for key trial milestones, and oversee trial-plan deliverables.
• Provide program-level oversight and context for enrollment, site feasibility and selection, and patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders.
• Conduct resource planning and staffing across a program, disease area, or asset, including hiring or project onboarding and management of Trial Managers and potentially other Program Leads.
• Oversee program-, disease-area-, or asset-level execution; track milestones and metrics; proactively manage delays; surface 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 matters to management as needed.
• Partner with Portfolio Sourcing & Relationship Management on program-level service-provider strategy, including selection, qualification, contracting, and oversight; resolve escalated issues and promote consistent standards across studies.
• 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-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 to develop, maintain, and review program-level RACT and 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 support for post-inspection observation responses and CAPA/SQI management in collaboration with Clinical Quality Operations.
• Represent clinical 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, including 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 the professional development and performance of direct reports, which may include Trial Managers and other Program Leaders.
• Support CTT onboarding and develop role-specific training for Trial Managers.
• Champion and drive digital proficiency and AI fluency initiatives 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.
• Compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

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