Senior Director, Program Lead - Neuroscience

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 development programs, including programs spanning multiple disease areas or indications and involving large outcome trials. The role leads and directs global, cross-functional teams across 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 company. The role has direct and indirect reports and manages teams across programs or within a disease area.

The Program Lead provides program-, disease-area-, or asset-level oversight of planning and execution, including operational input into protocol design and development plans, trial schedules and deliverables, enrollment and site strategies, resource planning, risk management, 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 digital transformation initiatives, including adoption of digital and AI-enabled approaches. It also trains, coaches, supervises, and supports the professional development of team members.

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 shape project or program 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 against department objectives.
• Advanced verbal and written communication skills.
• Strong leadership skills, including influencing stakeholders and building talent through oversight, coaching, and mentoring.
• One of the following education and experience combinations: bachelor's degree and 15 years of pharmaceutical and/or clinical drug development experience; master's degree and 12 years; or PhD/PharmD and 8 years.

Nice To Haves

• Degree in life sciences.
• Project Management Professional (PMP) certification.
• Adaptability.
• Innovation.
• Strategic thinking.

Responsibilities

• Lead and direct program or disease-area teams in key planning and execution activities, including program 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 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 a program, disease area, or asset, including hiring or onboarding and management of Trial Managers and potentially other Program Leads.
• Oversee program execution, track trial milestones and metrics, proactively manage delays, surface execution risks, and develop innovative approaches 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 needed.
• Partner with Portfolio Sourcing & Relationship Management on program-level service-provider strategy, including selection, qualification, contracting, and oversight.
• 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 and escalate issues 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 to promote 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 and escalate risks, quality issues, and timeline or cost challenges, integrating solutions into program-level planning.
• Collaborate with internal and external stakeholders, including Key Opinion Leaders 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, 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 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 and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

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