Senior Director, Program Lead - Neuroscience

MSD•Rahway, NJ

5d•$210,400 - $331,100•Onsite

About The Position

This position provides expert strategic and operational leadership in the planning and execution of 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 activities, from strategic planning through post-marketing approval, within a fast-paced biopharmaceutical company. The position 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; provides operational input into protocol design and development plans; and maintains clinical operations schedules and oversight of trial deliverables. The role supports enrollment, site feasibility and selection, patient and site engagement, resource planning, staffing, and trial execution. It tracks milestones and metrics, proactively manages delays and operational risks, and promotes feasibility, efficiency, quality, and consistency across the assigned portfolio. The position serves as a primary escalation point for trial teams and partners with internal functions, service providers, and external stakeholders. It reviews regulatory submissions, health authority materials, quality plans, risk records, trial plans, and study reports; supports risk-based quality management and inspection readiness; and contributes to program-level planning through representation on the Product Development Clinical Subteam. The role also leads process improvement and strategic initiatives, potentially supports operational components of mergers and acquisitions, and trains, coaches, supervises, and develops direct and indirect reports. It champions digital proficiency and AI fluency to improve efficiency and data-driven decision-making in clinical operations.

Requirements

Expert knowledge of Good Clinical Practice (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 in accordance with 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 balancing resource availability and 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 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.
Adaptability.
Innovation.
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 trial milestones, 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.
Conduct resource planning 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, proactively 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, resolve cross-functional operational issues, promote solutions, and escalate issues to management as needed.
Partner with Portfolio Sourcing & Relationship Management on service-provider strategy, 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 metric dashboards; identify and minimize operational risks across the program, disease area, or asset and escalate as needed.
Collaborate with CQRM, CQOM, and CST to develop, maintain, and review the program-level RACT, and review and approve the Program Quality Plan.
Review protocol-level CTQ factors and key trial plans for 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 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 Key Opinion Leaders 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 integration.
Train, upskill, supervise, and develop direct and indirect reports; manage direct reports’ professional development and performance.
Support CTT onboarding and develop role-specific training for Trial Managers.
Champion digital proficiency and AI fluency initiatives to enhance efficiency and data-driven decision-making in clinical operations.