Senior Director, Program Lead - Neuroscience

MSD•Rahway, NJ

About The Position

The Senior Director, Program Lead provides expert strategic and operational leadership for highly complex clinical development programs, potentially spanning multiple disease areas or indications and involving 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 dynamic biopharmaceutical environment. The position has direct and indirect reports and manages teams across programs or within a disease area. The role oversees program-, disease-area-, or asset-level planning and execution, including operational input into protocol design and development plans; clinical operations schedules, trial milestones, and deliverables; resource planning and staffing; enrollment, site feasibility, and patient and site engagement; service-provider strategy; and management of operational risks, quality, timelines, and costs. It serves as an escalation point for trial teams and as the operational representative on the Product Development Clinical Subteam. The position partners with clinical quality and other cross-functional colleagues on risk and quality plans, inspection readiness, regulatory submissions, and study documentation. It also leads process-improvement and digital-transformation initiatives, promotes AI fluency in clinical operations, may lead operational aspects of mergers and acquisitions, and develops and supervises direct and indirect reports. The role is in Clinical Development, reports to a role listed as TBD, and is primarily located in Rahway, New Jersey. The posting describes the work arrangement as not applicable to flexible work arrangements and lists a first-shift day schedule.

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 and technology support, resourcing, and implementation in line with budgets or project plans.
Ability to collaborate and navigate high-stakes conflicts with internal and external stakeholders, using expertise and strategic influence.
Advanced problem-solving, critical-thinking, and scenario-planning skills, including resolving complex technical, operational, and financial problems while balancing resources against department objectives.
Advanced verbal and written communication skills.
Strong leadership, 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.

Nice To Haves

A 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 key trial milestones, and provide operational oversight of 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 across trials.
Conduct resource planning and staffing across programs, disease areas, or assets, including hiring or onboarding and managing Trial Managers and potentially other Program Leads.
Oversee program-, disease-area-, or asset-level execution, track trial milestones and metrics, proactively manage delays, surface execution risks, and develop ideas to achieve organizational objectives.
Maximize operational feasibility and efficiency and promote consistency and quality across the assigned portfolio.
Serve as the primary escalation point for trial-team operational issues, resolve cross-functional issues, promote solutions, and escalate issues 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 program-level operational risks and escalate issues as needed.
Collaborate with CQRM, CQOM, and CST to develop, maintain, and review program-level RACTs, including program-specific metrics and thresholds, and review and approve Program Quality Plans.
Review protocol-level CTQ factors and key trial plans to ensure appropriate program-level consistency and quality control.
Own proactive inspection readiness throughout 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 integrate solutions for trial- and program-level risks, quality issues, and timeline or cost challenges into program 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, including digital transformation, and potentially lead operational components of mergers and acquisitions.
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 to improve efficiency and data-driven decision-making in clinical operations.