Head, Program and Study Management – Oncology

MSD

Leadership role overseeing clinical trial operations, strategy, and team performance in Oncology. Driving high-quality delivery and fostering collaboration in a global health care leader.

Posted 7/20/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $310,900 - $489,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial operations and drug development, with a strong focus on strategic operational planning, execution, and compliance with GCP/ICH guidelines. Proven ability to leverage digital solutions, including AI and predictive analytics, to enhance clinical operations and drive organizational excellence.

Highest-signal resume keywords

Clinical Trial OperationsRegulatory SubmissionsPredictive AnalyticsGood Clinical Practice (GCP)Talent Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Program ManagementOperational Strategy DevelopmentBudget ManagementResource AllocationDigital Solutions Implementation

Soft Skills

Executive PresenceInfluencing Without AuthorityCross-Functional CollaborationMentorshipContinuous Improvement

Tools & Technologies

AI-Enabled SolutionsAutomation ToolsPredictive Analytics Platforms

Industry Keywords

Pharmaceutical IndustryBiotechnologyCRO IndustryClinical DevelopmentRegulatory Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Contribute to the development and execution of the GCTO vision, strategy, and goals, ensuring alignment with the broader company, Research and Development (R&D) and Global Clinical Development (GCD) strategy
Serve as the GCTO point of accountability for the assigned TA(s), partnering closely with GCTO Functions and GCD TA and CS Heads to provide strategic operational input into the overall clinical development plan
Translate scientific and TA objectives into robust, executable operational strategies for all clinical programs and studies
Guide GCTO teams to understand the competitive landscape, the scientific rationale for development programs, and the long-term vision for assets
Full accountability for the operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with the highest standards of quality
Ensure proactive cross-functional collaborations to develop robust trial delivery strategies
Inspire excellence and drive reliable, high quality delivery by continuous improvement of processes and KPI driven measurement approaches to track progress, identify risks early, and execute mitigations to ensure end-to-end clinical trial delivery
Provide senior oversight for all phases of clinical trial management, ensuring performance against key indicators (KPIs) and key quality indicators (KQIs)
Drive alignment of CtQ factors at program level
Leverage predictive analytics and AI-driven insights to proactively identify, monitor, and mitigate operational risks, ensuring program milestones are met
Act as the primary escalation point for resolving complex operational issues affecting program and study delivery; working across functional leaders to support teams
Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements
Ensure readiness and leadership for GCD late-stage development reviews, GCTO Ops review, inspections and audits
Serve as the key operational partner to Clinical leadership, ensuring GCTO capabilities and strategies are fully integrated to meet the needs of the development pipeline
Proactively builds and sustains strategic internal and external relationships to accelerate PSM priorities
Provide visible, hands-on leadership for a global team of program and study management professionals, fostering a culture of accountability, collaboration, operational excellence, quality and continuous improvement
Champion the modernization of clinical trial operations by identifying and implementing innovative processes, simplification and AI- and Automation-enabled solutions

Requirements

What you’ll need

Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred
Advanced scientific degree (Master’s, PharmD, PhD) in life sciences, medicine, or a related field strongly preferred
Minimum of 12 years of progressive experience in the pharmaceutical, biotechnology, or CRO industry, with a primary focus on clinical trial operations and drug development
Demonstrated track record of single-point accountability for the successful execution of clinical programs, including pivotal registration trials and regulatory submissions
Proven history of building robust talent pipelines, implementing structured mentorship/rotational programs, and cultivating future directors and program leaders
Expertise in the designated TA with understanding of the specific operational challenges of the TA
Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations
Demonstrated success managing organization budgets, optimizing resource allocation, and reducing costs while accelerating cycle times
Strong knowledge of GCP/ICH and global regulatory expectations
Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days