Global Head, Program & Study Management

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 256,000 - 403,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co. is seeking a senior leader for Global Clinical Trial Operations, responsible for strategic planning and end-to-end management of HQ-sponsored trials.

You will partner with Clinical leadership to align operational capabilities with development priorities and ensure staffing, sponsorship, and performance management across a global team. The role emphasizes AI-enabled modernization, risk mitigation, and adherence to GCP/ICH standards, with a focus on delivering high-quality clinical

Qualifications

• 12+ years of relevant experience working on clinical development programs (pharma/biotech/CRO) or equivalent combination of education and experience required.
• Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives.
• Expertise in the designated TA with understanding of the specific operational challenges of the TA.
• Digital & AI Leadership: Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations.
• Regulatory & Quality Rigor: strong knowledge of GCP/ICH and global regulatory expectations.
• Proven history of developing talent and building robust talent pipelines.
• Matrix Influence: Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams.

Responsibilities

• Translate TA objectives into robust, executable operational strategies for all clinical programs and studies.
• End-to-End Program and Study Delivery: Full accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with high quality.
• Ensure proactive cross-functional collaborations to develop robust trial delivery strategies and assess trial delivery risk monthly.
• Drive KPI and KQI driven performance measurement and continuous improvement across domains.
• Leverage predictive analytics and AI-driven insights to identify, monitor, and mitigate operational risks.
• Provide escalation point for resolving complex operational issues across functional leaders.
• Ensure compliance with GCP, ICH and global regulatory requirements.
• Lead readiness for GCD late-stage reviews, operational reviews, inspections and audits.

Skills

Artificial Intelligence (AI)

Clinical Development

Clinical Trial Planning

Clinical Trials

Digital Leadership

Executive Leadership

Global Team Collaboration

Good Clinical Practice (GCP)

ICH GCP Guidelines

Key Performance Indicators

Matrix Leadership

Ophthalmology

Regulatory Requirements

Strategic Leadership

Education

Bachelor's degree in scientific field

Advanced scientific degree (MS, PharmD, Ph.D.) preferred

Job description

Merck & Co. is seeking a senior leader for Global Clinical Trial Operations, responsible for strategic planning and end-to-end management of HQ-sponsored trials.

You will partner with Clinical leadership to align operational capabilities with development priorities and ensure staffing, sponsorship, and performance management across a global team. The role emphasizes AI-enabled modernization, risk mitigation, and adherence to GCP/ICH standards, with a focus on delivering high-quality clinical