Head of Clinical Program & Study Delivery

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck is seeking a senior leader for Global Clinical Trial Operations to guide program and study management across therapeutic areas. The role partners with Clinical leadership to integrate GCTO capabilities into the development pipeline, driving efficiency, quality, and strategic alignment across studies.

Ideal candidates bring extensive pharma/biotech experience, strong regulatory knowledge, and a track record of talent development in a global matrix environment.

Qualifications

• Bachelor's degree in a scientific field is required.
• Advanced degree (MS/PhD/PharmD) or equivalent experience preferred.
• Proven ability to lead large cross-functional clinical programs.

Responsibilities

• 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 monthly delivery risk.
• Drive end-to-end trial delivery through continuous improvement and KPI/KQI driven measurement.
• Leverage predictive analytics and AI-driven insights to monitor and mitigate operational risks.
• Act as escalation point for resolving complex issues across functional leaders and teams.
• Ensure activities comply with GCP, ICH guidelines, and global regulatory requirements.
• Prepare for GCD late-stage reviews, Ops reviews, inspections, and audits.

Skills

AI

Clinical Development

Clinical Trials

GCP

ICH GCP Guidelines

Strategic Leadership

Digital Leadership

Matrix Leadership

Global Team Collaboration

Regulatory Requirements

Education

Bachelor's degree

Advanced scientific degree (MS/PhD/PharmD)

Job description

Merck is seeking a senior leader for Global Clinical Trial Operations to guide program and study management across therapeutic areas. The role partners with Clinical leadership to integrate GCTO capabilities into the development pipeline, driving efficiency, quality, and strategic alignment across studies.

Ideal candidates bring extensive pharma/biotech experience, strong regulatory knowledge, and a track record of talent development in a global matrix environment.