Global Clinical Programs Director

Merck & Co.; Rahway (NJ); In loco; USD 210.000 - 331.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in Rahway, USA, is seeking an experienced Clinical Operations leader to guide multi-disease programs from planning through post-approval, directing global, cross-functional teams.

You will own program schedules, enrollment strategies, risk management, and collaboration with PSRM and QA to ensure timely delivery and compliant submissions. The role requires extensive pharmaceutical development experience and strong leadership.

Competenze

• Bachelor's degree with 15 years in pharma/drug development.

Mansioni

• Lead and direct teams on program planning and governance meetings.
• Provide operational input during protocol design and development planning.
• Develop and maintain Clinical Operations Project Schedule with milestones.
• Oversee enrollment, site feasibility, and engagement strategies with stakeholders.
• Plan resources, staffing, and manage Trial Managers and leads.
• Ensure execution quality, track milestones, and mitigate risks.
• Escalate issues and promote cross-functional collaboration.
• Collaborate with PSRM on strategy and contracting.
• Support regulatory submissions input and quality plans.

Conoscenze

GCP Regulations

ICH Guidelines

Digital Transformation

Cross-functional Leadership

Regulatory Submissions

Project Management

Formazione

Bachelor's degree + 15 years

Master's + 12 years

PhD/PharmD + 8 years

Strumenti

Clinical DB Platforms

Central Monitoring RBQM

Data Review Tools

Descrizione del lavoro

Merck & Co. in Rahway, USA, is seeking an experienced Clinical Operations leader to guide multi-disease programs from planning through post-approval, directing global, cross-functional teams.

You will own program schedules, enrollment strategies, risk management, and collaboration with PSRM and QA to ensure timely delivery and compliant submissions. The role requires extensive pharmaceutical development experience and strong leadership.