Senior Director, Global Clinical Programs

Merck & Co.; Upper Gwynedd Township (Montgomery County); In loco; USD 210.000 - 331.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in Rahway, NJ, seeks an experienced Clinical Operations leader to direct multi‑program development across disease areas. You will guide global, cross‑functional teams from protocol design to post‑approval, ensuring on‑time delivery and high quality in a fast-paced biotech environment.

Expected expertise includes GCP/ICH, regulatory submissions, risk management, and program governance. The role emphasizes collaboration, operational excellence, patient safety, and driving digital and

Competenze

• Expert knowledge of GCP and ICH regulations.
• Deep understanding of end-to-end clinical development.
• Experience leading cross-functional teams globally.
• Strong project-management and budget oversight.
• Ability to navigate regulatory submissions.

Mansioni

• Leading and directing teams on program planning and governance meetings.
• Providing operational input at CST level during protocol design.
• Developing and maintaining the Clinical Operations Project Schedule.
• Overseeing enrollment, site feasibility, and patient engagement strategies.
• Resource planning and staffing across programs.
• Ensuring delivery of milestones and managing execution risks.
• Escalation point for trial teams on operational issues.
• Partnering on service provider strategy and contracts.
• Reviewing regulatory submissions and quality plans.
• Training and supervising Trial Managers and program leads.
• Championing digital proficiency and AI fluency to improve efficiency.

Conoscenze

GCP and ICH regulations

End-to-end clinical development

Project management

Cross-functional leadership

Regulatory submissions

Communication skills

Strategic planning

Leadership

Formazione

Bachelor's degree + 15 years

Master's + 12 years

PhD/PharmD + 8 years

Descrizione del lavoro

Merck & Co. in Rahway, NJ, seeks an experienced Clinical Operations leader to direct multi‑program development across disease areas. You will guide global, cross‑functional teams from protocol design to post‑approval, ensuring on‑time delivery and high quality in a fast-paced biotech environment.

Expected expertise includes GCP/ICH, regulatory submissions, risk management, and program governance. The role emphasizes collaboration, operational excellence, patient safety, and driving digital and