Senior Director, Global Clinical Programs & Ops

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

Vantaggi offerti da questo lavoro

Hybrid work arrangement

Comprehensive benefits

Descrizione del lavoro

Merck & Co. in Rahway, NJ seeks a senior leader to guide complex global clinical development programs across disease areas.

You will lead cross-functional teams, drive strategic planning, scheduling, regulatory input, and risk management from protocol design through post-approval, with direct and indirect reports. The role requires advanced experience in GCP/ICH, ICH regulations, and digital/AI-enabled process improvements, with a track record of optimizing trial operations, stakeholder

Competenze

• Bachelor's degree plus 15 years pharmaceutical/clinical drug development experience.
• Master's degree with 12+ years in pharma/clinical development.
• PhD/PharmD with minimum 8 years in pharmaceutical/clinical drug development experience.

Mansioni

• Lead global, cross-functional teams in end-to-end clinical development from planning to post-approval.
• Develop and manage Clinical Operations schedules and milestones for multiple programs.
• Oversee enrollment planning, site feasibility, and patient engagement strategies across trials.
• Ensure inspection readiness and resolve program-level quality and regulatory issues.
• Collaborate with QA, regulatory, and PSRM on strategy and execution.

Conoscenze

GCP & ICH

Clinical research

AI-enabled

Digital transformation

Cross-functional leadership

Project management

Regulatory submissions

Stakeholder collaboration

Data management

Formazione

Bachelor's degree + 15 years

Master's + 12 years

PhD/PharmD + 8 years

Descrizione del lavoro

Merck & Co. in Rahway, NJ seeks a senior leader to guide complex global clinical development programs across disease areas.

You will lead cross-functional teams, drive strategic planning, scheduling, regulatory input, and risk management from protocol design through post-approval, with direct and indirect reports. The role requires advanced experience in GCP/ICH, ICH regulations, and digital/AI-enabled process improvements, with a track record of optimizing trial operations, stakeholder