Global Phase I Clinical Program Lead

Planet Pharma; New York (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Program Manager to lead a global Phase I program from initiation to execution. You will oversee trials, budgets, timelines and CRO partnerships within a fast-paced biotech environment.

The role requires hands-on leadership of Clinical Trial Managers, cross-functional collaboration with regulatory, data management and development teams, and a focus on delivering studies on time and in compliance with ICH-GCP and SOPs.

Qualifications

• 8+ years in clinical research or Clinical Operations within biotech/pharma/CRO environments.
• Experience leading phase I programs from planning to execution.
• Strong knowledge of ICH-GCP, FDA regulations and global trial requirements.
• Direct management of Clinical Trial Managers or similar roles.

Responsibilities

• Provide program-level operational leadership for a global Phase I program.
• Lead start-up, planning and execution of SAD and MAD studies.
• Manage Clinical Trial Managers and oversee CRO/vendor governance and performance.
• Develop integrated program plans, timelines, budgets, resources and risk mitigation.
• Coordinate cross‑functional activities with Clinical Development, Regulatory Affairs and Data Management.

Skills

Clinical trial leadership

Phase I trials

Budget management

Vendor management

Cross-functional leadership

Veeva CTMS

Regulatory knowledge

Education

Bachelor's degree in science or related field

Advanced degree preferred

Tools

Veeva CTMS

eTMF

Job description

Planet Pharma is seeking a Senior Clinical Program Manager to lead a global Phase I program from initiation to execution. You will oversee trials, budgets, timelines and CRO partnerships within a fast-paced biotech environment.

The role requires hands-on leadership of Clinical Trial Managers, cross-functional collaboration with regulatory, data management and development teams, and a focus on delivering studies on time and in compliance with ICH-GCP and SOPs.