Associate Director Clinical Operations (Consultant)

Planet Pharma; Boston (MA); On-site; USD 170,000 - 250,000; Full time

Job summary

Planet Pharma in Boston is seeking an experienced Associate Director, Clinical Operations to lead a multinational Phase 2/3 trial. You will be the operational lead, partnering with cross-functional teams, investigators, and CROs to ensure study startup, execution, and closeout.

The role requires hands-on global study leadership with site activation, risk mitigation, and proactive management to ensure compliance with GCP and regulatory requirements while collaborating with Clinical Development,

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience leading Phase 2 and/or Phase 3 clinical trials.
• Proven track record managing global or regional clinical studies.
• Biotech, pharma, or CRO industry experience.

Responsibilities

• Lead clinical trial execution from startup through closeout.
• Manage study timelines, milestones, and deliverables.
• Drive site identification, activation, and enrollment strategies.
• Oversee CRO and vendor performance for quality and timelines.
• Collaborate with cross-functional teams (Clinical Development, Data Management, Biostatistics, Medical Monitoring, Regulatory).
• Identify operational risks and develop mitigations.
• Track progress and report to leadership.
• Ensure compliance with GCP, SOPs, and regulations.

Skills

Clinical ops leadership

Project management

Global studies

Regulatory compliance

Education

Bachelor's degree in Life Sciences

Job description

Position Summary

We are seeking an experienced Associate Director, Clinical Operations to lead the execution of a multinational Phase 2/3 clinical study. This individual will serve as the operational lead for the trial, partnering with cross-functional teams, investigators, and CROs to ensure successful study startup, execution, and closeout.

The ideal candidate is a hands‑on clinical operations leader with experience managing global studies, driving site startup activities, and overseeing CRO performance. This role requires strong project management skills, the ability to operate independently, and a proactive approach to identifying and mitigating study risks.

Key Responsibilities

• Lead clinical trial execution from startup through closeout.
• Manage study timelines, milestones, and operational deliverables.
• Drive site identification, selection, activation, and enrollment strategies.
• Oversee CRO and vendor performance to ensure quality and timeline adherence.
• Collaborate with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Regulatory, and other cross-functional teams.
• Identify operational risks and develop mitigation strategies.
• Track study progress and provide regular updates to leadership.
• Ensure compliance with GCP, SOPs, and applicable regulatory requirements.
• Support investigator and site relationship management throughout the study lifecycle.

Qualifications

Required

• Bachelor’s degree in Life Sciences or related discipline.
• Significant Clinical Operations experience within the biotechnology, pharmaceutical, or CRO industry.
• Experience leading Phase 2 and/or Phase 3 clinical trials.
• Proven success managing global or regional clinical studies.