Global Phase II Study Operations Director

cAMPfield Therapeutics, Inc.; Massachusetts; Hybrid; USD 180,000 - 260,000; Full time

Job summary

cAMPfield Therapeutics, Inc. seeks a Director, Study Lead to provide end‑to‑end operational leadership for a global Phase II study.

You will partner across Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, and CROs to ensure timely delivery, budget adherence, and high quality. Ideal candidates bring 10+ years of clinical operations experience, global study leadership, and track record in biotech environments.

Qualifications

• The candidate should have strong leadership and cross-functional collaboration skills.
• Solid regulatory knowledge and familiarity with ICH-GCP guidelines.
• Experience overseeing CROs and complex vendor ecosystems.

Responsibilities

• Lead development of the global study operational strategy, timelines, enrollment plan, and risk mitigation.
• Drive country and site selection strategy using data‑driven feasibility and patient insights.
• Partner with Clinical Development to ensure protocol feasibility and alignment with objectives.
• Oversee CRO performance, issue resolution, quality oversight, and KPI adherence.
• Lead global study team meetings and ensure cross‑functional alignment.
• Monitor enrollment, site performance, and vendor oversight; implement corrective actions.
• Ensure TMF completeness, inspection readiness, and data quality.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

ICH-GCP

Vendor management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

cAMPfield Therapeutics, Inc. seeks a Director, Study Lead to provide end‑to‑end operational leadership for a global Phase II study.

You will partner across Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, and CROs to ensure timely delivery, budget adherence, and high quality. Ideal candidates bring 10+ years of clinical operations experience, global study leadership, and track record in biotech environments.