Senior Clinical Trial Lead (Phase II–III) – Global Operations

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work schedule

Travel opportunities

Job summary

MBX Biosciences is seeking a Senior Clinical Trial Manager to lead the operational execution of Phase II/III studies across development programs. The role oversees startup through closeout, ensuring GCP compliance, timelines, and strong cross-functional collaboration in a fast-paced biotech environment.

The ideal candidate has 8+ years in clinical research, including 3+ years in a leadership role, with experience managing CROs and external vendors.

Qualifications

• 8+ years of clinical research experience with leadership exposure.
• Experience managing Phase II/III trials in biotech/pharma.
• Strong knowledge of ICH-GCP, FDA regulations, and global trial conduct.
• Experience leading CROs and external vendors.

Responsibilities

• Lead day-to-day operational management of Phase II and Phase III trials from startup through closeout.
• Serve as the primary operations lead for assigned studies and report to leadership.
• Develop and maintain study timelines, enrollment projections, risk management, and metrics.
• Identify, escalate, and resolve study-related issues; proactively mitigate risks to trial execution.
• Oversee CROs and external vendors to ensure quality, scope, timelines, and budget.

Skills

Clinical ops leadership

Cross-functional collaboration

CRO/vendor mgmt

ICH-GCP FDA knowledge

Study startup/closeout

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

CTMS

Job description

MBX Biosciences is seeking a Senior Clinical Trial Manager to lead the operational execution of Phase II/III studies across development programs. The role oversees startup through closeout, ensuring GCP compliance, timelines, and strong cross-functional collaboration in a fast-paced biotech environment.

The ideal candidate has 8+ years in clinical research, including 3+ years in a leadership role, with experience managing CROs and external vendors.