Director, Phase I Ops — Lead Early-Phase Trials

BioTalent; Miami (FL); On-site; USD 155,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent in Miami, FL is seeking a Director of Clinical Operations (Phase I / Early Phase Clinical Research) to lead our Phase I programs. You will oversee study execution, ensure FDA, ICH and GCP compliance, and partner with investigators and site leadership to drive timely delivery.

The ideal candidate has a Bachelor's in a scientific field, 7–10 years in clinical operations and 5+ years in a senior leadership role, plus hands-on experience with patient recruitment and startup activities.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.
• Hands-on experience or exposure with patient recruitment.

Responsibilities

• Lead and mentor the Clinical Operations team to promote a collaborative and efficient environment.
• Ensure protocol compliance and maintain high-quality standards across all studies.
• Collaborate with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.
• Oversee staff recruitment, training, performance evaluations, and professional development.
• Monitor protocol adherence and manage the reporting of study deviations.
• Coordinate study assignments and support clinical research teams throughout study execution.
• Review study components prior to initiation and identify areas requiring clarification.
• Oversee study start-up, enrollment activities, and study close-out procedures.
• Support cross-functional collaboration with sponsors, investigators, and site leadership.
• Ensure compliance with FDA regulations, ICH guidelines, GCP standards, and company SOPs.

Skills

Clinical Operations

Leadership

FDA/ICH/GCP compliance

Education

Bachelor's degree in a scientific or healthcare-related field

Job description

BioTalent in Miami, FL is seeking a Director of Clinical Operations (Phase I / Early Phase Clinical Research) to lead our Phase I programs. You will oversee study execution, ensure FDA, ICH and GCP compliance, and partner with investigators and site leadership to drive timely delivery.

The ideal candidate has a Bachelor's in a scientific field, 7–10 years in clinical operations and 5+ years in a senior leadership role, plus hands-on experience with patient recruitment and startup activities.