"Director of Clinical Trials, Medicine"

Director of Clinical Trials, Medicine

Position Information

Position Title: Director of Clinical Trials, Medicine
Department: Medicine
Posting Link: https://www.ubjobs.buffalo.edu/postings/59463
Job Type: Full-Time

Position Summary

The University at Buffalo Department of Medicine seeks a highly motivated and experienced Director of Clinical Trials to lead and expand its clinical research infrastructure. This leadership role will oversee all aspects of clinical trial operations within the Department, including regulatory compliance, trial development, coordination, budgeting, and stakeholder engagement. The Director will work closely with faculty investigators, research coordinators, hospital affiliates, sponsors, and institutional offices to support investigator-initiated and industry-sponsored trials.

Key Responsibilities:

Leadership & Oversight:

• Direct and supervise the clinical trials operations team, including research coordinators and regulatory staff.
• Develop and implement strategic plans for clinical trials growth across divisions.
• Ensure trials are conducted in accordance with GCP, ICH, FDA, and IRB standards.

Operational Management:

• Manage study start-up activities including feasibility, protocol review, contract review, and budgeting.
• Develop and optimize workflows, SOPs, and quality assurance measures.
• Coordinate with clinical partners (e.g., UBMD Physicians’ Group, Kaleida Health, VA Western NY Healthcare System).

Compliance & Reporting:

• Serve as primary liaison for regulatory bodies and sponsor audits.
• Ensure timely submission of IRB protocols, continuing reviews, and adverse event reports.
• Oversee data integrity and compliance tracking systems.

Financial & Administrative Management:

• Collaborate with finance teams to prepare and manage trial budgets, billing compliance, and sponsor invoicing.
• Monitor and report on enrollment metrics, timelines, and revenue targets.
• Provide guidance on grant applications and funding opportunities related to clinical research.

Education & Training:

• Mentor research staff and faculty on clinical trial best practices.
• Conduct training on compliance, data management, and protocol implementation.

Learn more:

• Our benefits, where we prioritize your well-being and success to enhance every aspect of your life.
• Being a part of the University at Buffalo community.

As an Equal Opportunity / Affirmative Action employer, the Research Foundation will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, sexual orientation, gender identity, national origin and veteran or disability status.

Minimum Qualifications

• Bachelors degree with 5 years of experience.
• Experience in clinical research, including at least 3 years in a leadership or management role.
• In-depth knowledge of FDA regulations, GCP, and clinical trial operations.
• Experience working within academic medical centers or large health systems.

Preferred Qualifications

• Master’s degree in Clinical Research, Public Health, Healthcare Administration, Life Sciences, or related field.
• Familiarity with Epic, REDCap, OnCore, or similar CTMS platforms.
• Experience collaborating with investigators in Internal Medicine or related subspecialties.
• Knowledge of university or state research administration systems.

Salary Range

$110,000 - $120,000

Posting Dates

Posted: 10/14/2025
Deadline for Applicants: 10/29/2025