Director, Regulatory Affairs & Clinical Trials (Hybrid)

The University of Pittsburgh; Pittsburgh (Allegheny County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

The University of Pittsburgh's Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine seeks a Director of Regulatory Affairs to oversee regulated programs, coordinate IRB approvals, and support budgeting and contracting for clinical research.

Reporting to the Associate Chief for Strategy and Development, this role supervises research coordinators and partners with investigators and sponsors across multiple campuses, with hybrid on-site/remote work.

Qualifications

• Experience in regulatory affairs for clinical research programs.
• Strong budgeting and contracting coordination experience.
• Ability to coordinate IRB approvals with sponsors and investigators.
• Experience supervising and coordinating research staff.

Responsibilities

• Provide oversight of administrative, staffing, and clinical functions for regulated programs.
• Facilitate strategic planning, budget systems, and space management.
• Coordinate IRB approval, budgeting, and contracting with sponsors.
• Supervise the division's research coordinator staff.
• Develop a biosafety manual.

Skills

Regulatory affairs

Clinical trial budgeting

IRB coordination

Stakeholder liaison

CTMS knowledge

Education

Bachelor's Degree

Tools

Clinical Trial Management Systems

Job description

The University of Pittsburgh's Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine seeks a Director of Regulatory Affairs to oversee regulated programs, coordinate IRB approvals, and support budgeting and contracting for clinical research.

Reporting to the Associate Chief for Strategy and Development, this role supervises research coordinators and partners with investigators and sponsors across multiple campuses, with hybrid on-site/remote work.