Director of Regulatory Affairs

University of Pittsburgh; Pittsburgh (Allegheny County); Hybrid; USD 130,000 - 170,000; Full time

Job summary

The University of Pittsburgh is seeking a Director of Regulatory Affairs within the Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine. This role provides regulatory planning and budgeting support for clinical trials, coordinating IRB approvals and contracting with sponsors, and reports to the Associate Chief for Strategy and Development.

The position supervises the division's research coordinators and interfaces with principal investigators to ensure regulatory compliance and

Qualifications

• Bachelor's degree required in a relevant field.
• 7+ years of regulatory/clinical research experience.
• Experience with budgeting, contracting, and IRB coordination.

Responsibilities

• Lead Division's Research Coordinator Staff.
• Direct the Development of Clinical Trial Budgets.
• Collaborate and Liaise with Internal and External Stakeholders.
• Support the Development and Maintenance of Regulatory-compliant Processes.
• Be a Subject Matter Expert on Relevant Clinical Trial Management Systems.

Skills

Regulatory affairs

Clinical research

Budget development

IRB coordination

Contracting

Education

Bachelor's Degree

Tools

CTMS

Budgeting software

Job description

Job Description - Director of Regulatory Affairs (26006426)

Director of Regulatory Affairs

Med-Medicine - Pennsylvania-Pittsburgh - ( 26006426 )

The Pulmonary, Allergy, Critical Care, and Sleep Medicine Division is made of up approximately 70 clinical staff and over 100 research staff who work in a variety of locations including: Bridgeside Point, Biomedical Science Tower (BST), UPMC Hospitals including Presbyterian, Shadyside, East, Jameson and Mercy. The division provides world class services across 10 inpatient services at five hospitals and over 70,000 outpatient office visits. We have a major research mission that focuses on basic, clinical, and translational research on the lung, microbiome, COVID-19, sleep medicine, and allergy and immunology.

The Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine invites applications for the position of Director of Regulatory Affairs. This position supports the division and its investigators by providing clinical trial planning, budgeting, and regulatory support. This position will work closely with experienced principal investigators and project coordinators within internationally recognized and impactful lung research programs to coordinate IRB approval, budget development and contracting with local sponsor stakeholders. This position will report to the Associate Chief for Strategy and Development Director of Faculty Development and supervise the division's research coordinator staff.

Job Summary

Provides oversight and supervision of all administrative, staffing, and clinical functions for highly regulated programs, projects, and initiatives within a research program.Facilitates strategic planning, budgetary systems and cost models, and space management. Acts as signatory authority and oversees all reporting functions. Develops a biosafety manual.

Essential Functions

• Lead Division's Research Coordinator Staff
• Direct the Development of Clinical Trial Budgets
• Collaborate and Liaise with Internal and External Stakeholders
• Support the Development and Maintenance of Regulatory-compliant Processes
• Be a Subject Matter Expert on Relevant Clinical Trial Management Systems

Physical Effort

Must be able to sit/stand for up to 8 hours.

The University of Pittsburgh is an equal opportunity employer / disability / veteran.

Assignment Category Full-time regular

Job Classification Staff.Director - Clinical Research Operations

Job Family Research

Job Sub-Family Clinical Research

Campus Pittsburgh

Minimum Education Level Required Bachelor's Degree

Minimum Years of Experience Required 7

Will this position accept substitution in lieu of education or experience? Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule Monday – Friday, 8am-4:30pm

Work Arrangement Hybrid: Combination of On-Campus and Remote work as determined by the department.

Hiring Range TBD Based Upon Qualifications

Relocation Offered No

Visa Sponsorship Provided Yes

Background Check For position finalists, employment with the University will require successful completion of a background check

Child Protection Clearances Not Applicable

The University of Pittsburgh is an equal opportunity employer / disability / veteran.