The Program Director is responsible for providing contract-research oversight for drug, biomarker, and medical device development under the supervision of the Division of Translational Radiation Sciences (DTRS) senior management in the Department of Radiation Oncology. This position is responsible for ensuring all work is performed in accordance with department Standard Operating Procedures (SOPs), animal welfare regulations, the Guide for the Care and Use of Laboratory Animals, Public Health Services (PHS), Office of Laboratory Animal Welfare (OLAW), Association for assessment and Accreditation of Laboratory Animal Care (AAALAC), Institutional Animal Care and Use Committee (IACUC) guidelines, and/or United States Food and Drug Administration (USFDA) 21CFR58 Good Laboratory Practice (GLP) regulations. Under limited supervision, this position uses subject matter expertise to capture and manage new contract research awards within the DTRS. This position sets goals and creates tactics to achieve program objectives to ensure Division compliance with the U.S. Food and Drug Administration Good Laboratory Practice regulations. Ensures timeline and deadlines are met.
This is an exempt, regular position and offers a generous benefits package that includes 22 vacation days, 14 floating and observed holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Responsible for federal contract management under the supervision of the Division's senior leadership, including serving as the primary point-of-contact for contract deliverables and milestones.
Serve as a single point of control to ensure oversight of GLP-compliant preclinical studies in support of United States and international regulatory submissions, including but not limited to Investigational New Drug (IND) and New Drug Application (NDA);
Responsible for ensuring GLP and non-GLP studies remain on scope, on time, and on budget.
Prepares study protocols, monthly, quarterly, and annual reports, final study reports, presentation of results at national and international conferences, and manuscripts for peer-reviewed publication.
Prepares, coordinates, and maintains program content and delivery methods for the daily operations under federally- and industry-funded contracts.
Cross-cutting coordination with project team to facilitate study execution.
Coordinates the use of databases used to analyze criteria and deliver data, as well as to monitor, evaluate, and revise program operating policies and procedures.
Organizes and/or participates in various committees and teams to consult with program heads and administrative officials on policy and program needs as well as various administrative issues.
Manages the regular publication of summary reports and serves as an information resource to coworkers, the university, and external figures.
Develops funding sources for the program, through grant seeking, major fundraising events and/or donations.
Performs other duties as assigned.
Education: Bachelor's degree in a related field.
Experience: Six (6) years working in an appropriate field with at least two (2) years of experience of overall responsibility for program direction, coordination and implementation.
Supervisory: Prior supervision of others preferred.
Preferred Education: Doctor of philosophy (PhD)-level scientist.
Other: No substitution of experience for minimum education requirement.
Hiring Range: Commensurate with education and experience.
If accommodations are needed, contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans and individuals with disabilities are encouraged to apply.
Job: Reg or CII Exempt Staff - E1429G
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: Radiation Oncology
Job Posting: Feb 14, 2018
Unposting Date: Mar 1, 2018, 4:59:00 AM
Internal Number: 82042
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.