The Technical Director of the Pharmacoanalytical Shared Resource (PhASR) will directly supervise managers and individual contributors who are conducting research studies to support users of PhASR services, as well as manage relationships with OSUCCC leadership, college departments, external sponsors, clinical and non-clinical investigators, suppliers, and contractors as they relate to PhASR studies. The Technical Director will direct and oversee the operational research and activities of PhASR staff for clinical and non-clinical research studies.

Responsibilities Include:

• Participates with PhASR and OSUCCC leadership in the short and long-term strategic planning activities

• Disseminates plans and directives to investigators and their staff/trainees and to PhASR staff to effectively and efficiently carry out activities to meet established project goals and objectives

• Disseminates plans and directives to PhASR staff to effectively and efficiently meet established strategic goals and objectives

• Serves as lead liaison with investigators to monitor project portfolios, staff workload and quality of services

• Determines and assigns actions to address problems with follow-up to ensure compliance in the conduct of GLP and non-GLP research and adherence to FDA and protocol requirements

• Oversees the coordination and management of project completion for clinical and non-clinical studies in accordance with protocol, CFR, FDA, and other internal and external regulatory and quality standards

• Plans and oversees new and/or revised policies and procedures to address quality assurance issues and to meet requirements of new research protocols

• Manages relationships with related entities including staff, investigators, physicians and laboratory and administrative staff as needed

• Interfaces with external sponsors, monitors and auditors

• Develops and implements processes among research staff for all clinical and non-clinical study-related activities including: development of detailed protocols, documentation, quality assurance, and follow-up as well as reporting

• Ensures that all data on clinical and non-clinical samples for each study is recorded in a timely and appropriate manner

• Directs all bioanalytical operations of the Pharmacoanalytical Shared Resource (PhASR) within the Comprehensive Cancer Center

• Implements strategic plans for research consistent with the OSU Comprehensive Cancer Center in conjunction with the PhASR Director

• Collaborates with research investigators to assist them in completing the specific aims of research projects as they relate to research design and measurement, regulatory compliance, data collection, and data management

• Directs the development and execution of procedures for data collection and quality control

• Designs and implements investigator and staff trainings for specialized sample collection, sample processing, data collection, data entry and management

• Directs the hiring, training and oversight of PhASR staff

• Oversees preparation of PhASR reports, progress reports of services completed for research projects conducted through the PhASR

• Develops outcomes reports to evaluate the effectiveness of PhASR operations and services and recommends changes as needed

• In addition to these broad managerial activities, the PhASR Technical Director applies in-depth knowledge of liquid chromatography-mass spectrometry and its application to ensure optimal use of PhASR equipment and staff time

• Ensures maintenance of all laboratory equipment by directing routine maintenance and scheduled contracted maintenance services when necessary

• Participates in conferences related to the progress of studies and presents PhASR capabilities and experimental data at local and national meetings

• Prepares manuscripts and grant proposals to governmental and private agencies, including writing sections of investigator manuscripts and grant proposals

• Completes all other activities as requested from the OSUCCC leadership and the PhASR Director in order to facilitate the research and service objectives of the OSUCCC

MINIMUM QUALIFICATIONS:

• Bachelors degree or equivalent experience is required, Doctoral degree in an appropriate field with postdoctoral training is preferred.

• Requires 5 years experience in bioanalytical chemistry, regulated laboratory experience (CLIA, CAP and/or FDA audits), and program management experience.

• 8-12 years experience preferred as a bioanalytical chemist with 5 of those in a regulated laboratory (CLIA, CAP, and/or FDA audits) and 2 years in program management.

• Extensive mass spectrometry experience in quantitating small molecules in biological matrices.

• Experience in industry, government, and university laboratories with considerable experience in a R amp; D setting (i.e., planning and conducting R amp; D projects/programs in terms of technical and managerial functions), extensive experience in FDA guidance for bioanalytical assay validation is required.

• Requires successful completion of a background check; selected candidate may be asked to complete a pre-employment physical including a drug screen.

Function: Research and Scholarship

Sub function: Research

Career Band: People Leader Managerial

Career Level: M2

The Ohio State University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

The Ohio State University is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. The Ohio State University is one of the nations largest and most comprehensive public universities and a top employer in Ohio.

As one of only 54 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies providing tomorrows standard of care today. A Cancer-Free World Begins Here.

The OSUCCC James is the only cancer program in the United States that features a National Cancer Institute (NCI)-designated comprehensive cancer center aligned with a nationally ranked academic medical center and a freestanding cancer hospital on the campus of one of the nations largest public universities. is the only cancer program in the United States that features a National Cancer Institute (NCI)-designated comprehensive cancer center aligned with a nationally ranked academic medical center and a freestanding cancer hospital on the campus of one of the nations largest public universities.

Salary Range for this position: $92,000 - $123,000