Job Description

Payroll Title:
CLIN RSCH ANL 5
Department:
CANCER CENTER/ Clinical Trials
Salary Range
Commensurate with Experience
Worksite:
Moores Cancer Center
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
1
Work Schedule:
Days, 8 hrs/day, Monday-Friday

As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.

#118560 Associate Director, Clinical Trials Office

Initial Review Date: Mon 9/26/2022

For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy

Special Selection Applicants: Apply by 09/23/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.

This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.

DESCRIPTION

UC San Diego Moores Cancer Center (MCC) is one of only 40 National Cancer Institute-designated Comprehensive Cancer Centers in the United States. This designation is reserved for cancer centers with the highest achievements in cancer research, clinical care, education, and community contributions. Moores Cancer Center strives to stay at the forefront of emerging cancer research in a patient centric environment. Principal Investigators (PIs) in the MCC conduct clinical trials to test new treatments for people affected by cancer with the goal of finding better ways to prevent cancer, treat cancer, and care for cancer patients.

The Associate Director, Clinical Trials Office (CTO) for the Moores Cancer Center reports to the Administrative Director. As the second most senior manager in the CTO, the Associate Director serves as a senior administrative leader in the Cancer Center with leadership and management authority for several key functions of the clinical research enterprise, including all data management, compliance, regulatory affairs, and personnel business matters. Responsible for working directly with the Senior Deputy Director for Clinical Research on grant and research development and will provide critical decision support to CTO and Cancer Center faculty and administrative leadership on clinical research initiatives. Responsible for high level project management, strategic planning and guidance on performance and improvement initiatives, and mentorship and coaching of other team members. The AD will also have fiscal oversight which includes review of the budget and vendor agreements.

The Associate Director will lead and contribute to organizational implementation of e-regulatory systems providing feedback to organization-wide technology initiatives such as Oracle, Epic Research Module, e-regulatory systems for all research groups and third-party contracting such as commercial IRB and budgeting. Oversee development and maintenance of a new Phase 1 Unit for oncology due to increase of Phase 1/Early phase trials as well as cellular therapy and personalized vaccine trials. The clinical trials are extremely complex requiring newly developed SOPs, departmental workflows across multiple departments.

The Associate Director serves as a mentor and trainer to other supervisor roles in the department, mentoring new members and coaching others through new processes. Serves as part of a taskforce aimed at eliminating barriers to activating clinical research to identify bottlenecks and improvement initiatives. As a recognized research expert, applies comprehensive knowledge of clinical research protocols and processes to lead the most complex projects of critical impact.

MINIMUM QUALIFICATIONS

  • Bachelor’s degree in related area plus a minimum of seven (7) years related experience; OR equivalent combination of related experience, education and training.

  • Expert knowledge of clinical research practices and philosophy and expert ability to translate clinical research philosophy into business best practices in a trial setting. Expert knowledge of regulatory requirements.

  • Expert project management skills. Demonstrated adaptability and flexibility to lead multiple complex, high impact projects and teams. Anticipates and effectively handles change. Expert skills to drive a project from idea generation and initiation through start-up and maintenance throughout.

  • Expert critical thinking skills to challenge conventional practices, adapt established methods for improved uses, pursue ongoing system improvement, create novel solutions to problems, and evaluate new concepts as potential solutions to existing problems.

  • Highly developed communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Expert ability to influence and negotiate.

  • Highly skilled interpersonal skills, including but not limited to: problem-solving, teamwork development, mentoring and leadership with other team members. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of organization.

  • Expert ability to perform all commonly applicable functions in word processing and spreadsheet software. Expert knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

  • Demonstrated strong leadership, management, strategic planning, supervisory, and consensus building skills. Working knowledge and ability to apply effective management skills principle and practices to successfully administer and lead a large and complex clinical trials unit.

  • In-depth knowledge of UC, FDA, HCFA, and state/federal billing compliance policies/ procedures. Experience working with FDA policies regulating clinical trials.

  • Expert analytical, business, and statistical skills.

  • Expert knowledge of government regulations and compliance issues regarding clinical research and protection of human subjects and compliance with special regulations for academic institutions.

  • Demonstrated experience overseeing the preparation and review of the clinical research/ clinical trial budget preparation and negotiation to ensure appropriate resource allocation and cost accounting standards for clinical trials.

  • Expert working knowledge of pharmaceutical industry negotiating strategies and contract law. This includes the promotion, negotiation and execution of industry sponsored contracts and budget preparation.

  • Knowledge of hematology/ oncology and oncology clinical research. Experience differentiating various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization.

  • Experience in analyzing large quantities of research data, extract pertinent data, analyze and present data effectively. Experience writing oncology reports and/or research and analytical studies that are communicated to academic administrative audiences.

  • Demonstrated experience in clinical data management and Electronic Data Capture (EDC) systems, such as Epic, CTSU, CTRP, CTMS/Velos, etc.

PREFERRED QUALIFICATIONS

  • Advanced degree in public health, clinical research, business management, or other related field.
  • Experience in oncology clinical trials strongly preferred.
  • Background and theoretical knowledge in a biological science.
  • CCRP certification

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check and pre-employment physical.
  • Must be able to work various hours and locations based on business needs.
  • Must have ready access to reliable transportation and be willing to travel off-site.
  • Must be willing to complete ethics training.

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

Application Instructions

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