Manager, Regulatory Affairs - Hybrid - 134458

The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees includingopportunities for cross-training, professional development, and progressive responsibility.

MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.

The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.

Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities. With a focus on program enhancement, the Regulatory Manager collaborates closely with training and education specialists to strengthen key regulatory practices for Regulatory Coordinators, Clinical Research Coordinators and Data Coordinators. This involves creating and maintaining standard operating procedures, written instructions, and templates to streamline and optimize regulatory processes. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.

The incumbent demonstrates expertise in regulatory matters, serving as a subject matter expert when engaging with sponsors and auditors. The scope of the incumbent's responsibilities extends to designing research projects of significant scale and complexity. Their extensive knowledge of clinical research protocols and processes enables them to lead these ambitious projects, contributing to the MCC CTO's overall success.

Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO's activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO's purview. Provides direct supervision typically to professionals or skilled technical employees. Functions as advisor to unit and administration. Analyzes and resolves problems, interprets policies (e.g., fiscal management, HR, contracts and grants, resource management in defined areas) and demonstrates solid subject matter knowledge. Exercises judgment within defined procedures and policies to determine appropriate action. Supervises staff to assure accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental goals and objectives.

Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. Provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner. Function as a lead in development of new processes and policies with project team for highly complex clinical trials, along with other UCSD teams / departments. Monitor, evaluate and coordinate data from multiple systems to recommend new actions / procedures from research analysis. Assess policies and processes to ensure the proposed project plan is compliant with applicable guidelines. Ensure reporting is consistent with external guidelines, university policies and regulations. Develop and inform regulatory personnel about research policies. Perform regulatory checks and develop checklists to confirm compliant clinical trial activation, and provide ongoing guidance to team members to streamline clinical trial activation processes in the realm of regulatory affairs. Knowledgeable and has experience working with e-Regulatory systems.

• Nine years of related experience, education/training, OR a Bachelor's degree in related area plus five years of related experience/training.

• Clinical Trial Professional certification from a professional society within one year in position.

• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.

• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.

• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.

• Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.

• Advanced degree.

• Employment is subject to a criminal background check.

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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!

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a. "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace