UC San Diego Health
Manager, Regulatory Affairs - Hybrid - 134458
UC San Diego Health, San Diego, California, United States, 92189
Overview
This position will remain open until a successful candidate has been identified. Special Selection Applicants: Apply by 03 / 12 / 2025. 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 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. It is a collaborative partnership between UCSD, encompassing 28 departments, 6 schools, UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the translational research of the La Jolla Institute of Immunology (LJI). These programs are dedicated to fulfilling MCC's mission of reducing cancer burden. MCC offers challenging career opportunities in a fast-paced and innovative environment with opportunities for cross-training, professional development, and progressive responsibility. MCC's mission is to transform cancer care by driving scientific discoveries and innovations in prevention, detection, care, and training, with core values of 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 programmatic responsibilities. The Regulatory Manager collaborates with training and education specialists to strengthen 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. The Regulatory Manager serves as a liaison between MCC CTO and stakeholders, including 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 role includes designing research projects of significant scale and complexity and leading these projects with knowledge of clinical research protocols and processes. The role includes managing a team in a matrixed organization to ensure activation targets are met and ongoing regulatory compliance for all active clinical trials under the CTO. It includes supervising professionals, advising administration, interpreting policies, and ensuring accountability and stewardship of resources. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials. Apply extensive knowledge of clinical research protocols to design large-scale projects and provide direction on programmatic efforts and systems to streamline regulatory processes. Develop new processes and policies with project teams for highly complex trials, coordinate data from multiple systems, and ensure compliance with guidelines. Develop regulatory policies and inform personnel about research policies. Perform regulatory checks and develop checklists for compliant trial activation and ongoing guidance to streamline activation processes. Experience with e-Regulatory systems is preferred. MINIMUM QUALIFICATIONS Nine years of related experience, education/training, OR a Bachelor's degree in a 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, with ability to translate philosophy into business best practices in a trial setting. Demonstrated project management skills, ability to manage multiple priorities in a fast-paced environment, and adaptability to changing priorities. Experience managing people with diverse educational backgrounds and skills, with conflict resolution, training, and leadership capabilities. Strong problem-solving and analytical skills. Strong verbal and written communication, active listening, critical thinking, and negotiation skills. Ability to influence and advise stakeholders effectively. Excellent interpersonal skills, including teamwork, leadership, mentorship, and relationship-building with multiple stakeholders at various levels of administration. Proficiency in word processing and spreadsheet software, and experience with clinical information/documentation applications and clinical trial management systems. Ability to collaborate across cross-functional teams and coordinate programs with others in the division/department/organization. PREFERRED QUALIFICATIONS Advanced degree. SPECIAL CONDITIONS Employment is subject to a criminal background check. Pay Transparency Act Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent
: $46.55 - $87.16 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
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This position will remain open until a successful candidate has been identified. Special Selection Applicants: Apply by 03 / 12 / 2025. 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 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. It is a collaborative partnership between UCSD, encompassing 28 departments, 6 schools, UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the translational research of the La Jolla Institute of Immunology (LJI). These programs are dedicated to fulfilling MCC's mission of reducing cancer burden. MCC offers challenging career opportunities in a fast-paced and innovative environment with opportunities for cross-training, professional development, and progressive responsibility. MCC's mission is to transform cancer care by driving scientific discoveries and innovations in prevention, detection, care, and training, with core values of 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 programmatic responsibilities. The Regulatory Manager collaborates with training and education specialists to strengthen 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. The Regulatory Manager serves as a liaison between MCC CTO and stakeholders, including 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 role includes designing research projects of significant scale and complexity and leading these projects with knowledge of clinical research protocols and processes. The role includes managing a team in a matrixed organization to ensure activation targets are met and ongoing regulatory compliance for all active clinical trials under the CTO. It includes supervising professionals, advising administration, interpreting policies, and ensuring accountability and stewardship of resources. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials. Apply extensive knowledge of clinical research protocols to design large-scale projects and provide direction on programmatic efforts and systems to streamline regulatory processes. Develop new processes and policies with project teams for highly complex trials, coordinate data from multiple systems, and ensure compliance with guidelines. Develop regulatory policies and inform personnel about research policies. Perform regulatory checks and develop checklists for compliant trial activation and ongoing guidance to streamline activation processes. Experience with e-Regulatory systems is preferred. MINIMUM QUALIFICATIONS Nine years of related experience, education/training, OR a Bachelor's degree in a 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, with ability to translate philosophy into business best practices in a trial setting. Demonstrated project management skills, ability to manage multiple priorities in a fast-paced environment, and adaptability to changing priorities. Experience managing people with diverse educational backgrounds and skills, with conflict resolution, training, and leadership capabilities. Strong problem-solving and analytical skills. Strong verbal and written communication, active listening, critical thinking, and negotiation skills. Ability to influence and advise stakeholders effectively. Excellent interpersonal skills, including teamwork, leadership, mentorship, and relationship-building with multiple stakeholders at various levels of administration. Proficiency in word processing and spreadsheet software, and experience with clinical information/documentation applications and clinical trial management systems. Ability to collaborate across cross-functional teams and coordinate programs with others in the division/department/organization. PREFERRED QUALIFICATIONS Advanced degree. SPECIAL CONDITIONS Employment is subject to a criminal background check. Pay Transparency Act Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent
: $46.55 - $87.16 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
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