In 2022, businessman and philanthropist T. Denny Sanford committed $150 million to the creation of the Sanford Stem Cell Institute at UC San Diego. This gift combines current infrastructure with new Centers intended to leverage the advantages of space-based science, including expansion and, in some ways, quite literally launch stem cell research and regenerative medicine at UC San Diego into new spaces, endeavors, and training of future stem cell scientists.

Sanford Stem Cell Institute provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, daily Sanford Stem Cell Institute personnel work with all 9 Vice Chancellor areas: Academic Affairs; Research Affairs; Equality, Diversity, and Inclusion; Student Affairs; Marine Sciences; Health Sciences; Health System; Chief Financial Officer; Advancement; Resource Management and Planning.

As part of UC San Diego, Sanford Stem Cell Institute motivates University-wide change, sustainability, and partnership, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed.

The new UC San Diego Sanford Stem Cell Institute builds upon a $100 million gift in 2013 from T. Denny Sanford that established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells - special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases.

The new UC San Diego Sanford Stem Cell Institute includes six (6) stem cell Centers led by Center Directors and Deputy Directors.

1.Sanford Integrated Space Stem Cell Orbital Research (ISSCOR) Center, for stem cell research that will be conducted in a laboratory bay located aboard the International Space Station currently in low-Earth orbit.

2.Sanford Stem Cell Fitness and Space Medicine Center, which conducts in-depth space fitness and orbital medicine that can benefit both astronauts and people living on Earth.

3.Sanford Stem Cell Innovation Center, which will support regenerative medicine company development, including contract research in low-Earth orbit.

4.Sanford Stem Cell Discovery Center, which conducts basic and translational stem cell research.

5.Sanford Advanced Therapy Center, which provides fundamental tools and services to move basic research findings to next stages, such as early phase trials.

6.Sanford Stem Cell Clinical Center, which conducts research to accelerate relevant drug and therapy development in regenerative medicine, including clinical trials.

Reporting to the Director of Clinical Research, within the UC San Diego Alpha Clinic, the Regulatory Manager 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 Alpha Clinic 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 UC San Diego Alpha Clinic's overall success.

Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the UC San Diego Alpha Clinic's activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the UC San Diego Alpha Clinic'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 Regulatory unit to support compliant study activation and management of active clinical trials managed by the UC San Diego Alpha Clinic. 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.

Supervises staff responsible for working with departments, staff, patients and families in using clinical research techniques. May assume full responsibility for the research in delegated studies. Receives assignments in the form of objectives with goals and the processes by which to attain them. Supervises daily operations, and performance requirements. Has full oversight for staffing, performance management, and programmatic workflow of project.

• Seven years of related experience, education/training, OR an Bachelor's degree in related area plus three years of related experience/training.

• 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.

• 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.

• 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 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.

• 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.

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

• Employment is subject to a criminal background check.