DESCRIPTION

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.

The Director of Clinical Research oversees and manages the CIRM UC San Diego Alpha Clinic's research operations. The Director of Clinical Operations will also work closely with the Director and Deputy Director of the Sanford Stem Cell Clinical Center as well as the Program Director of the CIRM UC San Diego Alpha Clinic Grant. This position oversees and implements all tasks related to clinical research operations functions, including patient recruitment, clinical trials, program development, regulatory compliance, and financial strategies. The Director of Clinical Research provides supervision to CIRM UC San Diego Alpha Clinic staff of all levels and disciplines, including project coordination, participating in developing, training, and maintaining processes and procedures.

The CIRM UC San Diego Alpha Clinic is the clinical unit of the Sanford Stem Cell Clinical Center(SSCCC), under the umbrella of the Sanford Stem Cell Institute(SSCI), and specializes in early-phase, first-in-human trials. The Sanford Stem Cell Clinical Center is devoted to accelerating the translation of all types of stem cell research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel stem cell clinical trials and ancillary studies for a range of difficult diseases. The Sanford Stem Cell Clinical Center is a wide-ranging collaboration with unique contributions from UC San Diego Health, the Sanford Consortium for Regenerative Medicine, industrial sponsors, and philanthropy launched by the $100M Sanford Gift and continued with the $150M Sanford Gift, and by CIRM through the Alpha Clinic and other grants.

The Director of Clinical Research promotes new clinical trials and guides direction with industry and cooperative groups, works collaboratively with the SSCI Industry Liaison Officer, outside affiliates, represents the SSCCC both internally and externally, and identifies barriers to successful clinical trials execution and fosters approaches toward reducing barriers. The incumbent will coordinate efforts with the 8 other CIRM Alpha Clinics in the state to promote cross-collaboration and sharing of network tools. The incumbent will coordinate activities among the SSCI clinical functional groups (Clinical Operations--includes regulatory & clinical coordinators, data team, the KOP Sanford Stem Cell Outpatient clinic team, and the Cell and Regenerative Medicine (CRM) inpatient APPs and providers), the PI's of each trial, and will build a collaborative team focused on the efficient performance of clinical trials. Responsible for working with the SSCCC leadership team, SSCI Executive Director, and CIRM Alpha Clinic Program Director to ensure clinical trial resources are continuously adequate; participates in the interview and selection of clinical operations personnel. Allocates resources with focus on efficiency, time-lines and project deliverables.

The incumbent is responsible for providing the Program Director of the CIRM UC San Diego Alpha Clinic and other leadership with information/data to contribute to strategic planning efforts to ensure that Clinical Operations keeps pace with planned stem cell clinical trials. The Director of Clinical Research oversees successful project management, and provides overall supervision, mentorship, and training to project managers, project coordinators, regulatory and data managers, as well as other clinical operations staff. The Clinical Operations Director provides project coordination to clinical operations staff, participates in developing, training, and maintaining Standard Operating Procedures, and assists in grant writing and regular reports. Responsible for the development and revision of clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory, and clinical standards. Provides input to the clinical operations portion of proposals, budgets and contracts. Provides support to the daily conduct of ongoing communication responding to inquiries from clinical sites and project team members; addresses client requests, as applicable. Performs other related director functions as required.

The Director of Clinical Research manages operations, including administrative and budget functions, for a clinical research initiative or clinical research program. Receives research objectives and defines subordinate goals in order to achieve those objectives.

MINIMUM QUALIFICATIONS

• Thirteen years of related experience, education/training, OR an Master’s degree in related area plus seven years of related experience/training.

• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials. Demonstrated experience in clinical research data collection, database management and data analysis. Broad knowledge of the fundamentals of statistical design and analysis of clinical trial data. Proven experience in maintaining quality control in coordinator and data manager related responsibilities. In-depth knowledge and understanding of audit requirements involving interpreting regulations, guidelines, and compliance issues. Experience in conducting multi-center clinical trials.

• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research. Advanced knowledge of regulations pertaining to HIPAA and GCP.

• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues.

• Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities.

• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and 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. Possess skills of tact, poise, diplomacy, confidentiality and flexibility. Ability and willingness to work independently and in a team framework in conjunction with principles of community and with a diverse population of staff, faculty, industry and others. Ability to effectively lead and participate in discussions regarding procedures and goals of unit.

• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution. Advanced experience in project management, including ability to multi-task and re-prioritize deliverables as necessary to meet tight timelines. Demonstrates calm under pressure.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.

• Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial. Ability to be effective in a fast-paced environment with changing priorities.

• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software. Proven ability utilizing clinical trial management systems. Demonstrated experience using computers, specifically word processing, database, spreadsheet, and presentation applications such as Microsoft Word, Excel, Access, PowerPoint, or equivalent.

• Demonstrated experience in clinical research operations and budget preparation. Proven experience managing project budgets including monitoring expenses, creating and analyzing projections, auditing fiscal reports, and providing status reports.

• Working knowledge of medical and scientific terminology.

PREFERRED QUALIFICATIONS

• Knowledge of UC San Diego Medical Center clinical and ancillary services.

• Knowledge of patient education resources at UC San Diego Medical Center and in the community.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.

• Must be willing to work near labs and clinics where biological, chemical, and radiation hazards are present.

• Must be willing to work on projects where animals and human embryonic stem cells are used in research.

• Must be willing to enter labs and clinics for facilities and space responsibilities.
  Occasional travel required.

• Must be willing to work a flexible schedule based on business needs.