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Director of Clinical Research - 125560

UC San Diego Health

Job Description

UCSD Layoff from Career Appointment: Apply by 09/27/2023 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 10/06/2023. Eligible Special Selection clients should contact their Disability Counselor for assistance.

This position will remain open until a successful candidate has been identified.

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.

Reporting directly to the Executive Director, the Director of Clinical Operations 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 Operations 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, under the umbrella of the Sanford Stem Cell Institute, 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 Operations 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
  • Nine (9) years of related experience, education/training, OR an Bachelor's degree in related area plus five (5) years of related experience/training.

  • Experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Experience in training others in the field of research. Proven supervisory skills. Strong decision-making skills and ability to use independent judgement to quickly set priorities, solve problems and resolve conflict.

  • 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.

  • 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 directing, organizing, and prioritizing workload to meet required deadlines and department objectives.

  • 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 with design of clinical trial data collection forms for use in multi-center studies, and data collection and management including quality control measures.

  • Experience with evaluating the clinical study design and ability to identify necessary resources and procedures to carry out successful implementation of the clinical study. 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 managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Experience in training others in the field of research. Proven supervisory skills. Strong decision-making skills and ability to use independent judgement to quickly set priorities, solve problems and resolve conflict.

  • Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems. Ability to make independent decisions, analyze situations, solve problems, and initiate actions for effective program and project management. Strong analytical and critical thinking skills to identify problems and develop innovative solutions.

  • Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate. Ability to interact effectively with a diverse group of people through all levels of the organization.

  • 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. Experience using computers, specifically word processing, database, spreadsheet, and presentation applications such as Microsoft Word, Excel, Access, PowerPoint, or equivalent.

  • 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. Possess skills of tact, poise, diplomacy, confidentiality and flexibility. Ability to effectively lead and participate in discussions regarding procedures and goals of unit.

  • Demonstrated ability to respond effectively to unexpected events and crises. Experience in recognizing adverse events and reporting.

  • Working knowledge of medical and scientific terminology.

PREFERRED QUALIFICATIONS
  • Experience in Phase I clinical trials.
  • 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.

Pay Transparency Act

Annual Full Pay Range: $91,300 - $170,700 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $43.73 - $81.75

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).


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

 

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