Cell & Gene Therapy Specialist

Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biological Sciences or related field, or equivalent experience.
  • Three years of experience in FDA/IND clinical stem cell procurement, including clinical research.
  • Experience with cell culture in clinical or research laboratories.
  • Proven collaboration skills with medical and scientific investigators.
  • Advanced knowledge of clinical care policies, HIPAA, and human research guidelines.
  • Demonstrated project management and excellent communication skills.
  • Ability to prioritize in a high-volume clinical setting.

Responsibilities

  • Oversee compliance with clinical study protocols and operational aspects of trials.
  • Analyze clinical research data, providing recommendations with significant program impact.
  • Manage procedural aspects of novel cellular therapy products and FDA-approved devices.
  • Serve as subject-matter expert in quality stem cell therapies.
  • Liaise with community, industry sponsors, and professional groups to assess patient care effectiveness.
  • Develop presentations and train clinical research staff.
  • Execute outreach and executive communication initiatives.

Benefits

  • High-quality, low-cost medical plans for employees and families.
  • UC pays dental and vision insurance premiums.
  • Extensive leave benefits, including parental and family medical leave.
  • Paid holidays and accrued paid time off.
  • Continuing education allowances and reimbursement programs.
  • Access to free professional development resources.
  • On-site Employee Assistance Program for mental health services.
  • Public Service Loan Forgiveness qualifying employer for eligible roles.
Full Job Description
Under general direction of the ASCC Program Director and ASCC Clinical Operations Supervisor, the Clinical Research Analyst 4/Cell and Gene Therapy Specialist is a professional and technical leader that will oversee compliance with clinical study protocols, resolve operational aspects of clinical studies/trials, comply, and analyze clinical research data and make recommendations that have significant impact to the program at the California Institute for Regenerative Medicine (CIRM) UC Davis Alpha Stem Cell Clinic (ASCC). This position is responsible for all procedural aspects of a wide variety of novel cellular therapy products, out-of-spec FDA approved products, and devices used in the ASCC including but not limited to receipt, short-term storage, preparation, and transportation of novel products, each requiring special conditions. The individual serves as subject-matter expert in delivery of quality stem cell therapies to the Clinical and Translational Science Center (CTSC) clinic space located in the UCDH ASB Building, Operating Rooms, Vascular Center, Davis 8, and other UC Davis Health clinical settings. This position serves as a liaison with the community, industry sponsors, and professional groups to help determine the need, relevance, and effectiveness of Alpha Stem Cell Clinic patient care. Develops presentations and trains patient care staff.

Apply By Date: 7/24/2026 by 11:59pm

Minimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position
  • Required to hold a valid California driver's license, have a driving record that is in accordance with local policies/procedures, and/or enroll in the California Employer Pull Notice Program
  • Bachelor's degree in Biological Sciences or related field and/or equivalent experience/training.
  • Three (3) years of experience in the field of FDA/IND clinical stem cell procurement and potential stem cell therapies; including at least one (1) year experience in the area of clinical research concentration.
  • Experience with cell culture, clinical laboratory, or research laboratory.
  • Experience in collaboration with medical and scientific investigators.
  • Experience working with a broad range of professionals, paraprofessionals, the public, and patients.
  • Advanced experience and interaction with industry sponsored and investigator initiated Clinical Trials.
  • Demonstrated experience recognizing adverse events and reporting protocols.
  • Advanced experience collaborating with medical and scientific investigators.
  • Advanced knowledge of clinical care/nursing policies, HIPAA requirements, IRB compliance, JCAHO regulations and federal guidelines for human research procedures.
  • Proven ability to understand complex research protocols, including rationales for clinical/laboratory measurements and results; experience educating staff in the research process.
  • Demonstrated project management skills and setting performance standards.
  • Excellent written and verbal communication skills to deal courteously and effectively with a broad range of professionals, paraprofessionals, the public and patients.
  • Excellent organizational skills in order to rapidly prioritize activities and coordinate work in a high volume, dynamic, multiple demand clinic and hospital setting.

Preferred Qualifications
  • Demonstrated experience educating staff in the research process.
  • Experience with Phase One Clinical Trials.
  • Advanced experience and demonstrated ability to conduct study procedures as Patient Care Coordinator of complicated clinical trials.
  • Experience creating and analyzing projections and providing status reports for clinical research programs.
  • Strong knowledge of and skill in use of established protocols and ability to identify and help to establish new protocols as indicated.
  • Proven knowledge of common diagnostic tests, exams, procedures used in stem cell clinical trials including purpose, supplies and/or equipment needed, how to perform test, exam or procedure accurately, infection control mechanisms and accurate recording in medical chart.
  • Familiarity with surgical nursing, immuno-compromised patients, working with code teams, and ER procedures.
  • Demonstrated knowledge of the Patient Bill of Rights in order to effectively assist patients and assume an advocacy role.
  • Knowledge of patient education resources at UC Davis Medical Center and in the community.
  • Knowledge of UCD Medical Center clinical and ancillary services.
  • Demonstrates knowledge and understanding of current stem cell clinical trial issues.

Key Responsibilities
  • 85% - Program Development and Operations
  • 15% - Outreach and Executive Communication

Department Overview

The UC Davis Alpha Stem Cell Clinic specializes in early phase, first-in-human trials. The Alpha Stem Cell Clinic is devoted to accelerating the translation of all types of stem cell, cell and gene modification research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel stem cell, cell and gene therapy clinical trials and ancillary studies for a range of difficult diseases. The Alpha Stem Cell Clinic is a wide-ranging collaboration with unique contributions launched by CIRM through the Alpha Clinic and other grants.

POSITION INFORMATION
  • Salary or Pay Range: $ 8,286.25 - $ 15,513.75
  • Salary Frequency: Monthly
  • Salary Grade: 108
  • UC Job Title: CLIN RSCH ANL 4 RP
  • UC Job Code: 005236
  • Number of Positions: 1
  • Appointment Type: Staff: Career
  • Percentage of Time: 100 %
  • Shift (Work Schedule): Day , 8am-5pm
  • Location: UCD Inst for Regenerative Cure (HSP041)
  • Union Representation: RP - Research and Public Service Professionals
  • Benefits Eligible: Yes
  • This position is 100% on-site

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page .

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html
  • High quality and low-cost medical plans to choose from to fit your family's needs
  • UC pays for Dental and Vision insurance premiums for you and your family
  • Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
  • Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Access to free professional development courses and learning opportunities for personal and professional growth
  • WorkLife and Wellness programs and resources
  • On-site Employee Assistance Program including access to free mental health services
  • Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
  • Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
  • Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands
  • Standing - Frequent 3 to 6 Hours
  • Walking - Frequent 3 to 6 Hours
  • Sitting - Continuous 6 to 8+ Hours
  • Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
  • Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
  • Lifting/Carrying over 50 lbs - Occasional Up to 3 Hours
  • Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
  • Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours
  • Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours
  • Bending/Stooping - Occasional Up to 3 Hours
  • Squatting/Kneeling - Occasional Up to 3 Hours
  • Twisting - Occasional Up to 3 Hours
  • Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
  • Reaching overhead - Occasional Up to 3 Hours
  • Keyboard use/repetitive motion - Continuous 6 to 8+ Hours

Environmental Demands
  • Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours
  • Loud noise levels - Continuous 6 to 8+ Hours
  • Marked changes in humidity or temperature - Frequent 3 to 6 Hours
  • Microwave/Radiation - Occasional Up to 3 Hours
  • Operating motor vehicles and/or equipment - Frequent 3 to 6 Hours
  • Extreme Temperatures - Occasional Up to 3 Hours
  • Uneven Surfaces or Elevations - Frequent 3 to 6 Hours

Mental Demands
  • Sustained attention and concentration - Continuous 6 to 8+ Hours
  • Complex problem solving/reasoning - Frequent 3 to 6 Hours
  • Ability to organize & prioritize - Continuous 6 to 8+ Hours
  • Communication skills - Continuous 6 to 8+ Hours
  • Numerical skills - Occasional Up to 3 Hours
  • Constant Interaction - Frequent 3 to 6 Hours
  • Customer/Patient Contact - Continuous 6 to 8+ Hours
  • Multiple Concurrent Tasks - Occasional Up to 3 Hours

Work Environment

UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space.

Must be willing to work a flexible schedule based on business needs; position is subject to Medical Surveillance procedures and review in accordance with federal and state laws and regulations and University policy. Work independently, with emphasis on the ability to closely follow clinical policies and procedures. Must be able to meet HIPAA compliance upon hire.

Special Requirements - Please contact your recruiter with questions regarding which activities apply by position
  • This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment
  • This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks

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