Project Scientist - DBK
University of California, Los Angeles


Requisition Number: JPF04614
Recruitment Period
Open May 22nd, 2019 through Wednesday, Jun 19, 2019 at 11:59pm (Pacific Time)

Description

PROJECT SCIENTIST

The Project Scientist candidate will perform research on gene therapy for genetic diseases of blood, cells, with a specific focus on leading the research group performing clinical trials. The Project Scientist will be responsible for supervising SRAs 1-3, post-doctoral fellows, graduate students and undergraduate student researchers and for publishing manuscripts for scientific journals. This position requires a Ph.D. in Microbiology or the equivalent discipline, extensive knowledge of the clinical regulatory requirements of Good Clinical Practice (GCP), familiarity with principles of Good Manufacturing Practice (GMP) for the compliant performance of clinical trials of investigative cell and gene therapies and at least 5 years of experience in molecular biology, experimental hematology, and compliant performance of early phase clinical trials. The incumbent must have experience in writing scientific manuscripts and research protocols, SOPs and other documents. The Project Scientist position is a 12-month, non-Senate position.

Interested candidates should apply on-line by June 18, 2019 on this site:

https://recruit.apo.ucla.edu/JPF04614

Starting Date: July 1, 2019 or as soon as mutually agreeable.

Specific Responsibilities include:

Gene correction of hematopoietic stem cells (HSC) has the potential to provide more effective and safe approaches to the treatment of genetic diseases of blood cells, to engineer the immune system to be resistant to HIV-1, and to direct immune effector cells against cancer and leukemia. Substantial progress has been made over the past 30 years, although the ability to efficiently modify HSC by adding genes with vectors or editing genes remains sub-optimal. New approaches that may be more effective include the use of alternative viral vectors (e.g. lentiviral and foamy virus-derived), the use of non-viral gene transfer methods (e.g. transposons or other integrating systems) or the development of methods for genome editing utilizing endogenous pathways of DNA repair for homologous recombination. These new approaches can be evaluated in pre-clinical cell culture and animal models, but ultimately must be assessed in well-designed and carefully performed clinical trials.

The Project Scientist will be responsible for leading these pre-clinical and clinical trial investigations in an independent manner. Extensive knowledge of the proper conduct of clinical trials using investigational reagents under Federal, State and University guidelines is mandatory. Additionally, a strong knowledge-base in molecular biology, gene expression regulation, stem cell biology and the according experimental methods is required for this effort. A major focus of the research of this Project Scientist will be to lead the development of new protocols for clinical trials, the submission of these protocols to the multiple regulatory entities that oversee these trials, and for overseeing the data management, documentation and regulatory reporting that is required. Also, development and implementation of a Quality Control Program for the GMP cell processing and analytic labs will be an important activity.

The specific objectives of the project are:

1. Develop the necessary clinical trial protocols, informed consent and other essential documents for clinical trials, development of essential case report forms and data monitoring plans.
2. Oversee operations in the HGCTF of the cell processing and analytic personnel to ensure full compliance with cGMP regulations.
3. Apply to all governing regulatory agencies and boards for approval for the trials.
4. Implement the trials, including overseeing patient enrollment, eligibility assessment, stem cell processing and preparation.
5. Performance of necessary documentation and reporting.

Additional Duties:

Supervision of Staff Research Associates I-III, undergraduates and graduate students and new postdoctoral trainees in the lab.

Ability to work on multiple projects efficiently and effectively.

Ability to work independently on scientific projects.

Assist with preparation of grant proposals, as needed.

Preparation of manuscripts for publication into scientific journals.

Required to communicate well with other scientists, regulatory personnel, biotech companies, Sponsored Research Organization, personnel worldwide.

Candidate should have at least 5 years research experience in molecular biology in an academic setting or equivalent as well as extensive knowledge of the principles of Good Clinical practice and the compliance issues that govern clinical trials using experimental reagents.

Should have extensive experience in cell culture and all types of cell biology and molecular biology, immunofluorescence/flow cytometry and biochemical techniques.

Unique and specialized knowledge and skills are required to work with human hematopoietic stem cells that includes but is not limited to HSC cell culture, isolation of nucleic acids and proteins, packaging and characterization of gene transfer vectors, and application of appropriate analytic methods (e.g. flow cytometry, PCR).

The candidate will report directly to the Principal Investigator.

Ability to make substantial contributions to the design of trials will be required to handle several different projects at one time. The candidate will also provide support in publishing the results of various projects.

The candidate will share responsibility in the general management and supervision of personnel in the laboratory.

The candidate will be responsible for ensuring that all laboratory equipment in working order and maintained per Quality Management plan.

Ongoing maintenance of necessary licensure, certifications and continual education are essential.

The position will require expertise in development and performance of clinical trials of gene transfer and expression studies with human HSC.

The candidate will be required to complete all appropriate safety training as mandated by the campus's Environmental Health & Safety Office.

The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy see: UC Nondiscrimination and Affirmative Action Policy.

http://policy.ucop.edu/doc/4000376/NondiscrimAffirmAct

University policy is intended to be consistent with the provisions of applicable State and Federal laws.

The Department is Particularly interested in candidates who have experience working with students from a diverse background and a demonstrated commitment to improving access to higher education for disadvantaged students or The (School) at UCLA is committed to building a more diverse faculty, staff and student body as it responds to the changing population and education needs of California and the nation.



To apply, please visit: https://recruit.apo.ucla.edu/JPF04614


The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy, see: UC Nondiscrimination & Affirmative Action Policy, https://policy.ucop.edu/doc/4000376/DiscHarassAffirmAction


jeid-0f64608a47c3a4439ecfb774b8f4df6d