Poseida Therapeutics, Inc. is seeking a talented Clinical Scientist to join our team in San Diego, CA. This position offers an excellent opportunity for a highly motivated individual to help support and contribute to the development of clinical strategy for a growing biotech developing new CAR-T cell, gene editing and gene therapy products. Primarily, the role will be responsible for providing scientific and strategic support of our clinical programs. We are seeking a well-trained scientist/clinician who is driven by science and the desire to develop novel therapies for cancer and orphan disease patients.
These may include but are not limited to:
- In collaboration with the project physician, perform regular data review of individual and aggregate subject data and monitor compliance and data quality including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, study endpoints, protocol deviations and laboratory parameters
- Partner with Data Management, Biostatistics, and the program medical lead for CRF design, CRF completion guidelines, data review plan, medical review plan and data listing design
- In conjunction with Biostatistics and the project physician create study level and program level analysis plans
- Contribute to the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
- Author or contribute to the scientific writing for documents in whole or in part including protocols and amendments, clinical study reports, investigator’s brochure, regulatory documents including briefing books and DSUR, meeting abstracts and scientific publications
- Conduct searches and review of the scientific literature, and stay current on therapeutic area practice standards and guidelines
- Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Provide clinical research expertise to best collaborate with the clinical research physicians in managing ongoing projects.
- Assist in establishing project budgets and Standard Operating Procedures, and reviewing ongoing study data including safety, primary efficacy variables, and laboratory data
- Plan, participate and present at investigator meetings and ad-hoc meetings
- Prepare DMC and/or adjudication charters.
- Prepare deliverables for periodic review meetings and participate, e.g. Study Management Team
- Participate in and assist with advisory/scientific boards
- Prepare and present clinical data at external scientific/board meetings as needed
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Identify and work with Clinical Data Management resources to confirm data acquisition and aid in interpretation of analyses
- Support clinical study operation, including site selection, vendor management, investigator meetings, internal and external collaborations, etc.
- Provide strategic scientific input for future clinical data generation
- Assure quality data collection and generation
- Conduct regular review of listings
- Collaborate and support operational objectives as needed
- Other duties as applicable
Requirements, Knowledge, Skills and Abilities
- Advanced degree (M.D., Ph.D., Pharm.D., M.S.N., M.P.H.) in immunology, cancer biology or a closely-related field and at least 4 years of industry experience.
- Familiarity in the areas of cellular based therapy, molecular biology, immunology, immuno-oncology and /or cancer biology drug development (experience with CAR-T cell or gene therapy products is highly desirable).
- Familiarity with relevant biomarker technologies with e.g. flow cytometry, immunoassays , polymerase chain reaction, and immunohistochemistry, clinical sample testing, assay development.
- Understanding of regulatory requirements related to the clinical studies and compliance.
- Understanding of basic CAR-T cell and gene therapy biology
- Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
- Strong organizational and record-keeping skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment and able to adapt to changing priorities
- Microsoft office (Word, Excel, and PowerPoint) skills are required
- Self-motivated and ambitious candidate with a strong work ethic
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.