Poseida Therapeutics, is seeking a talented Clinical Scientist to join our team. 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 project medical director/clinical lead in for the creation of CRFs, CRF completion guidelines, data review plan, medical review plan and data listings
· Contribute to the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and collaborate with data management and clinical operations in the management of issues with 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
· Assist in establishing project budgets and Standard Operating Procedures, and reviewing ongoing study data including safety, primary efficacy variables, and laboratory data
· Prepare DMC charters.
· Prepare deliverables for periodic review meetings and participate in Study Management Team meetings
· Participate in and assist in the planning of scientific advisory boards; plan, participate and present at investigator meetings and ad-hoc meetings
· Prepare and present clinical data at internal and external scientific advisory board meetings as needed
· Strong understanding of Good Clinical Practices, pharmacovigilance standards, and all other quality standards in conducting research.
· Collaborate with the project physician and the biostatistician in the interpretation of data and the creation of analysis plans
· Support clinical study execution, including participating in site selection, vendor management, investigator meetings, internal and external collaborations as needed
· Participate in the creation of clinical development plans with the project physician including the provision of strategic scientific input
· Collaborate with data management and clinical operations to ensure the appropriate collection and cleaning of clinical data
· Conduct regular review of listings
· 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 (a combination of education and experience may be considered).
· 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
Apply at: https://recruiting.paylocity.com/recruiting/jobs/Apply/321689/Poseida-Therapeutics-Inc/Clinical-Scientist