The Scientist (80% - full time) will participate in the development and writing of investigator-initiated clinical cancer immunotherapy trials and be the primary individual responsible for submission of these protocols (and their reports/renewals and related correspondence) to regulatory agencies (such as the US FDA). In addition, the Scientist will oversee the performance and analyses of ancillary biological studies to achieve the scientific aims of those clinical trials, analyze collected lab and clinical data and be a co-investigator/co-author for publications related to these clinical trials. The overall aim of the clinical immunotherapy research initiatives in the Division of Pediatric Hematology, Oncology, and Bone Marrow Transplant (The Division) is to improve outcomes for children with cancer and non-malignant hematologic diseases.
The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.
Protocol development/writing working closely with the PIs
IND/IDE application preparation and submission for the FDA
IND/IDE maintenance including amendments, safety reports, and annual reports
Preparation, submission and continuing reviews for IRB applications for biological studies on human specimens (e.g., tissue, cells)
IRB application and amendment preparation oversight and annual renewals for clinical studies and laboratory-based IRB approvals required for immune monitoring on samples obtained from human subjects participating in clinical trials
Preparation of PRS (Protocol Registration and Results System) documents for ClinicalTrials.gov
Ancillary Biological Study Kit preparation; scheduling and retrieval of patient research samples
Supervision of Clinical Trial Subject research specimen processing
Data Analysis of Clinical Trial ancillary biological studies
Data Analysis of Clinical Trial outcome measures
Preparation for internal/external compliance reviews (e.g., UW CCC, FDA)
Case Report Form development
Standard Operating Procedures preparation (for clinical trial ancillary biological studies)
Supervise research associate in the organization, conduct and record keeping of all immune monitoring results
Work with other scientists and research associates within the laboratory and clinical team on research aspects and clinical monitoring aspects to ensure compliance and laboratory regulatory requirements are adequate, current and practiced/maintained within the laboratory.
Work with other researchers and PIs in the Division to prepare data for publication and assist as co-author of publications regarding clinical trials
Function as a co-investigator on grant submission and conduct for grants related to clinical trials and analyses of lab specimens from clinical trials
Please apply by November 25th. Preferred start date in Madison is Jan. 1, 2021.
To apply for this position, please click on the "Apply Now" button in the Jobs at UW website:
You will be asked to upload a complete CV and cover letter as a part of the application process. Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position. You will also be asked to provide three professional/supervisor references during the application process.
Degree and area of specialization:
Doctoral degree (PhD, MD or DO) in biological or health science field; preferred expertise in immunology and/or cancer research
Preferred: Additional graduate degree (masters or PhD) in Clinical Investigation or equivalent program
Minimum number of years and type of relevant work experience:
3 years of post-doctoral laboratory and/or clinical trials experience is required
1 year of experience writing and maintaining clinical protocols and documents (such as INDs/IDEs for the FDA) or Regulatory Affairs Certificate (RAC) from RAPS.org (or equivalent certification or experience) is required
1 year of clinical trial protocol writing experience OR graduate degree in Clinical Investigation or ACRP Certification (CCRA, CCRC, CPI, ACRP-CP or ACRP-MDP) is required
Preferred: Experience in manuscript preparation, submission and presenting results at scientific meetings
Preferred: Experience with laboratory analyses of biological specimens via cell culture, flow cytometry, ELISA, in vitro cell function assays or equivalent
Additional Salary Information: Minimum salary of $43,362; higher salary per University of Wisconsin standards, based on qualifications and experience.
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About University of Wisconsin, Division of Pediatric Hematology-Oncology-BMT
The mission of the University of Wisconsin Pediatric Hematology, Oncology & Bone Marrow Transplant division is to provide innovative, comprehensive, and compassionate family centered clinical care to current and future patients at UW. Excellence in clinical care is dependent upon research and teaching, and requires their complete integration through all aspects of this program. Our vision is that excellence is best accomplished by a collection of interdisciplinary professionals, functioning as a team, with mutual respect and shared goals. The success of this team requires close interactions with supportive agencies and structures (i.e. local medical providers, hospitals, universities, government, third party payors, etc.), a unified strategy for progress, and a commitment to serving the public and community.