Diagnostics Project Manager - HIV Vaccine Trials Network (HVTN)

Job ID
23497
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Project Management

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.


 

The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally. Our organization conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

 

HIV Diagnostics in the context of vaccine and antibody mediated prevention trials is complex and requires significant oversight and expertise. The HVTN employs four regional laboratories to perform the diagnostics for trials conducted in the U.S., Europe, Africa, and South America. These laboratories utilize the HVTN HIV Algorithm Workflow System (HAWS), which guides the laboratories through the diagnostics algorithms and creates reports for the clinics and independent adjudicators. All data from the HVTN diagnostic laboratories is uploaded to and analyzed by the HVTN Statistical Data Management Center (SDMC). Clinical reports are distributed via a secure web-based system and adjudicated by external reviewers. Diagnostic testing includes multiple different serologic tests as well as assays for HIV RNA and DNA to diagnose HIV infection and identify Vaccine Induced Seropositivity/Seroreactivity (VISP/R) in study participant specimens.

 

The Diagnostics Project Manager works as part of the HVTN Laboratory Operations team within the HVTN Laboratory Center and reports to the HVTN Director of Laboratory Operations. The incumbent will liaise directly with the Principal Investigators (PIs) and laboratory managers of the four regional HIV diagnostics laboratories for oversight of conduct of viral diagnostic testing, specimen management and data reporting. They will also assist clinical trial sites with questions related to specimen collection or results reporting, identify and manage CROs required for protocol operations, and advise internal and external groups in the regulatory requirements of diagnostic testing and the interpretation of diagnostic/genomic data.

Responsibilities

  • Collaborate with internal and external groups to establish laboratory operations to establish new or manage existing laboratory operations for conducting viral diagnostics and sequencing for HVTN protocols.
  • Monitor and evaluate diagnostic testing data to ensure laboratory operations meet CLIA, GCLP or other regulatory requirements, clinical need, protocol expectations and required turnaround times.
  • Provide subject matter expertise to clinical trial sponsors, protocol leadership, and SDMC regarding the implementation of laboratory operations and interpretation of diagnostic and genomic data obtained therein.
  • Communicate with clinical trial sponsors and protocol leadership concerning timelines and challenges regarding laboratory operations.
  • Develop standard operating procedures, lab study plans, and work practice guidelines for all processes related to testing algorithms, adjudication, data reporting and communications with clinical trial sites.
  • Review and update the HIV Diagnostics section of the HVTN Laboratory Center Manual of Operations.
  • Manage updates and version control of the HIV diagnostic algorithms employed for endpoint testing.
  • Manage updates and changes to the electronic software systems (i.e., HAWS or other LIMS) employed to manage diagnostic testing.
  • Oversee and track the endpoint adjudication process for efficacy trials, oversee updates to the electronic adjudication system, and communicate with endpoint adjudicators regarding outstanding or discrepant determinations.
  • Provide study updates and trainings to the HIV diagnostics laboratories and conduct onsite laboratory visits to receive updates and address any pending issues
  • Facilitate budgeting and contract discussions with laboratories and CROs.
  • Communicate with Laboratory PIs regarding equipment and staffing needs for HVTN trials
  • Manage analysis and distribution of end-of-study communications to site PIs and participants regarding VISP/R.
  • Facilitate post-study participant management plans for participants with vaccine-induced seroreactivity.
  • Maintain knowledge of advancements in diagnostic testing, genomic analysis, and GCLP standards.
  • Prepare and contribute to manuscripts and presentations at national and international conferences.

Qualifications

MINIMUM QUALIFICATIONS:

  • Master's degree in a related field. PhD in a scientific field or MD preferred
  • Minimum of 5 years related project/study management experience
  • Experience in HIV diagnostic testing.
  • Good communications skills and business acumen
  • Self-motivated, ability to work autonomously

PREFERRED QUALIFICATIONS:

  • Hands on experience in a CLIA/CAP certified clinical laboratory.
  • Laboratory management experience
  • Experience in TB and SARS-CoV-2 diagnostic testing.
  • Background in HIV virology and immunology.
     

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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