Protocol Development Manager, HVTN

Job ID
23072
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
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 for 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 the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines and antibodies to prevent HIV/AIDS. Most recently, the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease. The HVTN has also expanded the scope of preventative infectious disease work to include the intersecting pandemic of TB by working with collaborators to evaluate novel TB vaccine approaches.

 

The HVTN/CoVPN conducts all phases of clinical trials, from evaluating experimental vaccines and other study products for safety and immunogenicity, to testing vaccine efficacy. The Protocol Development Manager (PDM) position provides a unique opportunity to work with leading world-class scientists and collaborators around the world and join the global team in discovering effective HIV, COVID-19, TB and other preventative vaccines and antibodies.

 

The PDM II manages the development of clinical trial protocols for HIV, COVID-19, TB and other vaccines and antibodies from concept to implementation, working with on-site and off-site protocol team members. The PDM II establishes and maintains relationships, expectations, timelines, and collaborations, with team members with a wide range of expertise. The PDM II may assist authors with the drafting and editing of concept sheets, concept proposals, and clinical protocols, including informed consent forms. The PDM II utilizes project management, interpersonal communication, and critical thinking skills to direct the protocol development process.

Responsibilities

  • Project manage, co-write, and direct development of clinical trial protocols for HIV, COVID-19, TB and other vaccines and investigational products from concept to implementation in conjunction with the Protocol Team Leader (PTL).
  • Establish and maintain relationships, expectations, and responsibilities with key opinion leaders/stakeholders with varying expertise and interests including the external partners of: principal investigators, vaccine developers, NIH/NIAID/DAIDS sponsor representatives (medical officers, project officers, pharmacists, and Regulatory associates), and other sponsors and/or funder representatives; as well as HVTN internal partners: laboratory staff, statistical and data management staff, regulatory affairs staff, trial operations and clinical staff, and community education staff.
  • Manage development of eCTD compliant documents and presentation materials for submission to sponsors, funders, national regulatory entities, and other key audiences.
  • Construct clinical development plans, including timelines, milestones, and key decision points.
  • Medical writing: coordinate, co-author and manage the development of drafting and editing of protocols, informed consents, and related documents. Manages all aspects of the clinical protocol development process.
  • Coordinate HVTN/CoVPN program initiatives encompassing multiple clinical trials, funders, and institutional stakeholders as requested.
  • Organize and facilitate program stakeholder meetings and protocol team meetings, which may include multi-day face-to-face meetings.
  • Drive protocol development and project timelines; establish team meeting agendas and track ensuing action items in coordination with PTL.
  • Orchestrate submissions, reviews, responses to reviewer comments, and reviewer signoffs of draft protocol documents from concept development through FDA submission.
  • Support study conduct following implementation by serving as a resource for the data management staff and clinical trial Project Managers as needed.
  • Assemble and process protocol modifications and amendments following implementation when required.
  • Manage special projects that may include:
    • Scientific writing, literature and data reviews, and grant and manuscript development support.
    • Compiling data and creating protocol and clinical development slides.
    • Cross-protocol continuous process-improvement activities.
    • Assist in the development of new or improvement of existing cross-unit processes as required.
    • Other project management duties as needed.
  • Provide mentorship and training for newer PDMs.
  • Serve as a resource to colleagues within and outside of the US regarding protocol and protocol-related document development, submissions, and control.
  • Attend twice-yearly HVTN/CoVPN Meetings (out-of-state and out-of-country) when travel restrictions are not in place.

Qualifications

  • PhD in immunology, biology, or related field, with two years of clinical trial research experience; or Masters in immunology, biology or related field with four years of clinical trial research experience required.
  • Knowledge of and experience with ICH guidelines, GCP, and the conduct, research methods and regulatory submissions and aspects of clinical trials.
  • Excellent writing skills and scientific vocabulary capable of effective verbal and written communication with clinical research staff, health professionals, and clinical scientists.
  • Scientific project management experience preferred.
  • Demonstrated experience in managing multiple, deadline-driven complex projects simultaneously with minimal supervision.
  • High degree of organizational skills, effective time management, logical thinking, and close attention to detail.
  • Extensive MS Word experience required.
  • Ability to work cross-functionally in a global network with off-site collaborators preferred.
  • Experience with SharePoint, Microsoft Teams, and a project management software tool are highly desired.

 

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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