Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first and largest cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network (HVTN). Careers Start Here.
The HIV Vaccine Trials Network (HVTN) is the worlds largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.
SCOPE OF RESPONSIBILITIES The HIV Vaccine Trials Network (HVTN) is the worlds largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN 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 an effective HIV prevention vaccine.
The PDM manages the development of clinical trial protocols for HIV vaccines from concept to implementation, working with on-site and off-site protocol team members. The PDM establishes and maintains relationships, expectations, and collaborations, with team members with a wide range of expertise. The PDM may assist authors with the drafting and editing of concept sheets, concept proposals, and clinical protocols, including informed consent forms.
Direct development of clinical trial protocols for HIV vaccines and other investigational products from concept to implementation in conjunction with the Protocol Team Leader (PTL)
Establish and maintain relationships, expectations, and responsibilities with stakeholders with varying expertise and interests including, principal investigators, vaccine developers, statisticians, NIH DAIDS medical officers, laboratory staff, pharmacists, regulatory affairs staff, clinical staff, and community education staff
Manage development of documents and presentation materials for submission to funders, national regulatory entities, and other key audiences
Construct clinical development plans, including timelines, milestones, and key decision points
Contribute to the drafting and editing of protocols and related documents
Coordinate HVTN program initiatives encompassing multiple clinical trials, funders, and institutional stakeholders as requested
Organize and facilitate program stakeholder meetings
Drive protocol development timelines; establish team meeting agendas and track ensuing action items in coordination with PTL
Orchestrate submissions, reviews, responses to reviewer comments, and reviewer sign-offs of draft protocol documents from concept development through FDA submission
Organize and facilitate protocol team two-day face-to-face meetings
Support study conduct following implementation by collaborating with the data management and clinical trial Project Managers as needed
Assemble and process protocol modifications and amendments following implementation
Work on 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
Serve as a resource to colleagues within and outside of the US regarding protocol and protocol-related document development and control
Attend twice-yearly HVTN Meetings (out-of-state and out-of-country)
Minimum of PhD in immunology, biology, or related field is required
Knowledge of and experience with the conduct, research methods and regulatory 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 required
Demonstrated experience in managing multiple, deadline-driven complex projects simultaneously with minimal supervision required
Experience working with large teams in a global network with off-site collaborators preferred
High degree of organizational skills, effective time management, logical thinking, and close attention to detail
Extensive MS Word experience; MS Project, SharePoint, Tableau, and Visio highly desired
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.