Protocol Development Manager II

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Join us and make a difference!

The HIV Vaccine Trials Network (HVTN) is the world's 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. 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.

Responsibilities
- Direct development of clinical trial protocols for HIV vaccines from concept to implementation in conjunction with the Protocol Team Leader.
- Establish and maintain relationships, expectations, and responsibilitieswith 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.
- Organize and facilitate program stakeholder meetings.
- Drive protocol development timelines; establish team meeting agendas and track ensuing action items.
- Orchestrate submissions, reviews, responses to reviewer comments, and reviewer sign-offs of draft protocol documents 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 and
- 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).

Basic Qualifications:
- Master's degree in Biology or relalted field
- Knowledge of or experience with research methods and regulatory aspects of clinical trials

Preferred qualifications:
- Advanced proficiany with Microsoft Word, Project and Visio
- 3 or more years of clinical trial experience
- Experience working in a global network with off-site collaborators
- Ability to manage simultanious projects in different stages
- BS or Master's degree in Biochemistry or Public Health
- Previous Management experience

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2283879-2647-6721

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