Protocol Development Manager II, HVTN
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 Hutch’s 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 nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network (HVTN). Careers Start Here.
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.
SCOPE OF RESPONSIBILITIES
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 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.
Responsibilities
- 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)
Qualifications
- 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
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 escmail@fredhutch.org or by calling 206-667-4700.