HPV Standardization Initiative Project Manager

HPV Standardization Initiative Project Manager

Job ID: req3885
Employee Type: exempt full-time
Division: Vaccine, Immunity and Cancer
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines, other cancer preventive strategies and SARS-CoV-2 in the context of clinical and pre-clinical studies.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest. 

The HPV Serology Laboratory, at VICD is looking for an energetic HPV Standardization Initiative Project Manager for the HPV Serology Standardization Initiative. This initiative involves many international collaborators and studies with the overall aim of generating data that will contribute to implementation of HPV vaccination and elimination of HPV-associated cancers globally. The Project Manager will be responsible for testing and assay development activities, project management support, working directly with internal staff, government, and stakeholders to establish project goals, create work breakdown structures, milestones, deliverables, deadlines, budgets, reports, publications and subcontracts. This is an onsite position. No telework option.

Specific duties will include:

• Work closely with Scientific Manager, Directors, and collaborators to manage and provide project support for HPV initiatives.
• Work closely with Director, Administrative, and Finance on cost, budget, and finance for all program activities as needed.
• Provide scientific and administrative project management support, including drafting, revising technical responses, coordinating responses from internal teams to be included in Statements of Work, New Work Packages, and proposals.
• Monitor clinical study schedules, resources and performance, and assist with driving tasks to completion, making all necessary follow-up with stakeholders for timely responses.
• Generate and monitor all contractual deliverables and prepare any requested reports, ensure timely submissions.
• Organize and facilitate program meetings with internal and external stakeholders, including preparation of meeting materials and distribution, meeting minutes, manage action items, and other meeting logistics including scheduling and setting up appropriate meeting platforms.
• Manage subcontractors with financial tracking, progress reports, schedule, and assure project execution with established timelines.
• Serve as technical project manager and subject matter expert for subcontracts involving serology and immunology deliverables.
• Perform scientific review of subcontractor proposals, provide technical comments as well as recommendations, coordinate all comments for feedback distribution.
• Develop scientific protocols and Standard Operating Procedures, and other scientific documents for the laboratory as required.
• Support and manage laboratory projects including sample management, testing of samples, analyzing data under GCLP.
• Support optimizing and validating procedures and methodologies for assessment of immune response to infection and vaccines.
• In coordination with the VICD Administrative Team, collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, Material Transfer Agreements, Confidentiality Disclosure Agreements, other collaboration agreements, subcontracts, etc.
• Lead oral presentations and meetings with internal and external stakeholders.
• Develop and implement scientific proposals, write manuscripts, statistical analyses, as required.
• Maintain a knowledge of the most recent literature and scientific presentations relevant to projects.
• Perform other duties as assigned.

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a PhD in immunology, virology or a related biomedical field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of 0 to 2 years’ related biomedical laboratory and program/project management experience
• Expertise in tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, ELISA, Luminex assays, flow cytometry, virus neutralization assays and PCR.
• Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level.
• Strong scientific knowledge of vaccines, immunology, virology and serology.
• Experience with scientific technical writing and documentation.
• Must have exceptional communication skills with ability to communicate clearly with all levels of scientific personnel and administrative staff through written and oral presentations.
• Ability to multi-task and effectively prioritize and meet timelines in multiple concurrent projects.
• Ability to work independently in a dynamic environment and capable of completing tasks with minimal supervision.
• Scientific competency in a field relevant and related to cancer research.
• Must be able to obtain and maintain a security clearance

Candidates with these desired skills will be given preferential consideration:

• 8 years related biomedical laboratory experience 
• Project Management Professional (PMP) certification.
• Regulatory knowledge pertinent to standards GCLP, CLIA or FDA guidelines for clinical assays.
• Experience in immune assay (ELISA, multiple assays) development and validation under GCLP or GLP environment.
• Experience handling large data sets, statistics, software tools (Word, Excel, PowerPoint).
• Experience managing clinical immunological and vaccine studies and consortia activities.
• Experience working internationally in the areas of assay standardization.
• Experience with managing subcontracts, budgeting, cost estimates, and financial projections.

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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