Program Director, CESDEP
Job ID: req3006
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.
The Vaccine, Immunity and Cancer Directorate
investigates immune responses to vaccines in preclinical and clinical studies,
with a focus on HPV and more recently on SARS-CoV-2. As part of a large effort
to combat the current SARS-CoV-2 pandemic, the National Cancer Institute (NCI)
is collaborating with the National Institute of Allergy and Infectious Disease
(NIAID), the Centers for Diseases Control and Prevention (CDC), the Food and
Drug Administration (FDA), the Frederick National Laboratory (FNL) and other
stakeholders to develop assays with the highest reproducibility, sensitivity,
and specificity for evaluation of immune responses against this new
virus. To address gaps and unmet needs in serology assay development and
standardization and to gain a solid fundamental knowledge of the immune
response to SARS-CoV-2 and underlying mechanisms of protection against
infection, NCI has established the Serological Sciences Network (SeroNet),
which includes the Frederick National Laboratory (FNL) Serology Lab, leveraging
the vast expertise and excellence in HPV serology at the FNL.
The Project Director of CESDEP’s core functions are to establish and
manage the operations of the CESDEP program including administrative and
logistic aspects associated with resource management pertaining to samples,
data, standard operating procedures, standards and assay development, oversight,
development, management of subcontracts and services with centers of excellence
for biospecimen collection sites and testing sites, and the development and
operation of a data infrastructure to support storage, coordination, in network
data sharing and public dissemination.
Specific duties of the Project Director, CESDEP will
- Work directly with the stakeholders and Program scientific managers and directors to identify needs and establish priorities for the program.
- Establish infrastructure and best practices for biospecimen and data management.
- Direct and provide oversight of the biospecimen and data management activities for the Program.
- Network, build, and lead consortium efforts consisting of stakeholders, centers of excellence in serology testing and biospecimen collection, and other organizations such as academia, FDA, WHO, CDC, institutions, foundations, and the U.S. government.
- Oversight of subcontractors to meet the deliverables, deadlines, and milestones.
- Initiate new subcontract packages or other similar mechanisms, including statements of work for subcontracts for new Work Packages.
- Manage subcontracts and ensures project execution within established timelines and approves subcontractor invoices.
- Oversight and lead meeting activities within the program including facilitating, organizing, setting up meeting logistics (meeting platform, recording, minutes, agenda, speakers, materials, distribution).
- Lead and organize appropriate and relevant scientific meetings to facilitate discussions on emerging topics with stakeholders, external agencies, academia, commercial entities.
- Monitor project progress, schedules, risks and budgets, plan and anticipate programmatic changes, prepare detailed action plans, and execute implementation plans in leading the program.
- Participate in scientific discussions to determine the direction of the program.
- Prepare technical responses to task orders and establish deliverables, timelines.
- Develop Standard Operating Procedures.
- Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, collaboration agreements, subcontracts.
- Report research data, including presentations and/or scientific publications.
- Conduct statistical analyses.
- Maintain knowledge of the most recent literature and scientific presentations relevant to projects.
- Perform other duties as necessary and assigned.
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of masters degree in immunology, virology or a related biomedical field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or six (6) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of eight (8) years of related experience managing research, experimental planning, proposal writing and project management.
- Minimum of four to six (4-6) year of management experience.
- Experience with scientific technical writing and documentation.
- Experience budgeting, cost estimates, and financial projections.
- Experience interpreting and/or authorizing Statement of Work (SOW).
- Experience leading scientific networks and dealing with public and private partners.
- 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 or related to cancer research.
- Ability to obtain and maintain a security clearance.
Candidates with these desired skills will be given preferential consideration:
- Possesson of PhD.
- Project Management Professional (PMP) certification is a plus.
- Serology, immunology and standards knowledge.
- Regulatory knowledge pertinent to standards GCLP, CLIA, FDA guidelines for clinical assays.
- Familiarity with biospecimen processing best practices, and diagnostic assay development and validation.
- Experience organizing Investigators Meetings and/or scientific workshops is a must.
- Familiarity with diagnostics and clinical trials.
- This position is subject to working with or have potential for exposure to infectious material, requiring
medical clearance and immunizations.
- In-depth understanding of immunology, immune assays, diagnostics, vaccines and clinical research.
- Excellent communications skills (written and oral).
- Ability to work effectively in a matrix and team-oriented environment.
- Ability to identify and solve complex problems.
- Strong organization and multitasking skills.
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)