Program Director, Center of Excellence for Serology Development and Emergency Preparedness (CESDEP) in Frederick, MD
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 Center of Excellence for Serology Development and Emergency Preparedness (CESDEP) is a new program to provide both a more targeted and global response to the evolution of SARS-CoV-2, requiring innovative thinking, outreach and partnership with global leaders. CESDEP will leverage and deploy the knowledge from SeroNet to bring high quality, precision biomarker assays to the cancer and HIV clinics to help combat SARS-CoV-2 in those most vulnerable.
The Program Director for CESDEP's will establish and manage the CESDEP program, including development of a flexible network and infrastructure to support the evolving need to collect serum and plasma in large volumes to support standard and validation platform development. This program will also support the study enrollment of healthy, HIV and cancer patients in longitudinal studies for the purpose of procuring plasma, serum, clinical, serological and other immunological data. This work will be conducted by working closely with academic medical centers and other commercial partners. The Director's responsibility is to clarify and operationalize programmatic goals to ensure success of the project. Novel assays will be developed in partnership with others and will require platform cross-validation. Goal is to bring clinically validated serology-based biomarker assays to the clinic to address gaps in vaccination protocols inherent in immunosuppressed patients, in particular HIV and cancer community for SARS-CoV-2.
It is the director's responsibility to implement this novel program which requires partner outreach, oversight of biospecimen procurement, sample and testing management activities, data management and associated logistics. Existing biospecimen infrastructure will be leveraged and optimized. Ability to work with multiple function areas is a must, including quality, IT team, and other scientists and lab managers. A lab is being established at the FNLCR where baseline serology measurements will be established, and panels and standards developed. You will work closely with the CESDEP lab manager. External testing sites will be established, for the purpose of “cross” validation of assays, as well as for the purpose of novel biomarker assay development role, the director will work closely with the CESDEP laboratory manager so that samples are tested, assays developed, and the highest standard of excellence maintained.
- 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, NIBSC, CDC, BARDA industry, foundations, and the U.S. government.
- Work directly with the stakeholders and Program Directors to develop scientific vision, clarify program goals and requirements and identify gaps in the evolving pandemic field.
- Communicate scientific requirements to the operations team for program execution.
- Operationalize requirements in the context of the existing infrastructure and best practices for biospecimen and data management.
- Report to the VICD Director of Resources and Data Management.
- Manage small team of Scientific Project managers to provide technical direction to subcontractors to meet specimen and testing deliverables, deadlines, and milestones.
- Ensure project execution within established timelines and approves subcontractor invoices.
- Lead and develop meeting activities within the program to ensure agendas, meeting formats, and logistics are clear for VICD meeting support staff.
- 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.
- Contribute to the Development of Standard Operating Procedures and Best Practices for Serology and other biomarker research.
- Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, collaboration agreements, subcontracts.
- Report research data, including presentations and/or scientific publications.
- Maintain knowledge of the most recent literature and scientific presentations relevant to projects.
- Perform other duties as needed to ensure the success of the program.
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of MS 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, project and data management.
- Minimum of four (4) years of management experience.
- Experience with biospecimen and clinical data collection projects and infrastructure.
- 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:
- Possession of PhD degree.
- 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.
- In-depth understanding of immunology, immune assays, diagnostics, vaccines, and clinical research.
- Excellent communications skills (written and oral).
- Experience with data management.
- Ability to work effectively in a matrix and team-oriented environment.
- Ability to identify and solve complex problems.
- Strong organization and multitasking skills.
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
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