Lynette N.

Lynette N. Email and Phone Number

Rockville, MD, US
Lynette N.'s Location
Rockville, Maryland, United States, United States
Lynette N.'s Contact Details

Lynette N. work email

Lynette N. personal email

n/a
About Lynette N.

Accomplished program manager with a Ph.D. focused in neurobiology, specializing in biomedical and translational research operations with more than twenty years’ experience working as a laboratory scientist, standing up new biomedical initiatives, and managing scientific and clinical programs, including multimillion dollar budgets. Extensive experience in contract negotiation, stakeholder engagement, business analytics, and capacity building. Experience in biotechnology R&D, cancer, metabolic-cardiovascular, and infectious disease areas.

Lynette N.'s Current Company Details
Alaka`ina Foundation Family of Companies

Alaka`Ina Foundation Family Of Companies

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Program Manager
Rockville, MD, US
Lynette N. Work Experience Details
  • Alaka`Ina Foundation Family Of Companies
    Program Manager
    Alaka`Ina Foundation Family Of Companies
    Rockville, Md, Us
  • Vlp Therapeutics
    Program Manager
    Vlp Therapeutics Sep 2023 - Present
    Gaithersburg, Maryland, United States
    Managed cancer immunotherapy and vaccine R&D programs using patented and novel platforms, working with R&D Teams: - Provided oversights on preclinical studies that support innovative vaccine development for dengue, influenza, and covid.- Provided oversights on research and preclinical studies, process development, and good manufacturing practices on candidate cancer drugs- Supported clinical study designs for phase 1 clinical trials. - Served as liaison to senior management: the Food and Drug Agency (FDA), National Institute of Health (NIH), the Walter Reed Army Institute of Research (WRAIR), clinical/contract research organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), academic institutions, and collaborators. - Negotiated contracts and interfaced with senior management to ensure timely initiation and closure of projects, timely delivery on commitments, and budget/resource alignment.- Planned annual budget and program resources.
  • Foundation For The National Institutes Of Health
    Senior Scientific Project Manager, Metabolic Disorders
    Foundation For The National Institutes Of Health Jan 2022 - Jun 2023
    North Bethesda, Maryland, United States
    The FNIH brings together public health agencies and private organizations, academic institutions, and patient advocacy groups to advance science and solve complex medical issues. - Managed the Accelerating Medicines Partnership (AMP) program in Common Metabolic Diseases (AMP CMD), a $47M+ public-private partnership comprised of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institute of Health (NIH), and pharmaceutical companies to provide researchers worldwide with open access to genetic, genomic, proteomics, transcriptomics, metabolomics data. Developed request for proposal, created a review process, advised on grant administration process; negotiated contracts with institutions and vendors; developed scopes, timelines, milestones, and deliverables with investigators; managed budget and forecasting. - Managed the design/stand-up of the AMP Amyotrophic Lateral Sclerosis initiative with the National Institutes of Neurological Disorders and Stroke (NINDS, NIH), the FDA, and patient advocacy groups to accelerate research on early diagnostics and treatments. - Developed and managed the 2022 stand-up of AMP Heart Failure, a $37M initiative with the leaderships of the National Heart, Lung and Blood Institute (NHLBI, NIH), the FDA, and pharmaceutical companies to identify gaps in HFpEF research, receiving the 2022 NIH Director’s Award for exceptional performance and the 2023 NHLBI Director’s Award in Partnership/Collaboration.
  • Foundation For The National Institutes Of Health
    Scientific Project Manager, Metabolic Disorders
    Foundation For The National Institutes Of Health Apr 2020 - Dec 2021
    North Bethesda, Maryland, United States
    - Planned, developed, co-authored proposal, and launched the AMP CMD. - Managed closure of the AMP Type 2 Diabetes, a seven-year, $52M public-private partnership composed of NIDDK, NIH, non-profit organizations, and pharmaceutical companies. The project met and exceeded all goals and closed under budget.- Led the Education subcommittee of the Diversity, Equity, Inclusion, and Accessibility Committee.
  • Iqvia
    Project Manager
    Iqvia Oct 2019 - Apr 2020
    Managed the transition from paper Informed Consent to eConsent for all globally-participating sites in clinical trials and maintained the eConsent process throughout the lifecycle of the trials. Coordinated with site principal investigators and clinical project managers on study initiation activities, IRB approval statuses, issue mitigation, and change orders. Managed contracts, budget, and forecasting.
  • United States Pharmacopeial Convention
    Ec Manager - Small Molecules & Food Ingredients
    United States Pharmacopeial Convention Mar 2013 - Jun 2019
    Rockville, Md
    Managed compendial work of Small Molecules, Food Ingredients Expert Committees, Expert Panels, and Working Groups. Working with the FDA and pharmaceutical companies, prepared quarterly ballots for the Expert Committees to vote on new, revised or modernized reference standards. Managed thousands of reference standards workflows to ensure readiness from ballot to official status. Liaised with reference scientists to coordinate the supply chain. Negotiated terms for confidential disclosure agreements with pharmaceutical companies and the FDA. - Managed the Over-the-Counter (OTC) Drug Products Working Group composed of manufacturers, Consumer Healthcare Products Association Members, the FDA, and USP Expert Volunteers with the objective of delivering OTC public standards for complex formulations. Managed Acetaminophen Expert Panels to determine the organic impurities safety limits.- Received award for project initiative, data analysis and findings of the root cause for the large number of monograph deferrals which produced key deliverables to form Critical-Resources-Information-Sharing-Priorities, a key initiative at USP, and evangelized the FDA to share critical information. - Hosted international delegations at workshops on drug impurities and herbal medicines, interpreting for Vietnamese delegates from the National Institute of Drug Quality Control. Drafted country work plans.
  • Blind Babies Foundation
    Board Member, Interim Vice President
    Blind Babies Foundation Sep 2003 - May 2008
    San Francisco, California, United States
    Through community outreach and education, expanded programs that served babies and children with vision impairments who did not qualify for state assistance. Established governance, oversaw programs, and managed risks. Spearheaded fundraising activities. Served as interim Board Vice President from 2007-2008. - Recipient of the Person of the Year award (2008)
  • The Smith Kettlewell Eye Research Institute
    Post-Doctoral Fellow
    The Smith Kettlewell Eye Research Institute Oct 1996 - Dec 2000
    San Francisco, California
    Independently developed, planned, and implemented research on visual neural networks and quantified early neurotransmitter release in the developing retinas of mammals and amphibians. Applied enzyme-linked immunosorbent assay, immunohistochemistry methodologies, high-performance liquid chromatography, light and electron microscopy to research. Contributed to grant proposals on strabismus that received funding from the National Eye Institute, NIH. Presented at scientific conventions and published abstracts and papers.
  • Biometric Research Insititute
    Clinical Research Assistant
    Biometric Research Insititute Jun 1990 - Aug 1991
    Arlington, Virginia, United States
    Interfaced with site staff to monitor clinical trials in phases 3 and 4 for a large Pharma to evaluate drug effectiveness and safety. Assisted in drafting of reports.

Lynette N. Education Details

Frequently Asked Questions about Lynette N.

What company does Lynette N. work for?

Lynette N. works for Alaka`ina Foundation Family Of Companies

What is Lynette N.'s role at the current company?

Lynette N.'s current role is Program Manager.

What is Lynette N.'s email address?

Lynette N.'s email address is ln****@****nih.org

What schools did Lynette N. attend?

Lynette N. attended University Of Virginia, Medical College Of Virginia.

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