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Manager Program

Raleigh, North Carolina, 27606, United States
February 21, 2018

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PROJECT MANAGER WITH RESEARCH AND DEVELOPMENT EXPERIENCE Focused and experienced Project Manager with experience working with complex, high profile projects. Talented in identifying, framing, and solving complex problems with expert analytical abilities. Key team player with excellent interpersonal and communication skills, establishing and maintaining strong relationships with clients, colleagues and service providers. Experienced in managing timelines, multimillion dollar budgets, client expectations, and project development/implementation. Strong technical immunology, virology, and cell culture skills with experience in bioassay development. Expertise includes:

Clinical Trial Development

Financial Management

Technical Writing & Regulatory


Building and Maintaining Client/Vendor


Audit Preparedness

Risk Identification and Mitigation

Vaccine R&D

Organization & Time Management

ICH, GCP, GMP guideline familiarity


Syneos HealthTM (formerly inVentiv Health Consulting) April 2017 – Present Associate Program Manager III

Facilitate the tactical implementation and life cycle maintenance of single shared Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) programs within the Program Management Office division. Identify potential project and implementation risks and dependencies. Assist in the management of complex budgets, including budgets with over $4,000,000 in direct revenue. Maintained workstreams associated with APM I and II roles and in addition:

Onboard and oversee professional development junior staff

Identify process improvements for financial management across the Program Management Office

Plan and implement the integration of 30+ additional clients into the shared program

Assist in the development of proposals to win new work

Manage client relationships to ensure client satisfaction and win new work

Facilitate development of deliverables across internal teams, including finance, contracting, and consulting inVentiv Health Consulting April 2016 – April 2017 Associate Program Manager II

Facilitate the tactical implementation and life cycle maintenance of single shared REMS programs within the Program Management Office division. Maintained workstreams associated with APM I role and in addition:

Increase direct revenue by $500,000 through identification of additional project scope

Analyzed risks and benefits associated with changing program needs as a result of regulatory program updates

Assisted clients with the negotiation of inter-client agreements to meet and exceed FDA deadlines inVentiv Health Consulting April 2015 – April 2016 Associate Program Manager I

Facilitate the tactical implementation and life cycle maintenance of single shared REMS programs within the Program Management Office division.

Assist clients with the review, approval, and oversight of industry-sponsored grants

Maintain and update regulatory documentation for client review, approval, and FDA submission

Supervise vendors on behalf of clients, including participation in contract negotiation and management

Actively support clients and act in an outward-facing role in meetings with the FDA

Assemble, analyze, and report on data obtained from external vendors and partner organizations

Analyze processes and procedures and refine as necessary to increase efficiency and reduce client costs Arbovax, Inc January 2012-April 2015

Research Scientist

Lead research and development efforts of two live attenuated viral vaccine candidates from bench through Phase I clinical trials.

Oversee efforts of two technicians, cell culture and virology laboratories.

Serve as point of contact for CMO and CRO

Manage tech transfer and SOP development.

Author regulatory documentation, scientific journal articles, and progress reports as needed.

Identify a method to grow vaccine candidates in FDA-approved insect cell line, saving company over $250k in vaccine manufacturing costs

Maintained and developed mammalian and insect cell lines for vaccine manufacture in both adherent and suspension phases

Authored two pre-IND regulatory submission to FDA and designed corresponding Phase I clinical trials o Served as company representative to FDA for regulatory meetings

Develop immunoassays such as ELISAs to measure vaccine efficacy o Engineered assays in light of market gap for both murine and primate models of infection EDUCATION AND TRAINING

Doctor of Philosophy, Microbiology and Immunology (2011); Wake Forest University – Winston-Salem, NC Bachelors of Science, Biology with General Education Honors (2006); East Carolina University- Greenville, NC TECHNICAL PROFICIENCIES

MS Office (Outlook, Word, Excel, Power Point)

Teleconference tools (WebEx, Concur, Skype)


Briggs CM, Smith KM, Spears CJ, Quiles M, Huitt E, Piper A, Riberio M, Thomas ME, Brown DT, and Hernandez R. 2014. Live Attenuated Tetravalent Dengue Virus Host Range Vaccine is Immunogenic in African Green Monkeys following a Single Vaccination. J. Virol 88(12)6729-42 Piper A, Riberio M, Smith KM, Briggs CM, Huitt E, Spears CJ, Quiles M, Thomas ME, Brown DT and Hernandez R. 2013. Chikungunya virus host-range E2-transmembrane deletion mutants induce protective immunity against challenge in C57BL/6J mice. J. Virol. 87(12):6748-57

Smith KM, Nanda K, Spears CJ, Piper A, Riberio M, Quiles M, Briggs CM, Thomas GS, Thomas ME, Brown DT, and Hernandez R. 2012. Testing of novel dengue virus 2 vaccine in African Green monkeys: safety, immunogenicity, and efficacy. Am. J. Trop. Med. Hyg. 87(4):743-53

Briggs CM, Mayer AE, and Parks GD. 2012. Mumps virus inhibits migration of primary human macrophages toward a chemokine gradient through a TNF-alpha dependent mechanism. Virology. 433(1):245-252 Briggs CM, Holder RC, Reid SD and Parks GD. 2011. Activation of human macrophages by bacterial components relieves the restriction on replication of an interferon-inducing parainfluenza virus 5 (PIV5) P/V mutant. Microbes and Infection. 13(4):359-368

Manuse MJ, Briggs CM, and Parks GD. 2010. Replication-independent activation of human plasmacytoid dendritic cells by the paramyxovirus SV5 requires TLR 7 and autophagy pathways. Virology. 405(2):383-389 Mattos C, Stiller JW, Postava-Davignon M, Rosengaus R. Estimation and identification of bacterial and fungal loads in the termite species Nasutitermes corniger using molecular methods. Explorations: The Journal of Undergraduate Research and Creative Activities for the State of North Carolina. 2006 1:107-21

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