Clinical Trials Project Leader III Jul 2017 - presentClinical Trials Project Leader II Jan 2014 – Jun 2017Clinical Trials Project Leader I Dec 2010 – Jan 2014Clinical Trial Leadership for multiple government funded (primarily infectious disease) trials totaling > $20M. Oversee virtual matrix teams across 3 companies, NICHD and over 50 (US and global) research sites for the Pediatric Trials Network (PTN) https://pediatrictrials.org/. Lead or led a total of fifteen NICHD task orders totaling almost $20M enrolling nearly 4,500 patients. Lead protocol development team, execute new PTN trial and lead novel, complex pharmacokinetic clinical trial studying > 60 molecules. Partner with business development to create industry and government study proposals to win new business ($5.2M contract won) for the DCRI. Partner with physicians on protocols development. Partner with Regulatory to oversee submission and maintenance of multiple INDs for PTN. Conduct monthly project risk and budget analyses with appropriate team members. Supervised direct report Jan 2012 – May 2013. Provide oversight on analytical laboratory testing for the PTN and expanded PTN’s central laboratory from one to four across to handle increasing analytical workload. Mentor new Project Leaders and PTN staff. Selected by outgoing Clinical Operations Director to sit on a panel of four clinical operations personnel to conduct interviews for three candidates for Director’s replacement. Facilitate PTN Executive Committee meetings as needed. Implemented and facilitate monthly pharmacology meetings to ensure proper oversite of analyses and publications of over 60 drugs of interest. Recipient of Star Performer award in recognition for motivating teams, operational excellence and fiscal management. Facilitate bi-monthly clinical operations networks meetings.

Supervised project teams in the development of compounds from preclinical research candidate discovery through post marketing compound development and life cycle maintenance of marketed drugs for infectious diseases. Assumed increased levels of responsibility via promotion. Collaborated with project teams to set strategic and operational priorities; identified issues, risks, and contingencies and proactively modified development plans to meet changing needs. Increased team efficiency by tracking deliverables and ensuring accountability. Maintained project team and sub team operations to ensure in the exchange of strategic information with operational personnel; obtained updates relative to operations and drafted quarterly reports to share with senior management. Provided regular investor relation updates and ensured that clinical study reports were completed. Ensured regulatory compliance and reviewed safety documents. Reconciled company external project expenses with project plan and budget expenditures. Supported worldwide registration activities and label updates. Experience with following therapeutic indications: HIV, HBV, HCV, NASH, AAH. Facilitated and managed inter-company alliances with LG Life Sciences (Korea), Achillion, and GlaxoSmithKline.- Experience working with Teams comprised of Regulatory, Commercial, Clinical Research, Clinical Pharmacology, Medical Affairs, Drug Safety, Pharmaceutical Development and Manufacturing, Virology, Biology, Toxicology, Finance, Legal and Compliance.- Experience in concurrent management of multiple Project Teams that span 1 or more companies (Alliance Management)- Manager, Project Management (2/06 – 03/08)- Associate Manager, Project Management (3/05 to 1/06)- Senior Project Management Associate (11/02 to 3/05)- Project Planner (01/00 to 10/02)

Project Manager and central point person for sponsor pharma companies; Managed central laboratory supplies, validated methods and provided lab results for clinical trials of 4 pharmaceutical sponsors. Performed investigator site education, collaborated with clinical research scientists, associates, and project managers. Designed customized investigator manuals and laboratory supplies reports, protocol summaries, and requisitions.

QC / QA of bench techs analyses

CA Clinical Laboratory ScientistSpecial Chemistry Lab

Medical Technologist I-IIIMicrobiology Lab