| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Street Address
Cell: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEProfessional OverviewClinical Investigations Leader/Manager with 34 years of global drug development experience in a collaborative environment. Interfaced with corporate executives, stakeholders and partners; and influenced across diverse networks to facilitate achievement of business needs. Specialty areas include: Risk-based monitoring; Non-Interventional studies; Investigator-sponsored research; Phase II-IV internal medicine, rare diseases, gastrointestinal, infectious diseases, neurosciences and vaccines programs; and development and implementation of diversity standards for clinical trials.Core QualificationsStrategic planning/executionSeasoned writer/communicatorRisk managementProcess improvement/Staff development Clinical trial diversity SMEBudget development and management/forecastingStakeholder/vendor partnershipsSponsored research programsAccomplishmentsNational Association for the Advancement of Colored People - Durham Branch, Health Committee Chair (2002/2003); Treasurer (2004-2012); Assistant Treasurer/Freedom Fund Banquet Chair (2013present).North Carolina Central University Motivational Task Force, Office of Alumni Relations, Planning Committee Co-Chair, 1996-2012.GSK Women in Science Scholars Program, N.C. GSK Foundation. Mentor, 1993-2012.2008 Multicultural Marketing & Diversity Awards: Impact Award, U.S. Clinical Diversity Momentum Team.2005 Diversity Ambassador, Multicultural Marketing & Diversity Awards.2005 Multicultural Marketing & Diversity Awards: Operational Distinction: Diverse Patient Representation in Clinical Trials, Global Clinical Operations (GCO) U.S. Diversity Advocacy Team.R&D Diversity Representative on Multicultural Marketing & Diversity Awards Selections and Steering Committees (US Pharma).Featured in eSpirit and GSK external website for diversity achievements. Interviewed/cited in The Centerwatch Monthly (November 2005, Volume 12, Issue 11) for diversity in clinical trials.Consortium of Undergraduate Researchers & Technologists - National Science Foundation St. Augustine's College, Raleigh, NC, 1999.National Science Foundation External Advisory Board, St. Augustine's College, Raleigh, NC, 1998.National Black Leadership Initiative on Cancer - Rural Intervention/Evaluation Program, 1992EducationNorth Carolina Central University, Durham, NCMaster of Science, Biology, 1981Bachelor of Science, Biology, 1980ExperienceNorth Carolina Central University, Biomanufacturing Research Institute and Technology Enterprise (BRITE), Durham, NCClinical Research Sciences Program (CRSP) Instructor/Guest Lecturer, Dept. of Pharmaceutical SciencesJan 2021 to Jan 2024Create content/related syllabus for courses in the CRSP curriculum designed to groom students in the core competencies and provide hands-on experience in preparation for a career in Clinical Research. Develop and teach online Clinical Rotations course. Mentor Graduate students in the Clinical Research Sciences CertificateProgram. Coordinated 2022 Summer Workshop: Entrepreneurial Opportunities in Clinical Research.Parexel International Corp., Durham, NCSep 2019 to Jun 2023Sr. Study ManagerFSP for American multinational pharmaceutical/biotechnology corporation ranked in top 10 worldwide (2023) by NYSEResponsible for adult (9) and pediatric (1) trial oversight of contract research organization (CRO) for end-to-end clinical trial activities, including risk-based monitoring, with subsequent delivery to plan, and in alignment with business strategy for assets in the Vaccines portfolio. Coordinated end of study lessons learned for interventional and non-interventional studies to facilitate creation of best practices and continuous process improvement. Co-lead for non-interventional studies working group for study management team.IQVIA, Morrisville, NCFeb 2015 to Aug 2019Sr. Clinical Lead, ManagerOct 2016 to Aug 2019Responsible for meeting overall clinical delivery of rare diseases and vaccines programs in accordance with contractual requirements by: managing the clinical operational aspects of projects and risk management plans; representing clinical delivery with the customer driving the principles of productivity, delivery and quality; working closely with the project leader on clinical issue resolution, while remaining ultimately accountable forclinical teams results, including recruitment, CRA resourcing/training plan, quality monitoring and project status reporting; and delivering the project according to the quality management plan, SOPs, policies and practices. Also, participation in function and/or corporate initiatives, special project assignments, and bid-defense meetings with potential clients.Sr. Clinical Project ManagerFeb 2015 to Oct 2016Responsible for management of the scope of work, project objectives and quality of deliverables in accordance with SOPs, policies and practices, on time and within budget by: serving as primary contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to; ensuring the development of project plans for all phases of the project life cycle, including the quality and risk management; developing proactive contingency plans to mitigate clinical risk; supporting cross-functional activities to ensure milestones are met; and assessing/implementing continuous improvement for assigned projects/programs.GlaxoSmithKline, Research Triangle Park, NCAug 1991 to Sept 2012Clinical Investigations Lead / Development Scientist, Neurosciences Medicines Development Center (MDC)Nov 2005 to Sept 2012Study-accountable lead for investigator-sponsored studies (ISS) for MDC joint venture asset responsible for program governance: managed program budget, negotiated investigator contracts, represented MDC on ISS Quality Council, provided monthly updates to department heads, chaired Joint Review Team consisting of internal stakeholders/external collaborators, led review of proposal requests, and ensured business needs of partners did not compromise compliance with company standards.Participated in first joint Sponsor audit by US (FDA) and German (BfArM) regulatory agencies: assisted with overall preparedness of joint venture partner prior to audit and followed up as indicated during the audit.Facilitated the achievement of program objectives by driving team behaviors; interfacing with/influencing across a diverse and scientifically advanced population including external experts/HCPs, regulators, payers, consultants, investigators, and commercial staff; implementing new business processes; proactively identifying issues; and advising/implementing strategies to manage implications and risk to program timelines and budget.Contributed to the successful regulatory approval of Horizant for post herpetic neuralgia: applied operational expertise; independently formulated strategy and executed appropriate actions; maintained an awareness of business drivers; proposed alternative solutions for project delivery; built/maintained stakeholder and partner networks; influenced at project, departmental and cross-departmental levels; and shared individual learning to ensure continuous improvement.Led/Developed departmental training overview to facilitate transition to more encompassing Development Scientist role for staff in Development Sciences, Marketed Products, and Emerging Pipeline.Global Clinical Operations (GCO) program representative for ropinirol, included program oversight and budget management.Participated on key process improvement initiative teams in support of simplifying clinical development effort. Piloted new processes as well as provided global staff training.Oversaw performance and development of 8-10 direct reportsWrote IND/NDA annual reports, annual safety reports and clinical study reports; and ghost writer for Vice President, GCO, NAContinued co-leadership of Diversity Advocacy Team: ingrained, sustained and improve momentum of this effort over time. Resulted in achievement of alignment with U.S. population demographics.U.S. Coordinator, Focus on the Patient, Office of the Chief Medical Officer (OCMO)Nov 2011 to Apr 2012 (6-month assignment)Facilitated the development/delivery of global broadcast insight seminars for Focus on the Patient, an established and highly valued program sponsored by the CMO focusing on strengthening the patient voice in GSK.Participated as U.S. representative on Patient Insight Seminar Steering Team consisting of CMO andTherapy Area Heads: raised topics for future seminars; shared feedback on U.S. based events, includinglessons learned and input for continuous improvement; and interacted with U.S. based Site Leaders to encourage their support of staff attendance - drafting staff communications for their use.Coordinated development of a patient montage video. Spearheaded the design of the Focus on the Patient poster (6) campaign entitled The Voice of the Patient in Our Work containing messages from patients to GSK staff on the importance of research, and the Diversity in Clinical Trials session.Wrote seminar follow up articles for GSK R&D Home website.Associate Director, Neurosciences MDCJun 2001 to Oct 2005Contributed to the overall life cycle management of various assets in the Neurosciences portfolio by providing end-to-end oversight of clinical development activities with subsequent delivery to plan in alignment with business strategy while ensuring compliance with GCP, federal regulations and company SOPs/best practices.Applied operational expertise in delivery of Imitrex injection morning migraine studies.Contributed to the successful regulatory approval of ropinirole CR for Restless Legs Syndrome.Spearheaded initiative across the corporate strata to facilitate achievement of R&D diversity objectives to increase diverse patient and investigator representation in U.S. clinical trials in alignment with federal regulations.Led the global implementation key study centre identification strategy in partnership with global GSK staff to support priority programs.Oversaw performance and development of 8-10 direct reports.Wrote annual and clinical study reports. Ghost writer for Vice President, Global Clinical Operations, N.A.Oversaw vendor contract negotiations.Study Team Leader/Sr. Clinical Research Scientist, Infectious Diseases & HepatitisJul 1994 to May 2001Led the implementation of worldwide influenza prevention programs. Responsible for global budget development and management, vendor/study center contracts and payment disbursements.Served as point of contact for U.S. military sites liaison.Clinical representative on Health Outcomes/Epidemiology component teams.Clinical Research Scientist, Zantac Medical AffairsAug 1991 to Jul 1994Executed/monitored ulcer treatment trials to demonstrate superiority over competitor compounds.Developed unit training program to support staff continuing education.Coordinated preparation of and wrote introduction for annual reports.Clinical Research International, Research Triangle Park, NCJan 1988 to Aug 1991Clinical Research Scientist/Lead CRAMonitored clinical trials as indicated by sponsor and created study newsletter.Developed company CRA training program.PublicationsZhang L., Rainka M., Freeman R., Harden N.R., Bell C.F., Chen C., Graff O., Harding K., Hunter S., Kavanagh S., Laurijssens B., Schwartzbach C., Warren S., McClung C. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN110748). Journal of Pain 14(4), April 2013Hogan D.L., McQuaid K.R., Koss M.A., Crombie D.L., Hunter S.A., Metz C., Euler A.R. and Isenberg J.L. Gastric acid suppression is greater during intravenous ranitidine infusion versus bolus injections of famotidine. Aliment Pharmacol 7:PHONE NUMBER AVAILABLERuffin J. and Hunter S. An evaluation of the side effects of garlic as an antihypertensive agent. Cytobios 37: 85-89, 1983.ManuscriptsA Phase IIa, Randomized, Crossover Trial of Gabapentin Enacarbil for the Treatment of Postherpetic Neuralgia in Gabapentin Inadequate Responders. (PXNPHONE NUMBER AVAILABLEMembershipsGSK African American Alliance, 2008 - 2012GSK Partnership for Educational Development, 1998 - 2000Drug Information Association, 1991 - 2000 |
