Robin A. Owen, Ph.D. Email & Phone Number

Leverkusen, North Rhine-Westphalia, DE

Leverkusen, North Rhine-Westphalia, DE

Leverkusen, North Rhine-Westphalia, DE

Managing a team of Country Lead Monitors (Project Managers) for Bayer's Clinical Trial program in Canada.

Mississauga, Ontario, CA

• Acerus Pharmaceuticals is a Canadian based pharmaceutical company focused primarily on men's and women's health. Primary product was Natesto, a novel, new testosterone nasal gel. Being a small company the Clinical.
• direct responsibility of all clinical trial including design, site recruitment, enrolment, study reports, and management of vendors including CROs
• primary trial is a phase 4 with Natesto to synchronize with product launch across Canada at 10 key sites
• clinical input and control of PIP (paediatric investigation plan) linked to MAA submission for Europe
• coordination of publications in peer review journals for existing data and prospective data from clinical trails
• presentation of data/posters at key scientific symposia

Durham, North Carolina, US

• management of pharmacovigilance center handling end-to-end case processing
• secured 4-year contract extension
• improved and sustained tier 1 & 2 metric deliverables particularly around quality and compliance
• strengthened client relations despite change management at client
• ensured inspection readiness
• evolved 1st and 2nd line managers into effective leadership team

• I have worked with a cross-spectrum of pharma related companies to provide liaison with key opinion leaders, clinical trial management, pharmacovigilance leadership, BD, direct sales and marketing. Some of the contract.
• Promoting new medical device for diabetic foot ulcer and other wounds to KOLs and liaison with managed care groupsReal Aesthetics (Jan 2009 – Nov 2012): FDA Consultant
• Advice on FDA submission and approval for fat/cellulite breakdown deviceAlfaTeck USA Medical Systems: Medical Liaison & Director of Sales/Marketing (Jun 2007 – Nov 2012)
• Full global safety monitoring
• Clinic set-up
• Device sales and managementAlfaTeck USA Medical Systems: Interim CEO (Sep 205 – May 2007)

• served as primary contact for program strategic planning and resolution of significant issues for global trial program in Parkinson’s disease (North America, Europe, Rest of World)
• maintained overall awareness of developments in the field of clinical research & key therapeutic areas
• developed a program plan in collaboration with key clients and project managers, maintained positive relationship, gave constructive feedback, defined and met target deliverables, on-going contract negotiations with.
• ran investigator’s meeting – client’s global clinical director felt it was the best launch she had attended
• provided leadership/training to project managers throughout all aspects of study management
• provided input into final study report – successful sign-off by client and FDA-submission

management clinical trials and new business development; development of EDC system

• management of clinical trial/medical aspects of life-cycle plan for Troglitazone (type 2 diabetes)
• developed protocols, phase III and phase IV written simultaneously in 6 weeks
• large studies, IV 65 sites and 520 patients; III 14 sites and 280 patients
• managed all clinical aspects of external relations, particularly key opinion leaders
• trained specialist field representatives with respect to trials and product
• managed budgets and financial planning

Indianapolis, Indiana, US

Project managed 10 clinical trials for human insulin analogue (Lilly referred to their PMs as CRAs); assisted in product launch for Canada.

consulted with healthcare professionals to conduct national phase 4 epidemiology assessment in diabetes

Post-Doctoral Fellowship, Microencapsulation Of Beta-Cells For Transplantation

Ph.D., Diabetes/Biochemistry

B.Sc. (Hons), Applied Biology