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

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 Director's role was diverse and included the following domains/responsibilities:• 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 • development of clinical trials, particularly phase 1, for new chemical entities• input and review on clinical aspects of promotional materials• management of medical queries• management of SAEs/AEs• medical affairs role in building KOL• review and support of regulatory submissions particularly to HC• related assessment and management of vendors (CROs/central labs/pharmacovigilance)

• 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• extensive operations and process enhancement• staff retention in an aggressive hiring market

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 positions were (with some overlap):UltraHeal Medical Systems (Nov 2011 – Nov 2012) : Senior Medical Liaison• 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)• Corporate governance• Obtained 510k approval• Product launch – 11 devices initially ($100,000 per)DP Clinical Inc (Mar 2011 – Feb 2012) : Medical Liaison/Manager BD• Business development for CRO with focus on spinal cord injuryIn3 Ventures: Endothelix/ThermaRx/IC Therpeutics/AmeRejuve : Interim COO/Medical Liaison (Jan 2007 – Jan 2008)• Corporate governance of umbrella management group with 5 subsidiary start-up companies• Establish corporate structure within and between companies including Advisory Boards/SABs• Capital raise• Oversee IP – 11 patents filed• FDA approval for Endothelix with subsequent extension of indication• Clinical trial program management• HR managementMedical Research Consultants (Jun 2004 – Jun 2006) : Medical Liaison• Expand scope of services for medical litigation support services company – focus on major pharma and med device litigation • Special focus on BD with key go-to law firmsEndPoint Research : Director of US Operations (Sep 2002 – May 2004)• Manage all aspects of expansion of Canadian CRO into US including personnel recruitment, office set-up, business development, P&L, strategic planning

•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 clients and vendors – initial contract was $1.6MM under my direction grew to $6.8MM•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•mentored and lead project management team (7 direct project manager reports, 18 in total) on project-related tasks and issues [CNS/diabetes/cardiology/oncology/ophthalmology]•routinely assisted with the assessment of status of project deliverables and budgets for each project – company never lost a single client during course of management•assisted project managers with the identification and resolution of critical issues•significantly contribute in senior management meetings, establish budgets, managed growth•business development, including attending and participating in meetings with potential clients, and assisting with proposal and budget development•assisted in development, review, and maintenance of SOPs – external auditor for primary client stated the SOPs were the most thorough she had seen and were being followed almost perfectly, especially records management

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•established contracts with external CROs, laboratories etc.•global head of clinical stated that phase III trial had produced the most meaningful data he had seen from a trial•expert review of submissions, publications etc. relating to product; e.g. HPB/FDA submissions

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