An extremely motivated professional with over 13 years of experience in the clinical research arena in a variety of leadership positions; currently as the Director of Clinical Research Operations for the Presence Health System. Evidenced based with a thorough knowledge of clinical trial project management, the development of departmental and system standard operating procedures, budget/legal negotiations, and multi-site studies projects has resulted in the successful startup this the clinical research organization spanning the 12 hospitals. Additional experience includes roles as a Medical Science Liaison in the biopharmaceutical industry, the startup of a successful pharmaceutical company, the startup of a medical division for a social work agency handling medically-fragile wards of the state, and 4 years in the role of an organ transplant clinical nurse.
New business development is evident by creating a 12-hospital, system-wide clinical research organization responsible for invoicing, reconciling, trial identification, training, interfacing with Executive level management, presentations to board members, conducting regulatory audits of various hospital sites, and writing department and system-wide policy and procedure.
Strong background in developing research protocols with/for investigator-initiated studies, relationship building with a variety of medical practitioners, and the recruitment of new studies funded by pharmaceutical industry.
Using strong strategic skills, innovation, practicality, and fiscally sound methods, support clinical trial initiatives including site identification, trial recruitment and presentation of final approved data (phases 1-4).
Academic studies support the desire to understand the core competencies of various medical disciplines: clinical (nursing), sales/health administration (Masters of Health Administration), medical affairs roles, and director level management (PhD).
Development and implementation of evidenced-based, scientific disease state slide decks, speaker training programs, and field based speaker training
Extensive time in various roles permits a unique understanding of business development and organizational directives including budget development, interfacing with legal departments, contract negotiations, invoicing, reconciling, and regulatory auditing.
Comfortable, confident, and experienced with providing medical education in multiple settings: dinner programs, national/ local conferences, and one-on-one meetings.
DIRECTOR OF CLINICAL RESEARCH OPERATIONS, 05/2012 to Current Presence Health Systems Presence Saint Joseph Medical Center – Joliet, Illinois
Developed, executed, and currently maintain a very successful, growing clinical research organization within in a 12 hospital system.
Collaborate with leaders throughout the system to achieve strategic outcomes, increase market presence, and develop/maintain research policy and procedure.
Actively participate in budget development, contract negotiations, invoicing, reconciliation, and regulatory auditing.
Direct, organize, and execute activities related to industry-sponsored studies, cooperative group trials, and research education for nursing, pharmacists, and physicians.
Oversee the dissemination of research findings via publications and presentations throughout the system.
Facilitate and review all proposed research with investigator's interested in creating protocols with the intent of publication.
Ensure regulatory compliance according to good Clinical Practice, FDA guidance, organizational policy and procedure, and federal and state local laws.
MEDICAL SCIENCE LIAISON, 04/2007 to 11/2011 Zymogenetics/Bristol-Myers Squibb – Seattle, Washington
Launched ZymoGenetics' first commercial product used in general surgery-- recombinant human thrombin.
Approval for use required the development of and presentation of extensive medical education programs for physicians (hematology/Cardiovascular/thoracic/transplant surgeons), hospital pharmacists, group purchasing organizations, and executive management of stand-alone hospitals or health system representatives.
Successfully recruited/supported key physicians and study sites for on-going clinical trials and/or investigator initiated trials.
Routine collaboration with regulatory affairs and clinical teams, provided support for external study sites, internal and external ad hoc training, study protocol reviews, development of standard response letters, and when requested, ghost writing.
Developed and trained commercial speakers, assisted with product pull-through in collaboration with salespersons/management, developed/presented educational programs internally and externally, and effectively responded to unsolicited, off label requests for information focused on the immunological challenges of giving exogenous, zenogeneic animal proteins during surgery.
Provided support for new molecules in pipeline: Atacicept (TACI-Ig) for MS, IFN-.
Interferon lambda) and PEG-IFN-.
PEG-Interferon lambda) for Hep C, Interleukin 21 (IL-21) metastatic melanoma and as an adjuvant for renal cell cancer, anti-IL21 monoclonal antibody (IL-21 mAb) for autoimmune and inflammatory disease states, and anti-IL-31 monoclonal antibody (IL-31 mAb) for atopic dermatitis (preclinical development).
MIDWEST AREA DIRECTOR, 01/2006 to 04/2007 Next Wave Pharmaceuticals – Buffalo Grove, Illinois
Participated in the startup of Next Wave Pharmaceuticals as the fourth employee hired.
Next Wave co-promoted antibiotics and launched a proprietary iron supplement (Rx and OTC).
Strong medical background assisted with clinical trials and regulatory affairs for pending FDA approval in addition to developing all medical training and marketing materials for the proprietary iron product.
Educational platform based on differentiation/treatment/diagnosis of anemia associated with chronic kidney failure
Products: Suprax®, Kids Iron®.
MEDICAL SCIENCE LIAISON
Princeton, New Jersey
Nordisk - 3 positions spanning First employee in the biopharmaceutical unit to move from a sales management position to a medical affairs position.
Strong clinical background associated with clotting factors provided hematologist with continuing education for use in rare hematologic disease states via clinical trials (i.e.
Hemophilia, Bernard Soulier Syndrome, Von Willebrand disease).
Successfully recruited/supported key physicians and study sites for on-going clinical trials in transplant, neurosurgery, trauma, new surgical indications for PI expansion (rhFVIIa), phase 4 registry enrolments (rhFVIIa), and/or investigator initiated trials.
Routine collaboration with regulatory affairs and clinical teams supported internal/external/new hire, and ad hoc scientific disease state training.
Developed/maintained KOL's, trained commercial speakers, assisted with product pull-through in collaboration with commercial team management, and developed/presented educational programs internally and externally.
Very involved in hemostasis/thrombosis registry (HTRS), and hemophilia camps where clinical nursing skills were used to teach patients how to self-infuse factor.
Products: Recombinant human FVIIa (NovoSeven®.
REGIONAL BIOPHARMACEUTICAL SALES MANAGER, 04/2000 to 02/2003 Novo Nordisk – Princeton, New Jersey
Promotion: First employee in the pharmaceutical division to be promoted from a general field sales position to a hospital, biopharmaceutical sales management position.
Creating and implementing unique decile targeting programs led to becoming the top region in the country and revenue increase 1.4 million over 4 years.
Led and coached field representatives who worked closely with hematologists and national/local hemophilia chapters.
Actively participating in annual hemophilia camps using clinical nursing degree to assist and teach patient's self-infusion techniques for required prophylactic factor therapy created strong relationship in this community.
Created and implemented unique field advisory program to streamline internal communication between corporate/sales/medical affairs teams which led to successful synergies and product pull-through.
CLINICAL DIRECTOR MEDICAL AFFAIRS, 09/1994 to 10/1998
Illinois Mentor, 05/1990 to 09/1994 University of Illinois – Crestwood Chicago, Illinois IL
Developed and launched a medical affairs division for a social service agency responsible for placing medically-fragile and emotionally behaviorally disturbed children in foster homes.
Working closely with state regulatory bodies, identified and secured new business with various hospitals and medical care facilities, increasing revenue by over 50%.
Identified, hired, and trained 6 nurses responsible for the education of foster parents on a variety of disease states and mechanical life support devices.
Wrote and published an instructional book on caring for medically and emotionally disturbed children in foster or maternal homes which led to the improvement of patient care and a reduction of sick visits by 35%.
Author - Medically-fragile Child Care in the Foster Home
STAFF RN Organ transplant - kidney/liver/heart/lung.
Masters of Health Administration: 2012 University of Phoenix - Phoenix, Arizona Doctorate of Management in Organizational Learning
Bachelors of Science: Nursing, May, 1987 University of Tennessee/Lewis University - Knoxville Romeoville, Tennessee IL Nursing