Innovation Pharmaceuticals Inc (IPIX)

[bradfordbros]

For Edward Walters I copied a Farrell90 post. Hope this helps.

Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients. - See more at: http://cellceutix.com/cellceutix-retains-former-durata-executive-ronald-trust-as-regulatory-affairs-consultant/#sthash.nCeextjG.dpuf

Edward Walters MPH central operations Cellceutix

Past Director of Clinical Operations at PolyMedix, IncDirector of Clinical Operations
Director of Clinical Operations at PolyMedix, Inc
September 2010 – Present (4 years 5 months)
Manage day to day clinical development programs across various therapeutic areas and clinical indications. Overall project management of multiple vendors (domestic and international) for efficiency and cost effectiveness.


Edward J. Walters, MPH
Senior Director, Clinical Development Operations, Epidemiology at Allergan
Allentown, New JerseyPharmaceuticals
Current
Allergan, Director of Clinical Operations at PolyMedix, Inc
Previous
EDON Consultants, LLC, Pharmos, Axonyx
Education
University of Southern Mississippi
178
connectionsSend Edward J. InMailMore options
www.linkedin.com/pub/edward-j-walters-mph/14/a07/a55
Background
Summary
My experience of 25 years of leadership in Clinical Operational and Project Management in the bio/pharmaceutical industry, covering all phases of clinical trials, has been one of increasing responsibilities and challenges, in designing, implementing, and successfully completing clinical programs, across various therapeutic areas. My attention to detail and proven track record of managing internal project teams and external contract personnel, has allowed me to be a part of the success of some of the leading compounds in the market today. I have a successful record of building high performing, cross-functional clinical project teams (internally and externally). I have over 25 years of direct reporting staff management experience as well as direct management of CRO/ vendor partnering. At the same time, I have always been “hands on” with every project. I have both domestic and international project management experience and extensive experience in leading clinical NDA teams on 6 Phase-III NDA Submissions to date and 5 NDA approvals.
Experience

AllerganSenior Director, Clinical Development Operations
Allergan
January 2013 – Present (2 years 1 month)Bridgewater, NJ
Leads and drives all operational and administrative functions in therapeutic area clinical programs by ensuring the execution of epidemiology clinical studies to successfully meet post-approval study requirements. Exercises a high degree of quality, productivity and communication to the department and therapeutic area for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices, appropriate to the type of study. Leads assigned clinical sub-teams to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Provides project and resource management across therapeutic area portfolio. Serve as a member of therapeutic area management team
Director of Clinical Operations at PolyMedix, IncDirector of Clinical Operations
Director of Clinical Operations at PolyMedix, Inc
September 2010 – Present (4 years 5 months)
Manage day to day clinical development programs across various therapeutic areas and clinical indications. Overall project management of multiple vendors (domestic and international) for efficiency and cost effectiveness.
Owner
EDON Consultants, LLC
September 2003 – March 2010 (6 years 7 months)
Provide Project management and day to day clinical operations for Phase I thru IV clinical trials. I have monitored and audited both domestically and internationally. I have created project management and clinical operations at two different companies (Eisai and Andrx). I have over 20 years of successful experience in the industry. Over the past 7 years, I have successfully led project management and clinical operations for two different companies and 4 different compounds. Included was over 200 study sites, across 16 countries, and included over 2000 patients.
Project Management and Clinical Team Leader
Pharmos
January 2007 – October 2009 (2 years 10 months)
• Overseeing project management of national IBS clinical program
• Negotiations of all vendor budgets and responsible for review of all invoices.
• Worked to present quarterly forecasting of budget expenditures and presented to senior management.
• Lead weekly project team meeting with all vendors and company personnel.
(Open)2 recommendations
Jeff Kittrelle
Jeff Kittrelle
Drug Development Consultant
There are few project managers I've worked with who are as experienced, hands-on and knowledgeable as Ed Walters. He is a...View
Harold Doshan, Ph.D.
Harold Doshan, Ph.D.
President at Pharmaconsult Associates
As a consultant to Eisai Pharmaceuticals, and subsequently through other affiliations, I have enjoyed working with Ed...View
Project Management and Clinical Operations Leader
Axonyx
January 2004 – November 2006 (2 years 11 months)
• Responsible for day to day operations of Phase I thru III of multiple clinical programs on multiple continents.
• Overseeing international Alziemers clinical program(s) and the project’s resources and timelines.
• Maintained project budget in access of $20MM, and quarterly forecasting.
• Management of all vendors (CROs, Labs, etc)
VP of Project management and Clinical Operations
Andrx
1998 – 2003 (5 years)
• Created Clinical Operations Department (NJ and FL) and hired personnel
• Responsible for multiple CROs central Laboratories, IRBs, and consultants
• Responsible for multiple department budgets in excess of $30 million dollars.
• Lead project management for multiple projects
• Created Data Management and IT Departments (NJ and FL) and hired personnel (Documented saving in excess of $400 thousand dollars/Yr).
• Created Post Marketing Surveillance Safety Department and hired personnel
. Director of Clinical Operations and Project Mangement
Eisai, Inc
October 1989 – October 1998 (9 years 1 month)
• Negotiation and direct responsibility for multiple contract research organizations and central laboratory services.
• Hiring and direct supervision of clinical monitoring and auditing staff.
• Responsible for project management and coordination of resources for Phase I through IV clinical programs (Aricept™ and Aciphex™).
• Participated in review of clinical data and preparation of final study reports.
• Responsible for implementation of all clinical studies of Aricept™ outside U.S. (Phases I-IV) including new indications program for Aricept™ worldwide.
Schering-Plough PharmaceuticalsSr. Project Manager
Schering-Plough Pharmaceuticals
February 1984 – October 1989 (5 years 9 months)
• Organization and presentation at multicenter investigator meetings.
• Representative at domestic and international symposia/meetings.
• Project management and coordination of numerous protocols for multi-centered NDA program.
• Supervision of field research associates during various clinical programs.
• Assisted in planning for departmental budgets.
• Assisted in organization and implementation of departmental procedures for in-house and on-site clinical monitoring.
• Training of new personnel to industry guidelines and good clinical practices.
• Direct supervision of multiple CROs.
Skills

Top Skills
8CRO

7Clinical Development

7Pharmaceutical Industry

7Clinical Trials

6FDA

5Clinical Research

4Therapeutic Areas

3Regulatory Affairs

3GCP

2Oncology

Edward J. also knows about...
2Infectious Diseases
2Biotechnology
2EDC
2CTMS
1Lifesciences
Education

University of Southern Mississippi
University of Southern Mississippi
Master of Public Health (MPH), Health and Epidemiology
1977 – 1979
Also received degree in Sports Medicine. Did part of training with Dallas Cowboys and New Orleans Saints
Activities and Societies: GRADUATE HONORS Kappa Delta PI – National Honor Society Eta Sigma Gamma – Graduate National Service Honor Society (Vice President) Two Simultaneous Graduate Fellowships
Kean University
Kean University
BS, Physical Education and Biology
1974 – 1977