Dr. Edward P. Monaghan

Berufserfahrung von Edward P. Monaghan

• Bis heute 16 Jahre und 6 Monate, seit 2008

  Vice President, Clinical Operations

  TRF Pharma, Inc.; Burlingame, CA

  Responsible for generation of INDs, interactions with the FDA, and development and oversight of clinical programs for a novel treatment of pain caused by sickle cell disease.

• Bis heute

  President/Owner

  SOAR Pharmaceutical Development Services

• 6 Monate, Mai 2007 - Okt. 2007

  Head, Clinical & Regulatory

  N.V. Organon; Irvine, CA

  Part of Organon transition team following acquisition of Kadmus' technology.

• 2002 - 2007

  Vice President, Drug Development

  Kadmus Phamaceuticals, Inc.

  Responsible for generation of INDs and CTAs, interactions with the FDA and TPD, and development and oversight of preclinical toxicology and clinical programs for novel CNS-active compounds for therapeutic indications including pain, depression, and anxiety. Led to successful sale of the technology, valued at up to $150 MM.

• 1992 - 2002

  Senior Medical Research Specialist

  Serono, Inc., Norwell, MA

  Led an international Phase III tria (EVIDENCE) comparing two active treatments for MS. Directed clinical, data management, biostatistics, and regional CRA activities. Managed a $40MM study budget and surpassed very aggressive timelines.

• 1995 - 1999

  Associate Director, Clinical Research

  CoCensys, Inc.; Irvine, CA

  Led development activities for novel treatment of epilepsy that included presenting to FDA, NIH, and potential partners, preparing INDs and IBs, designing and implementing Phase I and II trials, hiring and training clinical staff, and establishing intra- and inter-departmental Standards Operating Procedures.

• 1992 - 1995

  Principal Clinical Research Associate

  Allergan Inc.; Irvine, CA

  Led Phase II and IV studies in neuro-rehabilitation, including protocol development, site selection/initiation, contract negotiation, investigator meetings, monitoring, data analysis, and report writing.