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Assoc. Director/Senior Clinical Scientist Resume Example

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ASSOC. DIRECTOR/SENIOR CLINICAL SCIENTIST
Professional Overview

17+ years of pharmaceutical clinical trial experience at Merck (15 yrs) and GSK (2 yrs).

Manage Clinical Trial Programs: supervise all clinical/operational aspects of a clinical trial program - site monitoring, design/implementation of protocols and clinical study reports (CSRs). Provide RN clinical expertise through entire clinical trial process. Deliver studies on time, within budget, and in compliance with ICH-GCP guidelines.  

Core Qualifications
  • Prepare clinical portions of INDs, NDAs, and other regulatory submissions
  • Results driven: author high quality scientific documents based on clinical objectives, data analysis
  • Experienced Regulatory Writer for WW labeling
  • Responsible for answering inquiries from FDA and other agencies
  • Excellent leadership, project management, team building, oral and written communication and presentation skills.
  • Manage CROs
  • Prepare of Investigator Brochures, CRFs, safety monitoring plans, and risk language
  • Develop posters, publications, presentations
  • Assist in financial negotiations, contract development with vendors (CROs, consultants, sites)
  • Develop, manage and track project budgets
  • Review promotional materials in accordance with DDMAC regulations.
  • Holds current RN license
Education
Bachelor of Science: Nursing/Business Management1994Philadelphia UniversityPhiladelphia, PA, USA
Associate of Science: Registered Nursing1982Montgomery County Community CollegePhiladelphia, PA, USA
Experience
Assoc. Director/Senior Clinical Scientist03/1998 to 11/2013Merck & Co., Inc.North Wales, PA

NEUROSCIENCE Therapeutic Area: Received Divisional Award 2012 and Award for Excellence for successful submission of NDA and subsequent FDA approval of drug. Responsible for new IND (prepared responses to FDA inquiries) and IND updates; managed clinical/operational aspects of 9 clinical trials, including site monitoring, protocols and clinical study reports. All were delivered on time, within budget and within ICH-GCP guidelines. Delivered Investigator Meeting presentations. Managed CROs. Co-authored publication (see below). Received Special Achievement Award 2002 for the successful management of the Neuroscience (Neuro, Psych, GI and Ophthalmology) budget. Also prepared capital budget and Long Range Operating Plan as well as cost-time estimates and participation in Capacity Planning Management analysis. Received Special Achievement Award 2002 for decreasing cost (10M) of clinical trials (restructured clinical personnel responsibilities).


ONCOLOGY Therapeutic Area: Received Divisional Award 2006 for the successful submission of NDA for Merck's first oncology drug and subsequent accelerated drug approval. Program management of 3 oncology compounds concurrently: responsible for clinical and operational aspects of 11 protocols and associated CSRs. Also, authored investigator's brochures, compound safety updates and risk management plans. ONCOLOLGY STAFF MANAGER: Received Divisional Award (2006) for creation of a staff training program in oncology that increased staff productivity and decreased cycle time.


REGULATORY AFFAIRS: Successful medical writer for drug labels and received Merck Special Achievement Award 2005 for FDA approval of new indication for a marketed Merck drug which led to increased sales. Worked with marketing and legal departments to review promotional and other product materials in accordance with DDMAC regulations.


Clinical Data Project Manager03/1996 to 03/1998Glaxosmithkline (GSK)Collegeville, PA

Managed all aspects of data management for multiple programs concurrently. Received Impact Award 1997 for Process Improvement for the design, development and implementation of a fast track training program for RNs entering the pharmaceutical industry. Success was demonstrated by the nurses' ability to pass 3 core examinations. This led to increased productivity and decreased cycle time.


Certified Medical - Legal Consultant01/1990 to 03/1996LaSorda Business Services, Inc.Norristown, PA

Self-employed with physical therapists, chiropractors, orthopedic physicians as clients. Responsible for all clients' accounts receivables including the successful negotiation of settlements of clients' claims in litigation. Increased client profit by 25% annually. Managed 5-10 contract employees.

Publications

Seeburger J, Taylor, Newman L, Friedman D, Ge Y, Zhang Y, Hustad C, LaSorda J, Harper Mozley L, Fan X. Hewitt D, Ho T, Connor KM, Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia, December 2010.

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Resume Overview

Companies Worked For:

  • Merck & Co., Inc.
  • Glaxosmithkline (GSK)
  • LaSorda Business Services, Inc.

School Attended

  • Philadelphia University
  • Montgomery County Community College

Job Titles Held:

  • Assoc. Director/Senior Clinical Scientist
  • Clinical Data Project Manager
  • Certified Medical - Legal Consultant

Degrees

  • Bachelor of Science : Nursing/Business Management 1994
    Associate of Science : Registered Nursing 1982

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