Date Available:
immediately

Location Desired:
Southeast U.S. or Texas

Objective:
Director or VP level position in Medical Affairs, Clinical Affairs, Clinical Research, Regulatory Affairs, or R&D with a biotech or specialty pharma company in the southeast U.S. or Texas

Education
AB Biology
MS Biology
PhD Biology

Biotechnology Skills
Please see Work Experience for Skills and Achievements

Work Experience
2005-Current
Independent Consultant for Pharmaceutical/Biotech/Medical Device Companies
Responsibilities: Consult for pharmaceutical, biotech, and medical device companies regarding non-clinical and clinical drug development plans, Phase I-IV clinical trial design and implementation, INDs, NDAs, 510(k)s, annual reports, medical education, prescription drug promotional material and labeling, and regulatory issues/strategies in multiple therapeutic areas including diabetes, dermatology, arthritis, pain, oncology, GI diseases, Women’s Health, and renal failure involving small molecule drugs, gene and cell therapies, or medical devices.

2003-2004 Director, Medical and Scientific Affairs
Takeda Pharmaceuticals North America Inc.
Responsibilities: Managed the External Grants (Investigator Initiated Studies, CME), Outcomes Research, and Clinical Publications (INDs, NDAs, Investigator Brochures, Clinical Trial Study Reports) departments in support of Takeda’s life-cycle management of ACTOS (insulin sensitizer for type 2 diabetes) and other newly developed drugs. Directed strategy, design and interpretation of Phase IIIB/IV trials for ACTOS, medical review of promotional and medical educational material, preparation of label changes, and management of a multimillion dollar budget for 3 departments. Three managers (PhDs), scientists, grant coordinators, and medical writers reported to me (total of 27 employees).
Major Accomplishments: Over 100 investigator trials are in progress for ACTOS resulting in numerous manuscripts and posters that support the life cycle strategy for the drug. Two Phase IIIB/IV trials are in progress to support a cardiovascular indication for ACTOS. Recipient of the Takeda Commitment Award for creative contributions to the ACTOS commercialization team.

2002-2003 Vice President, Research & Development
NephRx Corp. (Biotech Company)
Responsibilities: Directed the scientific/nonclinical and clinical development of novel growth factors for potential treatment of acute renal failure, gastrointestinal disorders (gastroduodenal ulcer, inflammatory bowel diseases, and gut-derived sepsis), and cutaneous wound healing. Designed experiments, hired lab personnel, designed and equipped lab, contracted studies to CROs, updated NephRx board on R&D progress, prepared patent applications and grant proposals, and lead scientific/preclinical development milestone agreement with major Pharma partner. Scientists and lab assistants reported to me.
Major Accomplishments: Prepared 2002 nonclinical research and development plan for NephRx gastric peptide and conducted experiments in animal models of gastrointestinal disease. Completed orphan drug designation application and development plan (IND) for NephRx renal peptide (acute renal failure) from nonclinical toxicology through proof of concept clinical trial in renal transplant patients with acute tubular necrosis.

1981-2002 The Upjohn Company/Pharmacia and Upjohn/ Pharmacia Corp. (Pfizer Legacy Companies)

2001-2002 Director, Worldwide Prescription Drug Labeling and Promotional Material Pharmacia Corp. Global Regulatory Affairs
Responsibilities: Directed the Product Labeling unit in Global Regulatory Affairs. This involved direction and prioritization of labeling projects for development and/or revision of U.S. Physician and Patient Inserts, SmPCs, and Core Data Sheets for both new and mature prescription drugs in all therapeutic areas. Review of promotional and medical educational material was conducted. The unit also had responsibility for approval of carton and bottle labels. Two associate directors, 4 regulatory managers, 1 technician, and 1 administrative assistant reported directly to me. I had management responsibility for three sites, Kalamazoo, MI, Skokie, IL and High-Wycombe, UK. Along with mgmt responsibilities, I carried a near full-time equivalent labeling project workload.
Major Accomplishments: Development and revision of inserts and core data sheets and medical review of promotional and educational material for drugs in the areas of diabetes (GLYSET), arthritis (CELEBREX, BEXTRA, DYNASTAT, ARTHROTEC, AZULFIDINE), GI Diseases (AZULFIDINE, DIPENTUM), Women's Health (DEPO-PROVERA, LUNELLE, PREPIDIL GEL, ESTRING, VAGIFEM, DOSTINEX), CNS (XANAX, HALCION, AMBIEN), cancer (CAMPTOSAR) and cardiovascular (INSPRA). Recipient of Pharmacia Pride Award for innovative labeling of AZULFIDINE-methotrexate combination.