Experience

Aastrom Biosciences

• Spain

• Senior Director - Clinical Operations

  • Jul 2010 - Apr 2013

  Ann Arbor, MI Responsible for the Data Management, SAS Programming and Clinical Study Management and Monitoring reporting lines

• Director - Clinical Reporting Systems

  • Apr 2010 - Jun 2010

  Ann Arbor, MI Responsible for the development and delivery of the ‘data out’ deliverables associated with clinical studies.



OptumInsight

• Senior Manager - Research Analysis Programming

  • Aug 2009 - Apr 2010

  Ann Arbor, MI Responsible for 15 colleagues who used SAS in the support epidemiology and pharmacovigilance studies.



Metabasis Therapeutics

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant/Acting Head of Clinical Operations

  • Feb 2008 - Apr 2009

  La Jolla, CA Provided consulting services for various aspects of clinical development focusing on study initiation, data standards, presentation requirements and the development of the data presentations needed for early phase clinical studies.



Pfizer

• Events Services
• 1 - 100 Employee

• Associate Research Fellow

  • Jun 2006 - Feb 2008

  Ann Arbor, MI Reporting responsibility for 4-6 colleagues and a contractor who coordinated and ensured the manufacture and delivery of experimental new treatments in support of toxicology and Phase 1-4 clinical studies. Led/supported Ann Arbor efforts related to implementing tools to better assess project and risk management

• Director-Business Operations

  • Sep 2003 - May 2006

  Ann Arbor, MI Successfully led a cross-functional 10-person team in developing a corporate-wide process for documenting the collection, management, and reporting of efficacy and non-core safety data. Managed the deliverables of two Functional Service Providers who transformed legacy Warner Lambert/Parke-Davis clinical research data (more than 60 clinical studies) to the Pfizer Data Standard. Chaired a worldwide committee to manage the use of SAS software within Pfizer. Led an effort… Show more Successfully led a cross-functional 10-person team in developing a corporate-wide process for documenting the collection, management, and reporting of efficacy and non-core safety data. Managed the deliverables of two Functional Service Providers who transformed legacy Warner Lambert/Parke-Davis clinical research data (more than 60 clinical studies) to the Pfizer Data Standard. Chaired a worldwide committee to manage the use of SAS software within Pfizer. Led an effort (Hepatic Injury Project) that supported the development of a historical research database that crossed legacy companies, compounds, and indications that would aid in drug development decision-making.

• Director-Statistical Analysis and Reporting Department

  • Aug 2001 - Aug 2003

  Ann Arbor, MI Accountable for as many as 40 colleagues (and 20 on-site contractors) who provided SAS programming to support the deliverables associated with Phase 1-3 studies. Led and served as a team member on various committees to bring a single reporting system and data standard to Pfizer. Improved adherence to department speed goals (Planned Tables complete within Five Business Days). 2003’s performance of 93% was a significant improvement over 2002’s 75% and 2001’s 36% on time delivery.



Parke - Davis

• United States
• Facilities Services
• 1 - 100 Employee

• Manager - Clinical Sciences

  • Feb 2000 - Aug 2001

  Ann Arbor, MI Responsible for 4 colleagues and one contractor who provided the SAS-based data presentations and PK/PD datasets associated with more than 50 clinical studies. Delivery responsibility for a Clinical Sciences-based integrated database and data presentations for Pregabalin (now marketed in the US under Lyrica). Designed and developed a prototype SAS-based system to allow the Clinical Sciences Head to visualize the results of Phase 1 clinical studies (see Pharmasug Best… Show more Responsible for 4 colleagues and one contractor who provided the SAS-based data presentations and PK/PD datasets associated with more than 50 clinical studies. Delivery responsibility for a Clinical Sciences-based integrated database and data presentations for Pregabalin (now marketed in the US under Lyrica). Designed and developed a prototype SAS-based system to allow the Clinical Sciences Head to visualize the results of Phase 1 clinical studies (see Pharmasug Best Paper-http://www.pharmasug.org/psug2001/postconf/psug2001pc.html). Show less



Parke Davis

• United States
• Facilities Services
• 1 - 100 Employee

• Manager (for both Clinical Sciences and Clinical Informatics)

  • Aug 1999 - Jan 2000

  Ann Arbor, MI Reporting responsibility for 12 colleagues and the delivery of data presentations associated with approximately 30 Phase-1 clinical studies and managed the development and launch of a standard reporting system for Phase 2-3 study reporting Developed and delivered a class (CPU—Clin Pharm University) with practical exercises to facilitate on-boarding new colleagues and contractors



Parke-Davis

• United States
• Facilities Services
• 1 - 100 Employee

• Supervisor/Manager CRS supporting Clinical Pharmacology & Experimental Medicine

  • Jan 1998 - Aug 1999

  Ann Arbor, MI Responsible for 3 colleagues and the delivery of data presentations associated with more than 50 Phase-1 clinical studies. Facilitated the on boarding of new colleagues, partnered with a Clinical Communications manager to develop a training course that described the drug development process.

• Clinical Systems Analyst

  • Aug 1997 - Dec 1997

  Ann Arbor, MI Developed analysis and data presentations for the Diabetes Therapy team

• Contract SAS Clinical Programmer

  • Nov 1996 - Jul 1997

  Ann Arbor, MI Provided SAS clinical programming services to the Diabetes Therapy Team



Ameritech

• United States
• Telecommunications
• 100 - 200 Employee

• Area Manager/Manager

  • May 1989 - Nov 1996

  Greater Detroit Area Various positions including Results & Analysis, Switching Technical Support & Human Resources Planning



Michigan Bell

• 1 - 100 Employee

• Supervisor/Assistant Manager

  • Jan 1979 - May 1989

  Greater Detroit Area Various positions including Budgets & Planning, Methods, Service Center Operations Staff