Manager Project
Resume:
Douglas L. Larsen
Spring Hill, Kansas 66083
Home: 913-***-****
Mobile: 913-***-****
Email: ***********@*****.***
CAREER GOAL
A position in clinical or preclinical research and development that provides opportunities to enhance my experience in clinical drug development, provide team and/or client interactions, growth opportunities and the ability to apply my knowledge and experience to support the successful discovery and development of new marketable products.
SKILLS
• Ability to execute and deliver projects on time and within budget
• Effective written and oral communication
• Positively influence and guide team members in accomplishing tasks
• Effectively manage client relationships and expectations
PROFESSIONAL EXPERIENCE HIGHLIGHTS
• Increasing responsibilities in both CRO and large Pharma environments from bench level research to participation in multidisciplinary project teams and development of regulatory submissions.
• Manager of site Radioanalysis Laboratory
• Study Director in both preclinical GLP and non-GLP environments. Responsible for the design and implementation of pharmacokinetic, toxicokinetic and metabolism programs for early screening projects and development programs
• Experienced with:
o development of regulatory summaries for submission
o use of typical toxicology, and ADME species
o compartmental and non-compartmental pharmacokinetic analyses
o toxicokinetic analyses
o data acquisition systems (Debra)
o protein binding
o the use of radioisotopes (primarily 14C, 125I, and 3H)
o development of both large and small molecules
o nonclinical formulation
o evaluation of human dosimetry and radioanalysis of clinical ADME studies
PROFESSIONAL EXPERIENCE
Xenometrics, LLC, Stilwell, Kansas
Senior Scientist
January 2009–September 2011
• Provided scheduling and formulation support for GLP and non-GLP pharmacokinetic, ADME, and toxicology studies
• Formulated complicated mixtures, multiple compound formulations, and radiolabeled test articles
• Provided analysis and interpretation of toxicokinetic (TK) and pharmacokinetic data from pharmacokinetic, ADME, and toxicological studies for internal and external clients
• Provided functional leadership for development projects from initial development activities through late stage
• Served as mentor/trainer with regard to pharmaceutical development, formulation preparation, use of radioisotopes, and regulatory guidelines
• Recommended potential capital expenditures and manpower requirements to maintain departmental function
• Responsible for project progress and identification of future direction with assistance from supervisor
• Provides input for estimating resource requirements in order to determine cost estimates for projects included in proposals
MPI Research. Mattawan, MI
Senior Study Director
October 2006 – December 2008
• Provided interaction with external clients for study consultation, design, and implementation
• Responsible for the scheduling, conduct, performance, monitoring, interpretation/evaluation of results, and reporting of various DMPK or other types of studies performed within MPI Research
• Managed staff and facility resources as necessary to deliver projects on time and within budget.
• Provided leadership and direction in the expansion of capabilities within the ADME department, and support business development, budgeting, and marketing of MPI Research preclinical services.
Aptuit, Inc. (and Predecessor Companies) 1977-2006 Kansas City, MO
Aptuit, Inc. Kansas City, MO
Senior Scientist
October 2005 – September 2006
• Manager of the radioanalysis laboratory.
• Study Director in Preclinical Technologies. Designed and conducted early stage non-GLP in vivo bioavailability and formulation screening studies and comprehensive GLP pharmacokinetic and mass balance studies
• Project costing
• Toxicokinetic analysis and reporting
• Contributed to regulatory summaries.
• Client interaction and support
Quintiles, Inc. Kansas City, MO
Senior Associate Scientist
January 1999 – September 2005
• Study Director in GLP ADME Group. Designed and conducted non-clinical ADME studies, toxicokinetic studies, protein binding studies and characterization of binding interactions.
• Project costing
• Human dosimetry evaluation in support of clinical ADME studies
• Radioanalytical support of clinical mass balance studies
• Conducted early stage non-GLP in vivo bioavailability screening. Provide data analysis and reporting.
• Contributed to regulatory summaries
• Provided client interaction and support
Hoechst Marion Roussel, Inc. Kansas City, MO
Associate Scientist
1995 – 1998
• Study Director in GLP ADME Group. Designed and conducted non-clinical ADME studies and toxicokinetic studies
• Human dosimetry evaluation
• Established protein binding laboratory for characterization of drug/protein interactions.
• Conducted early stage non-GLP in vivo bioavailability screening. Provide data analysis and reporting.
• Contributed to regulatory submissions and summaries for products such as Allegra, Flavoperidol
• Participated on Project teams for antiviral and oncolytic compounds
Marion Merrell Dow, Inc. Indianapolis, IN/Kansas City, MO
Pharmacokineticist
1990 – 1995
• Study Director in GLP ADME Group. Designed and conducted non-clinical ADME studies and toxicokinetic studies,
• Provided technical support, data analysis and reporting in the Pharmacokinetics Group
• Established protein binding laboratory (Kansas City) for characterization of drug/protein interactions.
• Conducted early stage non-GLP in vivo bioavailability screening. Provide data analysis and reporting.
• Contributed to regulatory submissions and summaries for antihistamines and oncolytics
Dow Chemical Co., Inc./Merrell Dow Pharmaceuticals, Inc., Indianapolis, Indiana
Biologist/Pharmacokineticist
1977–1990
• Provided technical support, data analysis and reporting in the Pharmacokinetics Group of the Toxicology Department. Subsequently served as Study director. Designed and conducted non-clinical ADME studies and toxicokinetic studies
• Established early evaluation of toxicokinetic data within in toxicology studies
• Conducted protein binding studies
• Assembled and tabulated data for regulatory submissions
• Conducted early stage non-GLP in vivo bioavailability screening. Provide data analysis and reporting
• Contributed to regulatory submissions and summaries
• Constructed and developed pharmacokinetic and graphics software
PUBLICATIONS
• Bullock,P., Larsen, D., Press,R., Wehrman, T., and Martin, D. E. The absorption, distribution, metabolism and elimination of bevirimat in rats. Biopharm. Drug Dispos. 29:396-405, 2008.
• Shinn,C., Larsen, D., Suarez, J. R., Buj,V., Petric, R., Pearson, M. D., Flinn, I. W. Levasseur, L., Grever, M. R., Byrd, J. C. Flavopiridol sensitivity of chronic lymphocytic leukemia (CLL) cells in vitro varies based upon species specific drug protein binding. Blood 96(11), p294B, 2000.
• Chang, J. Wilson, D. D., Broward, S. M., Smith, K. A., Larsen, D. L., Stuhler, J. D., Zadjura, L. M., Ho, J. C., Rose, J. Q. Absorption and disposition of oral and intravenous doses of the potential anticonvulsant MDL27,192 in rats and dogs. Pharm-Res. 11, No. 10. Suppl. S347, 1994.
• Gordon, WP. Cheng, H. Larsen, DL. Ragner, JA. Landmesser,NG.
Identification of urinary metabolites of 8-methyl-8-azabicyclo(3,2,1)octan-3-yl 3,5- dichlorbenzoate (MDL 72,222) in the dog and monkey. Drug Metabolism & Disposition. 20(4):596-602,1992.
• Cheng, H. Larsen, DL. Ragner, JA. Sproles, GD. Gordon, WP.
Disposition of 8-methyl-8-azabicyclo(3,2,1)octan-3-yl 3,5-dichlorbenzoate, a potent 5-hydroxytryptamine antagonist, and two metabolites in dogs and monkeys. J. Pharm. Sci. 81(Apr): p 345-347. 1992
EDUCATION
Butler University; Indianapolis, Indiana
May 1986
• Master of Science in Pharmacology,
Central Michigan University, Mt. Pleasant, Michigan
May 1977
• Bachelor of Science with majors in Chemistry and Biology,
• Mathematics minor
• Graduated Magna Cum Laude
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