Project Manager Medical

Claudine H. Kos, Ph.D.

Brookline, MA *****, *************@*****.***, Phone: 617-***-****

Professional Experience

May 2008 – December 2011: Toxikon Corporation, Bedford, MA

Title: Account Manager / Project Manager / Study Director

Industry: Contract Research Organization (CRO) specializing in pre-clinical safety & toxicology testing for medical devices & pharmaceuticals being submitted to the FDA for approval for clinical trials.

Achievements:

• Directed efficacy studies of APIs for treatment of ophthalmic indications (dry eye, allergy, glaucoma, AMD).

• Successfully managed large (>$1 million) preclinical programs for IDE & IND applications (biocompatibility, in vivo tox, MTD & PK; in vitro cyto & gen tox; and bioanalytic studies).

• Defined budgets, set study prices and closed deals amounting to >$2.4 million.

• Negotiated master service agreements, project agreements, CDAs and SOWs.

• Secured additional studies from every client program managed.

Responsibilities:

• Overseeing studies per FDA, OECD, and ISO guidelines (efficacy, MTD, bio analytics, method validation, dose verification).

• Managing projects, with close collaboration with clients, contractors and consultants.

• Writing study designs, protocols and reports, overseeing and/or conducting experiments, reviewing and analyzing data, and ensuring accurate documentations of results and conclusions into study reports according to Good Laboratory Practices (GLP) regulations.

• Serving as IACUC committee member.

• Training staff in study-related standard operating procedures.

• Managing staff (multiple technicians and study directors - BS, MS, PhD levels).

• Scheduling and meeting study timelines and quality standards.

October 2003 – May 2008: Human Nutrition Research Center in Aging at TUFTS UNIVERSITY, Boston, MA

Title: Scientist III / Assistant Professor Tufts University

Industry: Academic research in nutrition and cancer prevention

Achievements:

• Secured salary and research funding for four people

• Awarded grants from multiple funding agencies (Tufts, AICR, NIH-R21)

Projects:

• Studied role of dietary calcium and calcium regulated genes in preventive colon cancer

• Designed targeting vector to generate tissue specific animal models

Summer 2006: BWH Office of Corporate Sponsored Research & Licensing, Boston, MA

Title: Research Ventures & Licensing Intern

Industry: Technology Transfer and Licensing

• Prepared non-confidential marketing materials on available technologies

• Compiled information on patent cases for patent prosecution or licensing agreement terms

April 1998-October 2003: BWH / Harvard Medical School, Boston, MA

Title: Research Fellow in Medicine, BWH Renal Division, Department of Medicine

Industry: Academic biomedical research in endocrine, genetic and renal diseases

Achievements:

• Authored dozens of peer-reviewed scientific articles and a book chapter for publication

• Presented talks at international conferences, departmental seminars and lab meetings

• Awarded grants for salary and research funding from multiple funding agencies (BWH, NIH-NRSA)

Responsibilities:

• Designed and implement experimental plan

• Performed literature search

• Supervised technicians and provided technical support to other research fellows

• Carried out library screening and cloning to create DNA constructs for the generation of transgenic animal models of renal, immunologic, bone and endocrine disorders

• Performed genomics analysis of transgenic mice using Affymetrix GeneChip microarray

• Served as Health & Safety Officer for Brigham & Women’s Hospital renal division, attended quarterly meetings, generated minutes, followed up on safety recommendations and injury reports

2001: PROTEOME INC., Beverly, MA (Acquired by BIOBASE in 2005 from Incyte Genomics)

Title: Scientific Curator

Industry: Bioinformatics

Duties:

• Read and extracted information on specific gene properties from scientific literature

• Evaluated and characterized proteins using hierarchical vocabularies and unique terms

• Maintained scientific accuracy and adherence to standards and project guidelines

• Mined databases and tools such as Entrez Gene and OMIM databases, and BLAST

Teaching Experience

Simmons College, Lab Instructor, 2008

Anatomy & Physiology II Lab

Tufts University, Lecturer, 2004 2008

Scientific Principles of Human Nutrition & Food; Practicum in Bioresearch Techniques; Nutritional Biochemistry & Physiology: Micronutrients; Nutritional Biochemistry & Physiology: Micronutrients

Harvard Medical School, Tutor, 2003

Human Physiology: required for 1st year medical students. As tutor, I mediated a small group of students who met to present and discuss clinical cases and guided them to logical and effective lines of reasoning.

Education

BSN Nursing, Simmons College, Boston, MA 2011

PhD Human & Molecular Genetics, McGill University, Montreal, Quebec 1998

BA Biology, Smith College, Northampton, MA 1991

Selected Publications

Vizard TN, O'Keeffe GW, Gutierrez H, Kos CH, Riccardi D, Davies AM. Regulation of axonal and dendritic growth by the extracellular calcium-sensing receptor. Nat Neurosci. 2008 Mar;11(3):285-91.

Bianco SD, Peng JB, Takanaga H, Suzuki Y, Crescenzi A, Kos CH, Zhuang L, Freeman MR, Gouveia CH, Wu J, Luo H, Mauro T, Brown EM & Hediger MA. Marked disturbance of calcium homeostasis in mice with targeted disruption of the Trpv6 calcium channel gene. J Bone Miner Res 2007 Feb;22(2):274-85.

Adams GB, Chabner KT, Alley IR, Olson DP, Szczepiorkowski ZM, Kos CH, Pollak MR, Brown EM, Scadden DT. Haematopoitic stem cell engraftment in the endosteal niche is dependent upon the calcium sensing receptor. Nature 2006;439(7076):599-603.

Kos CH. Special Article: Methods in nutrition science. Cre/loxP system for generating tissue-specific knockout mouse models. Nutrition Reviews 2004;62(6):(1)224-246.

Yao J, Le TC, Kos CH, Henderson JM, Allen PG, Denker BM, Pollak MR. α-Actinin-4-mediated FSGS: An inherited kidney disease caused by an aggregated and rapidly degraded cytoskeletal protein. PLoS Biology 2004;2(6):787-794.

Kos CH, Le TC, Sinha S, Henderson JM, Kim SH, Sugimoto H, Kalluri R, Gerszten RE, Pollak MR. Mice deficient in alpha-actinin-4 have severe glomerular disease. J Clin Invest 2003;111(11):1683-1690.

Kos CH, Karaplis AC, Peng J-B, Hediger MA, Goltzman D, Mohammad KS, Guise TA, Pollak MR. The calcium sensing receptor is required for normal calcium homeostasis independent of parathyroid hormone. J Clin Invest 2003;111(7):1021-1028.

Kos CH, Tihy F, Murer H, Lemieux N, Tenenhouse HS. Comparative mapping of Na+-phosphate cotransporter genes, NPT1 and NPT2, in human and rabbit. Cytogenetics and Cell Genetics 1996; 75: 22-24.

Hartmann CM*, Hewson AS*, Kos CH*, Hilfiker H, Soumounou Y, Murer H, Tenenhouse HS. (*C.M.H., A.S.H., and C.H.K. contributed equally to this publication and are listed alphabetically) Structure of murine and human renal type II Na+-phosphate cotransporter genes (NPT2 and NPT2). PNAS 1996; 93: 7409-7414.

Kos CH, Tihy F, Econs MJ, Murer H, Lemieux L, Tenenhouse HS. Localization of a renal sodium phosphate cotransporter gene to human chromosome 5q35. Genomics 1994; 19: 176-177.

Lev AA, Rosen DR, Kos C, Clifford E, Landes G, Hauser SL and Brown RH Jr. Human ciliary neurotrophic factor: Localization to the proximal region of the long arm of chromosome 11 and association with CA/GT dinucleotide repeat. Genomics 1993; 16: 539-541.

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