Professional Experience

Confidential, October 2007 to December 2011
Director of Surgical Models and Project Manager

Pre-Clinical Research

• Manages complex surgical and non-surgical projects in large animal species including bovine, ovine, porcine, and canine (Averaging 20 large scale projects per year)
• Drafts protocols and oversees GCP, GLP and non-GLP studies based on submitted outlines and applicable regulatory guidelines including FDA, USDA, and OSHA.
• Chairs Institutional Animal Care and Use Committee (IACUC)
• Drafts SOPs as necessitated by projects and regulatory requirements.
• Manages technical staff and laboratory operations
• Budgets for study efficacy and design. Responsible for managing study budgets ranging from $5k to over $450k

Study Design and Implementation

• Designs projects based on sponsor goals and regulatory requirements including GLP, GCP, FDA, and EU ETS123 guidelines.
• Drafts and reviews budgets for project proposals
• Collaborates with clients on 510k documentation
• Manages surgical and non-surgical study teams in coordinating study schedules and staffing
• Serves as liaison between contracted specialists and company staff for the proper performance of study functions in which external expertise is necessitated
• Maintains surgery suite and equipment including routine and targeted maintenance

Communications

• Acts as company representative in delivering presentations for clients and collaborators
• Trains staff in required techniques and scientific rationales for study design and procedures
• Drafts and reviews marketing and promotional materials

Data Analysis

• Performs statistical analysis of project results in the course of preparing summary results and reports for sponsoring clients.

Confidential
Fort Collins, CO
Sept 2005 to Oct 2007
Senior Project Manager

Responsibilities:

• Managed all live-phase projects, including surgical models, pharmacokinetic studies, toxicology trials, and assessment of efficacy
• Responsible for applicable FDA compliance on GLP and non-GLP projects.
• Performed study-related techniques as necessitated
• Drafted and reviewed protocols and reports related to live-phase research trials
• Interacted directly with study sponsors on study design, reporting, and study-specific issues.
• Installed and operated electronic equipment for analysis of biomechanics of quadruped gait
• Staff Supervision
• IACUC Chair

Confidential
September 2000 to September 2005
Research Coordinator
Department of Laboratory Animal Resources

• Prepared internal and external study proposals for IACUC review
• Coordinated department staff in support of research projects
• Drafted and reviewed reports related to specific studies and required organizational issues
• Managed Pre-Clinical Studies

Confidential
June 1997 to September 2000
Laboratory Manager/Senior Research Associate
Department of Biomedical Engineering

• Supervised and monitored research progress of 3-7 graduate students
• Served as liaison between graduate students and Lab Director Mohammad Kiani
• Designed and implemented study protocols based on proximate and long-term research goals
• Instructed graduate students and faculty in experimental small animal surgery
• Coordinated collaborative research between Kiani lab and Department of Radiation Oncology at St Jude Children’s Research Hospital
• Collated data, performed analysis, and drafted documents for journal submission.

Master of Science
Neurobiology

Bachelor of Science  Biology
Minors in Chemistry, English, Psychology

Khatri A, Gaber MW, Brundage RC, Naimark MD, Hannah SK, Stewart CF, Kirstein MN. Effect of Radiation on the Penetration of Irinotecan in Rat Cerebrospinal Fluid. Cancer Chemother Pharmacol. 2011 68(3): 721-31

Gaber MW; Yuan H, Killmar JT, Naimark MD, Kiani MF, Merchant TE. An intravital microscopy study of radiation-induced changes in permeability and leukocyte-endothelial cell interactions in the micro vessels of the rat pia matter and cremaster muscle. Brain Res. Protocol 2004 13(1):1-10

Yuan H, Gaber MW, McColgan T, Naimark MD, Kiani MF, Merchant TE. Radiation-induced permeability and leukocyte adhesion in the rat blood-brain barrier: modulation with anti-ICAM-1 antibodies. Brain Res. 2003 Apr 18;969(1-2):59-69

Gaber MW, Naimark MD, Kiani MF. Dysfunctional microvascular conducted response in irradiated normal tissue. Adv Exp Med Biol. 2003;510:391-5

El-Sayed, M; Kiani, MF; Naimark, MD; Hikal, AH & Ghandehari, H. The extravasation of polyamidoamine dendrimers across the microvascular network endothelium. Pharm. Res., 18(1):23-28.

Selected Abstracts & Presentations:

H. Ghandehari, M. F. Kiani, M. Naimark, M. El-Sayed, F. Tajarobi, J. Polli, and B. Rege, Transendothelial and -epithelial transport of poly (amidoamine) (PAMAM) dendrimers, 2000 Biomedical Engineering Society Annual Fall Meeting, October 12-14, 2000, Seattle, Washington, Proceedings.

M. El-Sayed, M. Naimark, M. F. Kiani, H. Ghandehari
Transport of macromolecular drug carriers across microvascular beds. Presented at the 2000 Fall National Meeting of the American Cancer Society August 20-25, 2000.

M. El-Sayed, M. F. Kiani, M. Naimark, and H. Ghandehari, Extravasation of poly (amidoamine) dendrimers across the microvascular network endothelium, 14th Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists (AAPS), November 14-18, 1999, New Orleans, Louisiana, Proceedings.

M. El-Sayed, M. F. Kiani, M. Naimark, A. H. Hikal, and H. Ghandehari, Extravasation of poly (amidoamine) dendrimers across the microvascular network endothelium, 2nd Annual meeting of the American Association of Pharmaceutical Scientists – Southern Regional Discussion Group (AAPS-SRDG), May 20-21, 1999, Monroe, Louisiana, Proceedings (Best Podium Presentation Award).

Kiani, MF, and Naimark, MD. Dynfunctional Microvascular Conducted Response in Normal Irradiated Tissues. Presented at the Annual Conference of the Federation of American Societies for Experimental Biology, April 17, 1999.

Kiani, MF, and Naimark, MD. Conducted Response in Normal Tissue Microvasculature is Attenuated Following Exposure to Ionizing Radiation. Presented at the forty-sixth Annual Meeting of the Radiation Research Society. Abstract No. P08-135: 1998.