Sandeep P. Nair, Ph.D.

29 Blackbird Lane, Aliso Viejo, CA - 92656

Phone: 352.871.2542Fax: 858.435.1933

Email:

Summary of Qualifications

  • Over 4 years of experience in Clinical Research (Biotech, CNS, Oncology and Medical Devices)
  • Extensive knowledge of clinical research, regulatory requirements, good clinical practice
  • Demonstrated project management ability and established track record of basic science and clinical research
  • Demonstrated financial management of multi-million dollar project budgets
  • In-depth ability to think analytically, process scientific and medical data, as well as the ability to multi-task.
  • Ability to analyze and interpret scientific data for publication, and presentation at internal and external venues
  • Ability to lead projects and assignments, and recognized as a consistent Top Performer by Upper Management
  • Ability to supervise and mentor junior staff
  • Possess excellent technical software and hardware skills

Professional Experience

Jul2008– PresentQuintiles Inc., San Diego, CA

Associate Clinical Project Manager

  • Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
  • Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
  • Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
  • Collect information on team performance against contract, customer expectations, and project baselines.
  • Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
  • Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
  • Provide input for the development of proposals for new work and manage project budgets.
  • Provide input to line managers of their project team members’ performance relative to project tasks.
  • Prepare and present project information at internal and external meetings.
  • Participate in proposal development and in the bid-defense process with guidance and supervision.
  • Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.

Jan2007– June 2008AlleghenyGeneralHospital, Pittsburgh, PA

Fellow

  • Manager and Principal Investigator, Aging and Epilepsy project funded by the Epilepsy Foundation
  • Site Coordinator, Managing and coordinating data transfer and research activities.
  • Fellow, NIH funded Clinical trial testing seizure prediction in patients admitted to the Monitoring Unit.

Dec 2006– Jun 2007 Optima Neuroscience Inc., Gainesville, FL

Consultant

  • Provided expertise in integration of seizure prediction and detection technology with existing EEG/Video Acquisition Systems.

Aug2003– Dec 2006J. Crayton Department of Biomedical Engineering, University of Florida, Gainesville, FL

Graduate Research Assistant

  • Worked in hospital and laboratory settingson clinical and pre-clinical electrophysiological data acquisition, and electrical stimulation devices.

Sep 2000– Jun 2001Cognizant Technology Solutions, Chennai, India

Programmer Analyst

  • Programmed database applications for medical insurance companies

Education

Aug2003– Dec 2006University of Florida, Gainesville, FL

Ph.D. Biomedical Engineering Dissertation: ‘Brain Dynamics and Control with Application in Epilepsy’. Core courses: Human Anatomy, Human Physiology, Clinical Preceptorship. Cumulative GPA: 3.66/4.0

Aug2001– Aug 2003University of Florida, Gainesville, FL

M.S. Electrical & Computer Engineering GPA: 3.61/4.0

Aug1996– Aug 2000Cochin University, Cochin, India

B.Tech. (with Distinction) Electronics Engineering

Skills

Applications:MATLAB,EEGLAB,MSOFFICE,MSPROJECT, VISIO, SHAREPOINT, PEOPLESOFT

Programming Languages:FORTRAN, C, PHP, MySQL

Data Acquisition:Nicolet® BMSI 6000, Stellate® HARMONIE

Additional Training:Clinical and PM Courses from Quintiles L&D (Training Transcript available on request)

Honors and Professional Affiliations

2008-2010Five recognitions for Teamwork and One Special Achievement Award from Quintiles

2007Epilepsy Foundation Fellowship for Young Investigators

2006Outstanding Achievement Award from the J. Crayton Pruitt Family Department of Biomedical Engineering

2006Alpha One Foundation Graduate Fellowship from University of Florida, College of Engineering

2004-2006Member, Biomedical Engineering Society, UF Chapter

2003-2008Junior Member, American Epilepsy Society

1996-2000IEEE Student Chapter, CochinUniversity of Science and Technology, India

Research Funding Support

2007– 2008 Epilepsy Foundation, Targeted Research Initiative

2007– 2010National Institutes of Health-NINDS (R01 NS050582)

2007– 2007Pennsylvania Department of Health, Health Research Formula Fund

2006Alpha-1 Foundation

2003– 2005National Institutes of Health-NIBIB (R01 EB002089-03)

Studies

1.A Randomized, Phase 2b, Multi-center Study of XX vs Erlotinib in Patients with Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at least 1 Prior Platinum-based Treatment

2.An Open-Label Study Evaluating the Safety and Pharmacokinetic Interaction between XX and Methotrexate in Rheumatoid Arthritis Patients

3.A Randomized, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of XX in Combination with Methotrexate compared to Methotrexate Alone in Methotrexate-naïve Patients with Active Rheumatoid Arthritis (Phase III)

4.A Randomized, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of XX Compared to Placebo in Patients with Active Rheumatoid Arthritis continuing Methotrexate Treatment (Phase III)

5.A Randomized, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of XX Compared to Placebo in Patients with Active Rheumatoid Arthritis Who Have an Adequate Response to at least One Anti-TNF-α Therapy (Phase III)

6.A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of XX in Adult Epilepsy Patients with Partial-Onset Seizures

7.A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XX in Patients with Opioid-Induced Consitpation

Publications

1.Nair, S.P., Shiau, D.S., Principe, J.C., Iasemidis, L.D., Pardalos, P.M., Norman, W.M., Carney, P.R., Kelly, K.M., Sackellares, J.C. An investigation of EEG dynamics in an animal model of temporal lobe epilepsy using the maximum Lyapunov exponent. Experimental Neurology, Vol. 216(1), pp. 115-121, 2009.

2.Nair, S.P., Shiau, D.S., Jukkola, P.I., Quigley, M., Wilberger, A., Sackellares, J.C., Kelly, K.M. Absence seizures as resetting mechanisms of brain dynamics. Cybernetics and Systems Analysis, Vol 44 (5), pp. 664-672, 2008.

3.Nair, S.P., Shiau, D.S., Iasemidis, L.D., Norman, W.M., Pardalos, P.M., Sackellares, J.C., Carney, P.R., Seizure Predictability in an Experimental Model of Epilepsy. In: Data Mining in Biomedicine, Pardalos,P.M.; Boginski, V.L.; Vazacopoulos, A. (Eds.), Series: Springer Optimization and Its Applications, Vol. 7, 2007

4.Nair, S.P., Pardalos, P.M., Yatsenko, V.A., Optimization in control and learning in coupled map lattice systems. J. Optimization Theory and Applications. Vol. 134, No. 3, pp. 533-547, 2007.

5.Nair, S.P., Sackellares, J.C., Shiau, D-S., Norman, W.M., Pardalos, P.M., Principe, J.C., and Carney, P.R., Effects of acute hippocampal stimulation on EEG dynamics. Proceedings of the 28th IEEE EMBS Conference, New York, New York: pp. 4382-4386, 2006.

6.Shiau, D.S., Nair, S.P., Iasemidis, L.D., Carney, P.R., Norman, W.M., Principe, J.C., Pardalos, P.M., Suharitdamrong, W., Cho, J., Sackellares, J.C., Seizure warning and dynamic response to electrical stimulation in a rodent model of chronic limbic epilepsy. in IFMBE Proceedings of 3rd European Medical and Biological Conference, Prague, Czech Republic: Vol. 11, 2005.

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