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Project Management

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Posted:
February 20, 2018

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SUMMARY

Highly accomplished Clinical Research Professional and a certified PMP, with 8+ years of experience, merging scientific research foundation with Business,Financial & ProjectManagement strengths.

Directed and executed a broad array of technology-based and strategic operational advisory projects in Healthcare, Pharma & Biotechnology, Stem cell research, and Diagnostics, managing client expectations and operational goals.

Designed and implemented structured project management methodologies for the project management practice, and developed successful project dashboard templates for effective execution of project plans, resource allocation and processes improvements.

Identified and implemented innovative solutions to turn-around failing projects. Directed 16+ projects, producing consistent, quality results and stringent cost controls, while leading teams of 75+.

Experience

Project Management & Technology Consultant. June 2017–Present

Clients:

Gut Health Lab, Department of Veterinary & Biomedical Sciences

South Dakota State University, Brookings, USA.

Developing Quality Management Systems and Project Metrics, Preparing Invention Disclosures, Planning Clinical Trial Budget & Clinical Trial Site Identification.

Faculty, Henry Ford College, MI, USA. Jan 2017–May 2017

Program Leadership history

Founder and Director

SVK Healthcare & Life Sciences Pvt. Ltd., 2008 – Dec 2016

A global Pharma & Biotech Clinical Research / Project Management Consulting.

Key Projects:

Immuno-Diagnostic Assay Design / Development and Testing studies for the diagnosis of P falciparum and vivax Malaria.

Directed cross-functional teams through project Life cycle in developing the Immuno- diagnostic kits and ensured the best of quality in establishing the sensitivity and specificity of the diagnostics.

Established clinical study objectives, strategy, budget, prepared and monitored clinical Investigational Plans.

Established study milestones and ensured accurate tracking and reporting of study metrics.

Successfully implemented the project management methodologies like Earned value management techniques (EVM) in completing the project on time, scope and budget.

Product Launch and Marketing of Diagnostic services and Stem cell banking services, in the South Indian Market.

Clients: Diagno Labs India & Cryobanks International

Financial Oversight: Held high level fiduciary responsibility as a marketing partner for the above clients, exceeding 100% of the goals.

Directed project management teams in Strategic Planning, Pre-and Post-Launch activities, Value proposition development, administrative and budgeting process.

Directed a matrixed, cross-functional team, liaised with marketing, sales, training, and clients (HCP’s & Consumers) and monitored the interdepartmental facilitation of information.

Defined and ensured attainment of project deliverables, created and executed project plans, and facilitated communication between project stake holders.

Tracked expenditures, controlled multi-million-dollar operating budget, planned and organized project logistics.

Margin Improvement: Boosted profits of $ 3M in a record span of 18 months and responsible for capturing 40% of the Market share.

Client Satisfaction: Raised customer satisfaction by 70% through constant communication, commended for capturing huge market share in a short time.

Clinical research / studies, for developing and standardizing therapeutic procedures to treat severe burns, and wound healing in diabetics, using Mesenchymal stem cells.

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Lead the development, management and implementation of organization's research and development policies, objectives, and initiatives and ensure deliverables on time during development of Stem cell therapeutic procedures.

Directed and monitored clinical research Managers / Staff and conducted training. Organized and conducted Investigator and Safety Monitoring Board meetings.

Developed and oversee budgets and policies and procedures for the Research Department.

Built effective and strategic physician / vendor relationships by representing the company to Key Opinion Leaders (KOL), clinical investigators and Scientific thought leaders.

Developed strong understanding of global health care systems and built strategic relationships with external Health Care Technology Assessment bodies to garner insights into therapeutic development process.

Provided disease management studies and outcomes studies for pharmaceutical companies.

Assured compliance standards with all applicable ICH/GCP, IRB/IEC parameters, and SOPs.

Coordinated with key stakeholders and research and development team and made recommendations based on research findings and project performance, to ensure stakeholders satisfaction.

Children’s Hospital, Los Angeles, CA, USA. 2006 – 2007

Postdoctoral Fellow – Division of Infectious Diseases

Designed and conducted research to study Enterobacter sakazakii and its invasion of human brain microvascular endothelial cells. Enhanced the understanding of the complex molecules of the Cronobacter Sp. involved in human infection and disease progression.

The understanding of the pathogenesis of infection is crucial to the development of innovative and effective therapeutic strategies for several diseases like neonatal meningitis in newborn babies.

Presented research findings at high profile international and national conferences.

Trained and supervised students and lab technicians on day-to-day lab operations.

Birla Institute of Technology and Science, Center for Biotechnology, Pilani, India 2000 – 2006

Doctoral Researcher – Clinical Microbiology & Immunology

Designed, conducted, and analyzed research studies in the area of Malaria research, focused on addressing a global health concern.

The project studied the antibody response in naturally infected population from different regions of India. Peptides delineating linear epitopes from four different reported MSP-119 alleles were used to analyze the antibody profiles of 35 P. falciparum infected patients from eastern, western, and southern India. Initial findings suggested there is a cross reactivity among different alleles in humans and mice. The data could be of use in designing effective MSP-119 peptide based vaccine against malaria.

Research is cited in the 2014 Yellow book published by CDC, Atlanta.

Initiated a research collaboration with the WHO Center for Measles in Luxembourg.

Presented research findings at high profile scientific conferences and meetings.

Compiled, analyzed, and published study findings.

Instructor for Biological Sciences Group; taught courses for graduate and undergraduate students.

Dr. Reddy’s Laboratories Ltd., Dept. of Biotechnology, Hyderabad, India 1999 – 2000

Research Associate - Indian Government Training Program

Developed Indigenous Immuno Diagnostic Kits for HIV & Hepatitis–B.

Pasteur Institute of India, Coonoor, India. 1998

Trained in Vaccine Production (Down stream Processing)

Education & Professional Development

Ph.D., Molecular Biology & Immunology, 2006

Birla Institute of Technology and Science (BITS), Center for Biotechnology, Pilani, India

Master of Science, Biotechnology, 1999

Nagarjuna University, Guntur, India

Bachelor of Science, Botany, Zoology & Chemistry, 1996

Nagarjuna University, Guntur, India

Financial Modelling & Valuation, New York School of Finance, NY, USA., 2017.

Awards & Fellowships

NIH Fellowship towards Post-Doctoral training at Children’s Hospital Los Angeles, University of Southern California, Los Angeles, 2006 – 2007.

Senior and Junior Research Fellowship by BITS, Pilani, India, 2002 – 2005 and 2000 – 2001.

Ministry of Co-operation Fellowship by Govt. of Luxembourg, Europe, May 2001.

Ministry of Science and Technology, Govt. of India Fellowship facilitated through Biotech Consortium India LTD (BCIL), for post M.Sc. Industrial Training at Dr. Reddy’s Laboratories, Hyderabad, India, September 1999 – March 2000.

Journal Reviewer

Acta Parasitologica, Poland (Springer Publications)

Research and Special Articles (International Journal of Biomedical Research), India

Journal Affiliations

Editorial / Advisory Board Member - International Journal of Biomedical Research, an international peer reviewed journal, India

Editorial / Advisory Board Member - International Journal of Advances in Scientific Research, peer reviewed open access multidisciplinary journal, India.

Publications

Vijay K. Singamsetty, Ying Wang, Hiroyuki Shimada, Nemani V. Prasadarao. “Outer membrane protein A expression in Enterobacter sakazakii is required to induce microtubule condensation in human brain microvascular endothelial cells for invasion.” Microb Pathog. 2008 Jun 3.

Catherine J. Hunter, Vijay K. Singamsetty, Nikunj K. Chokshi, Patricia Boyle, Victoria Camerini, Anatoly V. Grishin, Jeffrey S. Upperman, Henri R. Ford, and Nemani V. Prasadarao. “Enterobacter sakazakii Enhances Epithelial Cell Injury by Inducing Apoptosis in a Rat Model of Necrotizing Enterocolitis.” J Infect Dis. 2008 Jun 27.

Vidya Rajesh, Vijay Kumar Singamsetti, S. Vidya, M. Gowrishankar, M. Elamaran, Jyotsna Tripathi, N.B. Radhika, Dhanpat Kochar, Akash Ranjan, S.K. Roy, Ashis Das. “Plasmodium falciparum: Genetic Polymorphism in Apical Membrane Antigen – 1 gene from Indian Isolates”, Experimental Parasitology – 119 (2008) 144-51.

Catherine J. Hunter, Vijay K. Singamsetty, Victoria Camerini, Jeffrey S. Upperman, Nemani V. Prasadarao, and Henri R. Ford. “Enterobacter sakazakii induces necrotizing enterocolitis (NEC) in vivo by upregulating enterocyte IL-6 production”. Journal of the American College of Surgeons. September 2007, Volume 205. (Abstract).

Vijay K. Singamsetty, Vishal Saxena, Shilpi Garg, SK Roy, Dhanpat Kochar, Annie Albin, R.P.Pareekh and Ashis K. Das. “Plasmodium falciparum merozoite surface protein 119 (MSP-119) – Humoral responses to allele specific variants from India.” (Manuscript in Preparation).

Vijaya Kumar Singamsetty., March 2006. “Studies on Sequence Diversity and Characterization of the Cysteine Rich Carboxy Terminal Region of Merozoite Surface Protein – 1 (MSP-1) of P. falciparum in Indian Isolates.” (Doctoral Thesis).

S. Vijay Kumar, Sarita Ranjan, Vishal Saxena, Vidya Rajesh, SK Roy, Dhanpat Kochar, Akash Ranjan and Ashis Das. September 2005. “Plasmodium falciparum: Genetic Diversity of C- terminal region of MSP-1 in isolates from Indian Sub-Continent.” Experimental Parasitology 110 P. 384-388.

Dhanpat K. Kochar, Vishal S, Narvachan Singh, Sanjay K. Kochar, S. Vijay Kumar and Ashis Das. January 2005. “Plasmodium vivax Malaria.” Emerging Infectious Diseases. Vol.11, No. 1. P.132 – 134.

Presentations

V.K. Singamsetty, and P.V. Nemani. “Enterobacter sakazakii invasion of Human Brain Microvascular Endothelial Cells Requires Microtubule Polymerization and Activation of PI3- Kinase.” 107th ASM General Meeting, Toronto, Canada (2007).

Kumar VS., Saxena V., Garg S., Roy S., Kochar D. K., Albin A., Pareekh RP., Das A., “Plasmodium falciparum merozoite surface protein 119 (MSP-119) - humoral responses to allele specific variants from India”, International Conference on Malaria, National Institute of Malaria (MRC) and ICMR, New Delhi, Nov. 3-5, 2005.

Ashis K. Das, Vijay Kumar S. “Polymorphism in MSP1, a leading vaccine candidate antigen of Plasmodium falciparum.” International Symposium and CME on Modern Trends in Malaria, All India Institute of Medical Sciences, New Delhi, January 2003.

Vijay Kumar S. “Merozoite Surface Protein -1 of Plasmodium falciparum, its implications in vaccine design.” International Symposium on Emerging Trends in Genomics and Proteomics Education and Research. Jan 12 & 13, 2003, Pilani, India. Organized by Uniformed Services University of Health Sciences (USUHS), Bethesda, Maryland.

Vijaya Kumar S, Ashis K. Das. “Polymorphism in MSP-1, a leading vaccine candidate antigen of malarial parasite”3rd EMBL PhD student Symposium “Life within Boundaries: Membranes and Compartments in Biology”at EMBL, Heidelberg, Germany (14th – 16th Nov., 2002).



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