Project Manager Development
Resume:
Suganthy Yoganathan
E-mail: ********@*******.***
Clinton NJ 08809
CAREER OBJECTIVE:
To join a highly reputed and professional clinical research work environment and apply my experience and knowledge can contribute to the growth of the organization and demonstrate problem solving and team building skills.
SUMMARY
• Extensive years of clinical research experiences with team leadership and problem-solving capabilities
• Excellent oral communication skills with extensive years of medical/scientific writing experience
• Participate in all aspects of clinical development and study management
• Responsible for biomarker protocol development, study design, management and implementation
• Expertise in oncology therapeutic area and extensive knowledge in medical and safety data review, data management, CRF design, SAE and Adverse Events evaluation and reconciliation.
• Thorough understanding of data management with vast work experience in oncology clinical R&D genomics functional screening and GMP manufacturing in bio-pharmaceutical industry with various positions of increasing responsibility within complex matrix organization
EXPERIENCE
2002-March 2011:
Research Scientist
Bristol-Myers Squibb –Hopewell NJ
Member of the Translational Oncology biomarker group. Manage and Key player for the discovery of Pharmacogenomic and Pharmacodynamic (PD) biomarkers to assist in the clinical development of several investigational oncology compounds in Phase1, II, III,IIIB and IV clinical trials in Bristol Myers Squibb’s oncology portfolio.
Leading/ Managing/ Collaborating Skills
• Project manager for XL 184 program and incorporated biomarker Strategies and writing into Clinical Protocols where applicable.
• Draft study synopsis ,protocol and Create monitoring plan and informed consent, provide input on CRF design obtain key opinions from DMCP, act as a liaison between project team and DMCP. Compose abstracts, manuscripts and clinical findings
• Develop certain sections of Investigator’s Brochure, Briefing Book, IND annual book, IND and clinical study report
• Responsible for all operational activities for biomarker in clinical trial under the leadership of clinical trial director.
• Interpret data arising from studies and assess potential consequences for development program Communicate findings to sub-team, and clinical development team .
• Provide scientific input to the development of contingencies, where the emerging data require changes to the program and individual studies. Implement the amended program of work in accordance with a revised Clinical Development Plan Provision of scientific input into program design.
• Track and manage studies to agreed timeline, budget and resource, highlighting significant variances to the study team.
• Monitor study progress and worked closely with clinical operational teams and functional groups to develop the protocol with the standards of GCP and with all applicable regulatory requirements by providing for biomarker sample collections on regarding the genomics/genetics and biomarker assay development. Coordinating of all biomarker assays - development, analytical validation and sample analysis. Train internal and external study personnel in study specific procedures.
• Familiarity with CROs and other companies for routine outsourcing of assay work domestically and internationally and providing recent scientific updates, novel technology applications, and guidance.
• Forecast timelines, budget, materials and resource for a defined component of the biomarker clinical development program and Keep tract of the budget within oncology late stage products as well as in the managing of external collaboration and clinical operations.
• Project leader for preclinical studies to discover potential biomarkers that could be used to differentiate our VEGFR-2 inhibitor from the competition and better understand the mechanism of action (MOA). This work led to initiate the phase II clinical study and several collaborations internally and outside the BMS including with Dr. Hanahan at UCSF to study our VEGFR-2 inhibitor in a VGFR-2 resistant preclinical model and better understand the pathways involved with VEGF and FGF signaling and publications.
• Responsible for clinical genomic data management, contributions to scientific manuscripts, presentations and project updates to medical and management personnel.
• Explore new opportunities for technology development/expansion and Point of Contact for collaborators from other companies developing supportive technologies.
• Remain current with literature, novel and new technologies and share knowledge with discovery, clinical and commercial colleagues through presentations and written reports.
• Assist the drug discovery group in use of biomarkers for lead therapeutic candidates to develop pharmacogenomic and pharmacodynamic assays.
• Perform extensive data and statistical analysis from gene expression data to identify genomic markers predictive of drug response and identification of new drug targets in different cancer by treatments comparison, classification algorithms, hierarchal clustering, gene pathway and clinical data analysis.
• Generate expression profiles from preclinical and clinical diagnostic tumor specimens using Affymetrix gene chips. Performed RNA isolation , RT-PCR,
• Perform cells based assay with cancer cell lines for biomarker discovery.
• Tailored screening strategies using siRNA, Phospho- ELISA, FACS and immunoblot and immuno-precipitation techniques to study the protein expression with drug in cancer cell lines.
Communication/Organizational Skills:
• Key interface to “bridge” the silos between Discovery and Clinical, and transitioning compounds beyond Early to Full development and Life cycle Management teams -including Served as liaison between sponsor, investigators, management and research personnel.
• Biomarker strategic leader in XL-184 program as well as in managing external collaborations for Brivanib program.
• Prepared and sent post 4.5 programs cost metrics for senior managers every end of the quarter
• Researched and developed new methods/techniques and wrote SOP’s. Present the data to group meeting, Biomarker working Group meetings, medical and management personnel.
COMPUTER SKILLS:
• MS Excel, MS Power Point, MS Word, programming in Basic, Gene cluster, spotfire, Waters Millenium software, FACTS, GEMINI, multimekpro, cybio control, softmax, image pro plus, cell quest, Origin, and Graphpad Array Studio .
• Experience with assessing and searching scientific databases and sequence analysis software
LAB SKILLS:
• Cloning and subcloning, RT-PCR techniques, siRNA screening, Microarray, cDNA and genomic library construction and screening, protein expression.
• Animal tissue culture, isolation of specific cell using FACS, immunofluorescent assay and isolation of white blood cells.
• High throughput screening:
Used TECAN, Beckman multimeck automated 96-channel pipetter, Platemate automated pipetter, Titertek automated pipetter and Topcounter scintillator.
Oct 2001-Aug2002
Associate Scientist
Bristol-Myers Squibb- Lawrenceville NJ.
Member of the discovery biology group. Responsible for and optimization of the cytotoxicity assay development
• Maintained cell lines and performed cell based assays.
• Designed and performed assays and implemented high throughput screening protocols to recover targeted cytotoxic concentration
Dec 2000-Sep 2001
Scientist
Roche Molecular Systems, Belleville, NJ.
Member of the research and development group. Contributed in a team environment to supply high quality oligonucleotides in support of GMP manufacturing of diagnostic PCR products.
• Developed and optimized methods of purification and analyses.
• Purified and analyzed oligonucleotides by HPLC.
• Maintained and trouble shoot HPLC instruments.
• Responsible for writing and editing standard operating procedures (SOPs) used in the R&D group.
June 2000-December 2000
Research Scientist
Roche Vitamins, Inc, Nutley, NJ.
Member of the research and development group. Contributed to the discovery and development of substitute growth hormones from natural Products.
• Maintained cell lines and performed stable cell transfections.
• Selected stable cell lines using FACS, immuno-fluorescence microscopy and immuno-precipitation.
• Designed and performed assays and implemented high throughput screening protocols to recover targeted natural products.
March 2000-June 2000
Research Scientist
CELGRO Corp, North Brunswick, NJ.
Member of the research and development group. Contributed to the discovery and development of novel enzymes for applications in bio-transformation reactions.
• Designed and implemented enrichment, isolation, and high throughput screening protocols to recover targeted enzymes.
• Conducted biochemical studies to assess the productivity of recombinant fermentation processes of microorganisms.
• Operated and maintained lab-scale fomenters.
• Contributed to the scale-up of recombinant fermentation processes
1998-2000 March
Research Assistant
Department of Chemistry, Washington State University.
Investigated the immuno-response of macrophages by studying the reactive oxidants produced by activated murine macrophages.
• Cultured primary and transfected cell lines.
• Activated the cells and analyzed products by uv-vis spectrophotometry, liquid scintillation counting, and HPLC and fluorescence spectrophotometry.
• Synthesized polyacrylamide beads as mimic bacteria and observed phagocytosis.
• Used scanning electron microscope and fluorescence microscope to characterize polyacrylamide beads.
1997-1998
Teaching Assistant
Undergraduate Organic Chemistry, Washington State University.
• Planned and led help sessions and recitations in organic chemistry.
• Conducted lab sessions and graded lab reports.
EDUCATION
May 2000 MS (Chemistry), Washington State University, Pullman, WA.
August 1997 BS (Biological science), Ohio State University, Columbus, OH.
Clinical and Drug development process Skills:
June 2011 Certificate in Drug Development & Clinical Research,
Mercer County Community College/New Jersey.
Core courses attended in this program include:
• Foundations of Clinical Research and Study Design Course
- Course projects included: developing an ICF, writing a clinical trial Protocol writing and amendment/presenting to investigators and conducting a mock trial.
• Regulatory and Legal Issues Course
-Class project presenting to a Mock Advisory Committee
• Data Management/Biostatistics
-Individual project design and develop a CRF
March 2006 Pharmaceutical Education &Research Institute, Inc (PERI)
Certificate: Concepts in Good Clinical Practices for the clinical Research
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