Gurjaap Bindra
Sr. Clinical Scientist at Regeneron Pharmaceuticals, Inc.- Claim this Profile
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English -
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Punjabi -
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Hindi -
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French -
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Urdu -
Topline Score
Bio
Experience
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Regeneron
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United States
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Biotechnology
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700 & Above Employee
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Sr. Clinical Scientist
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Feb 2020 - Present
PROFESSIONAL EXPERIENCE Regeneron Pharamceuticals Sr. Clinical Scientist Feb 2020- Present • Support clinical oncology study teams with analysis of trends, safety and efficacy, quality check clinical data periodically and query issues • Review study related documents such as data management plan, eCRF completion guidelines, data validation manuals, database UAT • Draft and review clinical sections in regulatory and clinical documents such as study protocols, DSUR, investigator’s brochure, PIP application, conference abstracts, slides for presentation • Authored an Expanded Synopsis for a Pediatric oncology study with the Medical director. • By collaborating with interdisciplinary teams, develop and optimize REGN’s indication knowledge base/dashboard to facilitate information sharing across the organization. Show less
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Idera Pharmaceuticals
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United States
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Biotechnology Research
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1 - 100 Employee
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Clinical Research Scientist
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Sep 2018 - Feb 2020
• Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification) • Utilizing RECIST v1.1 for the Efficacy analysis on a phase 1 and phase 2 solid tumors study. • Successfully planned execution of deliverables with the clinical team along with the vendors to conduct Data base lock activities for the phase 1 monotherapy safety/dose evaluation study and phase 2 combination study • Provide internal communication of important clinical data and events for press releases. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders • Work cross-functionally with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents • Escalate key study-level issues requiring expert medical input to Clinicians on an as needed basis • Authored clinical study reports; Informed Consent Forms (ICF), protocols, Investigator brochure and Summary of Changes • Provide scientific input and review of protocol violation and deviation data, support in assessing medical monitoring reports, study integrity/conduct and protocol oversight. • Conducting meetings with Data management and the vendors to ensure query resolution • Contributing to Study start up, site selection, and design for a Colorectal Cancer trial. • Proficient in Using Medidata Rave and J-review to perform in depth analysis of trends and listings. • Heavily involved in authorship of a phase 1 Poster presentation Show less
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Celgene
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Research Scientist
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Jun 2016 - Jul 2018
• Contribute to design, analysis, interpretation and reporting of scientific content of protocols, investigator Brochures, Clinical Study Reports in a Phase 3 study for AML • Performed patient data review using patient profiles, data listings, and J-review. • Review and perform trend analysis for Protocol Violations/ Deviations • Manage and facilitate monthly Clinical Data Review Plan meetings • Trained and managed fellow’s and interns with Study procedures and processes. • Implemented Data Lock meetings • Prepared slide decks for Data Monitoring Committee (DMC). • Vendor management Show less
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Classic SuperPetrol Inc.
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Feasterville, PA
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Manager
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Jan 2012 - Jun 2016
• Perform daily duties supervising and managing the employees as well as meeting with clients • Place orders for inventory of products within the store and Gas • Manage the finances of a Gas Station business • Perform daily duties supervising and managing the employees as well as meeting with clients • Place orders for inventory of products within the store and Gas • Manage the finances of a Gas Station business
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Physiology and Pharmacology Research
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Drexel University
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Research Assistant
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Aug 2014 - Jun 2015
• Performed experiments with Drosophila melanogaster’s IFM muscles regarding the ion channel mutations • Utilized dissection, microscopic, pipetting techniques and used J-image to perform analysis of dissected mitochondria • Gathered data on an experiment for a poster presentation to the Biophysical Society in February 2015 • Performed analysis becoming a co-author of an accepted Abstract for the Biophysical Society • Performed experiments with Drosophila melanogaster’s IFM muscles regarding the ion channel mutations • Utilized dissection, microscopic, pipetting techniques and used J-image to perform analysis of dissected mitochondria • Gathered data on an experiment for a poster presentation to the Biophysical Society in February 2015 • Performed analysis becoming a co-author of an accepted Abstract for the Biophysical Society
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Axera
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Mexico
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Retail
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200 - 300 Employee
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Sales Associate
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Jan 2015 - May 2015
• Consulted customers to a healthier lifestyle by informing about diet, exercise and beneficial store supplements • Sold products in order to increase sales of the overall store • Utilized GNC handbooks and School Knowledge to inform customers the positives and negatives of product usage • Consulted customers to a healthier lifestyle by informing about diet, exercise and beneficial store supplements • Sold products in order to increase sales of the overall store • Utilized GNC handbooks and School Knowledge to inform customers the positives and negatives of product usage
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Knights Medical Associates
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Bensalem, PA
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Assistant Manager
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Apr 2007 - Jun 2012
• Served as a customer service representative and conveyed information according to the medical office's policy • Answered questions for patients concerning billing, appointment schedules, prescription refills, and medical insurance • Completed billing forms, blood testing requests, and patients' referrals to other medical facilities • Served as a customer service representative and conveyed information according to the medical office's policy • Answered questions for patients concerning billing, appointment schedules, prescription refills, and medical insurance • Completed billing forms, blood testing requests, and patients' referrals to other medical facilities
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I.C. Laser Eye Care
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Bensalem, PA
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Intern
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Sep 2009 - Sep 2010
• Facilitated the care of patients during the pre-examination phase, paperwork and assisting them to the examination room • Consulted patients with any concerns that the doctor would need to address • Supported physician during examinations through retrieving eye drops, contact solution and lenses • Assisted patients with questions post examination and distributed sample medications as directed by doctor • Facilitated the care of patients during the pre-examination phase, paperwork and assisting them to the examination room • Consulted patients with any concerns that the doctor would need to address • Supported physician during examinations through retrieving eye drops, contact solution and lenses • Assisted patients with questions post examination and distributed sample medications as directed by doctor
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Education
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Drexel University
Bachelor of Science (B.S.), Psychology -
Mercer County Community College
Clinical and Industrial Drug Development -
Drexel University
Master's degree, Science