Medical Clinical

JAGVEER SINGH, PhD MBA

**** ****** *** *****, ***********, MD 21029 Phone: 443-***-**** Email: **********@*****.***

PROFILE

Experience with leadership in managing projects and teams in clinical research, healthcare, and medical research; proficient in asset (policy, process, personnel) enhancement, systems implementation in key operational areas of capacity utilization, revenue cycle management, and productivity increase; published original research in peer-reviewed high impact journals as principal author; written research grants, business plans, clinical protocols, SOPs, manuscripts, patent applications; effective and result-driven in integrating and summarizing medical and scientific concepts in clinical documents for regulatory submissions; persuasive communication skills with thorough understanding of FDA and international regulatory requirements (21 CFR, MEDDEV 2.7.1 v4) with extensive knowledge of ICH E6 R2 (GCP), ICH E3, and GPP3; founding President Johns Hopkins Business Finance Club, Contributing member of American Medical Writers Association (AMWA).

EDUCATION

MBA Finance

Johns Hopkins University, Baltimore, MD

Ph. D. Molecular Biology

All India Institute of Medical Sciences, New Delhi, India

Master of Science Biochemistry

Aligarh University, India

Bachelor of Science Chemistry (Honors)

Aligarh University, India

WORK EXPERIENCE

Senior Manager, Medical Communications Sept 2017-Present

National Cancer Institute, NIH, Bethesda, MD

Responsible for serving as strategic advisor to various leaders and staff in NCI’s Divisions, Offices, and Centers (DOC) for effective communication strategies and tactics to support Office of Communications and Public Liaison’s (OCPL) communications initiatives.

Plan, develop, and implement innovative strategic communications plans to communicate information about cancer research initiatives and public health issues to ensure that new discoveries, clinical trials, and NCI research initiatives are disseminated to NCI audience; researchers, health professionals, cancer related organizations and associations, cancer advocacy groups, Congress and other federal government health officials, and the public, as appropriate.

Function as Communications Lead to clarify and define new projects that come to OCPL, work across OCPL’s three offices with various staff members, manage project timing, next steps and coordinate NCI launches.

Consultant, Translational writing (Per Diem, Remote) Jun 2017- Present

Kite Pharma, Inc. Santa Monica, CA

Responsible for supporting strategic communications and regulatory submission cross functional teams in clinical and translational development life cycle of CART cells based therapeutics for multiple myeloma, lymphomas and other hematologic malignancies.

Responsible for supporting medical affairs functions by preparing clinical protocols, clinical reports, and integrated summaries (CTD Modules, clinical overviews) in line with Company and in compliance with regulatory requirements.

Write non-clinical and preclinical scientific and technical reports for GLP translational studies conducted by CROs.

Work independently and with stakeholders to prepare scientific summaries, regulatory documents and submissions, including: nonclinical summaries for IND, NDA, and CTA applications to Health Authorities, Investigator Brochures, product monographs/package inserts, and responses to health authorities.

Review data to determine the appropriate tabular and textual formats for clarity, logic and order of presentation.

Create materials for publications (summaries, posters, manuscripts, presentations) in conjunction with other stakeholders for internal and external meetings and conferences.

Serve as an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.

Contribute to authoring, review, and approval process for documents within an electronic publishing system and electronic document management system.

Consultant, Medical Communications (Per Diem, Remote) May 2017- Present

Impact Journals LLC, Orchard park, NY

Responsible for editing and quality control functions in publishing scientific articles in oncology and cancer research

Correct grammatical errors, revise vague or awkwardly constructed sentences so that they express the ideas of the authors accurately in clear and concise language in adherence to the journal style.

Write peer-to-public (layperson use) executive summaries of high impact hard science original research articles published in Oncotarget.

Senior Manager, Medical Affairs Jun 2016-Jun 29, 2017

Roche Molecular Diagnostics, Pleasanton, CA

Responsible for supporting clinical product development teams and clinical operations teams in Genomics, next generation sequencing (NGS), Oncology, Virology (including HPV, HIV, CMV), Microbiology, and Blood screening for Zika, Babesia, MRSA, and HPV as a medical writer producing clinical documents in common technical format as per FDA and ICH Guidelines.

Responsible for supporting medical affairs functions by preparing clinical protocols, clinical reports, and integrated summaries (CTD Modules 2-5, clinical overviews) in line with Company and in compliance with regulatory requirements.

Responsible for developing submission-ready clinical regulatory documents (CVPs, CSRs, CERs, Protocols, clinical utility, and clinical reproducibility) and managing contents in SharePoint.

Work closely with KOLs, medical affairs and clinical operations leads and other stakeholders in strategic planning and execution (timeline, budget).

Responsible for developing and tracking project plans, milestones and deliverables; reviewing, editing, authenticating and quality assurance in submission-ready regulatory publication (INDs, IMPDs, IDEs, 510k, BLA, MAA, PMA, NDA and Post approval updates, PSURs, DSURs); authenticating clinical document (Protocols, Case report Forms, Investigator Brochures, Informed consents, Financial disclosures in CTD/eCTD as per ICH/GCP guidelines) in SharePoint.

Responsible for searching literature from database such as PubMed, Medline, EMBASE, researching, analyzing source documents and data, writing manuscripts as per GPP3, ICMJE and ISMPP guidelines, and strategic publications planning in Datavision (DV).

Responsible for creating and maintaining References and Bibliography using EndNote.

Responsible for managing vendors and offshore team of document development and medical writers, quality control, quality assurance, authentication of work of others, and deliverables.

Professional level proficiency in Microsoft office applications (word, excel, power point), EndNote, Adobe Pro, Adobe FrameMaker, Electronic document management system (EDMS), Project management (MS PMP, PMBOK).

Train-The-Trainer - Responsible for coaching and mentoring medical writers in developing submission-ready regulatory documents.

Consultant, Medical Affairs (Per Diem, Remote) Sept 2016-May 2017

Human Longevity Inc., San Diego, CA

Prepared clinical evaluation/validation documents for submission to FDA for CLIA approval of next generation sequencing (NGS) based precision diagnostic. I manage all the contents in SharePoint and manuscripts for publication in Datavision.

Clinical Project Manager/Clinical Operations Nov 2015-Jun 2016

Maryland Heart Associates, Glen Burnie, Maryland

Responsible to drive policy and procedural changes, develop cross-functional project plans, develop measurement criteria, conduct work flow analysis, assess departmental performance, develop communication plans with internal and external stakeholders, implement metrics and end-to-end process reviews, conduct project updates, train team members, serve as a liaison on best practices, process improvement, and systems implementation in key operational areas of capacity utilization, revenue cycle management, & productivity increase.

Successfully led the acquisition and implementation of a new clinical operations/trial management system (CTMS) to manage center wide clinical research activities in coronary heart disease, inventory management system and vendor management.

Developed clinical operations plans, wrote protocols, and clinical reports (CSR, CER) on circulatory systems (cardiovascular) in SharePoint.

Proficiently used Office 365 and Adobe Pro for creating contents of clinical documents as per GCP and ICH guidelines and managed all contents SharePoint.

Managed clinical practice of 6 intervention cardiologists, vendors and suppliers.

Performed medical and clinical literature reviews using PRISMA and PubMed to determine current status of clinical evaluation reports (CER, MEDDEV 2.7.1 Rev4) and other documents supported by clinical evaluations and management (E/M) in SharePoint.

Analyzed clinical data of past 10 years using PRISMA/PubMed, Medline, EMBASE to identify trends and knowledge gaps using structured analytic tools such as Pub-med, PRISMA, Medline, and wrote manuscript for publication in American Journal of Cardiology and other peer reviewed journals.

Created infomercials and other medical contents for public education and professional use.

Analyzed clinical data to assess for its relevance to incorporate into the CER, CSR, and manuscripts as per GPP3 guidelines and procedural requirements of GPO, AP-, and AMA-Style, Managed references and bibliography using EndNote.

Retrieved and disseminated pertinent literature data from Medline and Pub Med and PRISMA as needed.

Streamlined work flow and division of labor, improved quality, eliminated waste, reduced cycle time, enhanced practice finances, standardized routine tasks and administrative functions, adjusted staff level to match projected work-load, and conducted assessments (SWOT Analysis)

Strategic Financial management- Vertically integrated patient registration with billing and collection procedures to maximize revenue realization, minimize accounts receivables, and strengthen internal controls, managed budgets for equipment, payrolls, consumables, perishables, disposables, and miscellaneous items.

Clinical Project Manager/Clinical Operations Dec 2014 –Jun 2015

University of Maryland School of Medicine/ Dept. of vascular Surgery, Baltimore, Maryland

Responsible for planning and implementing robust regulatory and strategic management (financial as well as administrative) activities from clinical study start-up through study progression. I managed the clinical and research operations of five clinical studies on carotid stenosis and peripheral vascular/arterial occlusive disease, and CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) Clinical Trial Companion Registry.

Actively involved in the planning and execution of cardiovascular clinical trial operations in CTMS, budgeting, preparing grant applications, writing clinical protocols, clinical study reports and other clinical documents in CTD/eCDT format in SharePoint, publication manuscript preparation in Datavision for multiple clinical studies in cardiovascular program.

Contributed to the overall strategic vision and leadership and managed projects and objectives by designing, planning, driving meetings and agendas, tracking, forecasts, and providing updates to executive committee and steering committee.

Responsible for supporting medical affairs functions by preparing clinical protocols, clinical reports, and integrated summaries (CTD Modules, clinical overviews) in line with Company and in compliance with regulatory requirements.

Created and managed budgets for personnel (administrative staff and clinical research teams), capital expenditure (equipment and machines), service contracts, consumables, perishables, disposables and miscellaneous items to compete for new grants to Government (NIH, FDA) and private industry (Pfizer, Merck, Abbott Vascular, Medtronic, Covidien, J&J, Silk Road Medical, Boston Scientific) in Excel.

Employed management tools of PMBOK and Six Sigma for project management and implementation.

Strategically allocated funds to develop clinical trial (CREST-2) registry infrastructure and setting up new office for new hires, consultants and advisors, managed vendors, purchased equipment, computers, IT software and other necessities in Excel.

Designed protocols and developed procedures for establishing clinical trials (CREST-2) Registry (C2R), assisted in development and maintenance of SOPs, templates and style manuals in common technical document (CTD/eCTD) formats in SharePoint.

Performed medical and clinical literature reviews using PRISMA and Pub-med to determine current status of clinical evaluation reports (CER, MEDDEV 2.7.1 Rev4) and other documents supported by clinical evaluations and management (E/M).

Analyzed clinical data, reviewed literature from database such as PubMed, Medline, EMBASE to identify scientific trends and knowledge gaps and incorporated into the Clinical Study Reports (CSR), and manuscripts as per established GPP3 guidelines and procedural requirements of GPO, AP and AMA, managed references and bibliography using EndNote.

Conducted due diligence for approval and registration of participating clinical centers and physicians.

Prepared Manual of operations; wrote program protocols, grants for funding, news/press releases and research articles.

Retrieved and disseminated pertinent literature data from Medline, Pub Med, and EMBASE database as needed.

Organized, scheduled and conducted all activities of C2R; prepared meeting minutes, agenda items and highlighted actions items for conference calls of the Management Committee and Steering Committee, conducted project meetings and prepared press releases.

Reconciled revenue recognition cycle with incurring and recurring (such as payroll and service contracts for machines and equipment) expenditure (in a constantly changing funding environment) on a monthly basis using INSIGHTS ERP modules and Excel.

Managed partnerships with consortium and program members, interacted with various registries and developed database for the study.

Raised funds, managed budgets and business relationships with sponsors, funding agencies and clinical centers/service providers. Managed department strategic projects and objectives by designing, planning, driving meetings and agendas, tracking, forecasts, and providing updates to executive management

Scientific and Medical Writer Dec 2004 –Nov 2014

NIH, FDA, Dept. of Education, Bethesda Maryland

Provided scientific and management services to National Institutes of Health, National Cancer Institute, NHLBI, FDA, and Department of Education.

Conducted business intelligence and gap analysis for establishing Biorepositories and Bio-specimen research program at NIH.

Provided hands-on leadership on stocking, inventorying, electronic data capture, and bio-specimen data management.

Compiled complete, concise and accurate (white paper) report on the current status of biorepository standards.

Attended meetings at NIH, FDA and Department of Education, to review progress reports, develop outreach strategies, and formulate performance evaluation matrix.

Reviewed literature from database such as PubMed, Medline, EMBASE, wrote scientific manuscripts as per GPP guideline, managed references and bibliography using EndNote, standard operating procedures, manuals and technical reports in SharePoint.

Director of Technical Communications Apr 2002 – Nov 2004

Nova Screen Bioscience Corp, Hanover, Maryland

Prepared and administered federal grants and contracts, wrote business and commercialization plans, managed intellectual property and client contracts, prepared patent applications, and implemented QA/QC.

Developed and implemented robust improvement process to support in house and outsourced clinical biomarker assay development.

Provided oversight of all aspects of contract research studies involving In vitro oncology biomarker testing kits.

Proficiently used Office 365 with SharePoint for all the content management, business intelligence and business solutions.

Prepared manuals and SOPs to manage in vitro assays in Neurosciences, Cardiovascular and Oncology portfolios.

Provided oversight and coordinated operations of internal core teams, diagnostics partners, and external global CROs to ensure the global execution of the Companion Diagnostic assays in oncology

Reviewed and analyzed medical and scientific literature using PRISMA Medline, EMBASE and Pub-med to prepare manuscripts as per GPP guidelines, and patent applications, managed references and bibliography using EndNote.

Authored and submitted to NIH FOUR SBIR I, THREE SBIR II, and THREE RFA (U54)

Created ONE commercialization plan for a potential antipsychotic.

Prepared FIVE patent applications and identified FOUR potential intellectual properties

Prepared standard operating procedures (SOPs) for kinases and QA/QC guidelines

Senior Research Scientist Jan 1990 – April 2002

American Health Foundation, Valhalla, New York

Conducted pioneering research on molecular basis to reverse colon cancer; developed diagnostic and biomarkers, evaluated latest biotechnological methods, processes, products, and market place conditions to assess commercial potential of biomedical research; successfully competed for research funds from NIH and private industry, wrote grants, prepared budgets, managed research projects, trained research staff, and published and presented original research papers in peer reviewed journals and international conferences.

Created an in-vivo model of colon cancer to identically mimic the formation of human colon polyps and colon tumors in rats.

Established standardized operating procedures for specimen collection, processing, and analysis using biochemical, histological, enzymatic assays, and molecular methods.

Biotechnological procedures included radioimmunoassay (RIA), ELISA, tyrosine kinase assays, HPLC, immune-histochemical analysis of cells and tissues (frozen and paraffin embedded), gene expression analysis, and spectrophotometric assays.

Molecular methods included gene cloning, DNA and mRNA analysis, PCR, RT-PCR, SDS-PAGE, northern blotting, southern blotting, western blotting, RIA, EIA, HPLC, DNA sequencing, protein sequencing, and receptor-ligand interactions analysis.

Conducted SSCP and genomic sequence analysis to detect single point mutations in ras genes and p53 genes on more than 5000 tissue samples using Sanger Sequencing (Applied Biosystems) as part of NIH funded original research involving cancer genetics. This work produced 15 original research articles published in peer-reviewed journals.

Wrote proposals and made presentations before esteemed scientists and administrators to realize $9.5MM through persuasive writing and articulate public speaking in four RO1 grants, one program project PO1 and three research grants from private industry.

Set up and proactively managed molecular biology lab.; trained and supervised professional and technical staff, managed budget, purchased equipment, administered operations and security of highly contagious containment research facility.

Completed an internal research project to analyze the ten-year history of deal-making trends including return on capital within the biotech/biopharmaceutical industry, conducted due diligence and business intelligence.

Completed five (5) projects for Merck and one (1) project for Boehringer Ingelheim providing due diligence and business intelligence for product evaluation and product launch in North America.

Analyzed gene mutations in K-ras and p53 genes and developed molecular diagnostic marker for colon cancer formation.

Measured the anti-cancer effect of nutritional factors and non-steroidal anti-inflammatory drugs (NSAIDs) such as COX-2 inhibitors on signal transduction, gene expression, and tumor regression.

Designed, developed and managed cancer research database, prepared data summaries, quarterly and annual research progress reports, monthly research seminars, prepared conference presentations, and manuscripts for publications.

PUBLICATIONS & PRESENTATIONS

Published 25 original research papers in peer-reviewed international journals as lead author, and delivered more than 25 presentations at international conferences, seminars, and symposia in the US, UK, Canada, Japan, India, Germany, and France.

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