PROFESSIONAL SUMMARY
A highly motivated healthcare professional with more than 10 years of combined biopharmaceutical industry and clinical research experiences seeking a challenging opportunity within the biopharmaceutical industry to accelerate access to medicines for the benefit of patients. Equipped with well-defined leadership, problem-solving, interpersonal, and organizational skills; along with effectiveness in building strong relationships and working collaboratively with management, medical professionals, cross-functional teams, and diverse individuals.
AREAS OF EXPERTISE
Protocol Development
Good Clinical Practice
Regulatory Agencies
Consultation Service Delivery
Patient Training and Education
Product Knowledge
Data Review and Analysis
Clinical Trial Materials Development
Rare Disease and Oncology Exposure
Clinical Supply Strategy and Management
Management
Clinical Report Documentation
Personnel Training and Supervision
Interactive Response Technology
PROFESSIONAL EXPERIENCE
Pfizer, Inc., Groton, CT
Clinical Supply Strategy and Management Fellow Chief Fellow Jul 2018–Present
Function as supply chain lead responsible for collaborating with Business, Research, Medical, Regulatory, and Product Development teams
oLead clinical supply team in asset management and delivery to meet manufacturing, packaging, distribution, and clinical study timelines and expectations
Facilitate global clinical trials utilizing small molecule, biologics, and gene therapy investigational products (IP) in first-in-human studies through commercialization
Design appropriate clinical supply strategy and managing clinical supply risk and cost in alignment with the clinical protocol, BU/RU budget, and regulatory environment
oMitigate potential patient impact associated with limited clinical supply availability for a global study
valued at $600,000
Demonstrate expertise across global clinical supplies on clinical site/pharmacy operations, aseptic preparation guidelines for injectables, and clinical disease state and patient journey reviews
Maintain proactive interaction with clinical project teams to assist in authoring and developing clinical trial materials focused on healthcare providers and patients
Support cross-functional collaboration in the development of clinical strategies
oContribute to authoring of study protocols, IP manuals and dosage and administration instructions, site training tools, and patient adherence aids
oParticipate in investigator meetings, conduct clinical site visits, and guarantee safe use of IP, while offering consultation to clinical project teams on medication-related issues such as concomitant medications and patient adherence
Food and Drug Administration, Silver Spring, MD
Center for Drug Evaluation and Research Extern Feb 2018–Mar 2018
Executed literature reviews and assessment of real-world data using medication databases to support labeling quality initiatives resulting in clinically relevant, evidence-based labeling, and medical communications delivering informed use of drugs and biologics to vulnerable populations
Texas Center for Drug Development, Inc., Houston, TX
Senior Clinical Research Coordinator Research Team Manager Apr 2012–Aug 2013
Implemented Food and Drug Administration (FDA) -approved trials in compliance with FDA and GCP guidelines
Authored and executed standard operating procedures (SOPs) and recruitment strategies, while ensuring adherence to GCP guidelines in gathering and maintaining patient and laboratory data for clinical research projects
Responsible for preparing regulatory submissions and Institutional Review Board (IRB) renewals; performing site monitoring visits/investigator meetings with sponsors; managing expenditures and compliance to examine budgets and resolve billing issues in coordination with finance and management staff
Executed protocols from startup through close out, which involved identification of eligibility and collection of consent from study participants
Observed strict conformance with research protocols in documenting audit case report forms for completion and accuracy with source documents
Acted as main point of contact with research participants and interfaced with principal investigator to guarantee patient safety and adherence to proper study conduct
Endocrine Associates, Houston, TX
Clinical Research Coordinator Aug 2009–Mar 2012
Drove initiatives in facilitating clinical trials in compliance with FDA and GCP guidelines; restructuring the Research Department; and conceptualizing, authoring, and delivering SOPs
Assessed medical records and conducted telephone/in-person interviews to obtain data, as well as aided with screening, recruitment, and gathering of consent of study participants
Implemented basic measurements and tests on patients based on protocol, which involved taking vital signs and performing phlebotomy and electrocardiogram (EKG) upon completing appropriate training/certification
Managed the collection, creation, and shipping of study specimens according to protocols; purchasing and maintenance of equipment, supplies, and investigational products; and processing of study compensation payments and thank you letters to subjects upon completion of trial activities
Accountable for carrying out quantitative review of forms, tests, and other measurements for completeness and accuracy; extracted data from source documents for research studies; and administered standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry
TEACHING EXPERIENCE
Massachusetts College of Pharmacy and Health Sciences (MCPHS), Boston, MA
Adjunct Assistant Professor, Pharmacy Practice Jul 2018–Present
Provide education on multiple courses such as Therapeutics, Introduction to Biopharmaceutical Industry and Patient Behind the Pills–Substance Use Disorder
Serve as co-preceptor for PharmD students while on rotation
California Health Sciences University, Fresno, CA
Teaching Assistant and Tutor Aug 2015–May 2018
Offered administrative support to faculty members, aid student learning, and rendering tutoring services to individual students and groups
EDUCATION
Doctor of Pharmacy: May 2018 California Health Sciences University, Clovis, CA
Summa cum laude
Doctor of Medicine: Aug 2009 Avalon University School of Medicine, Willemstad, Curaçao
Magna cum laude
United States Medical Licensing Examinations (Step 1, 2CK, 2CS, and 3)
Educational Commission for Foreign Medical Graduates (ECFMG) Certified
PROFESSIONAL DEVELOPMENT
License
Pharmacist License: State of Texas (License Number: 66141)
Certification
Pharmacy Resident Teaching Certificate – MCPHS University: May 2019
Certified Immunizer – Accreditation Council for Pharmacy Education: 2016–Present
Health Insurance Portability and Accountability Act (HIPAA) Certification: Apr 2015–Present
Educational Commission for Foreign Medical Graduates (ECFMG) Certified: May 2013–Present
Cardiopulmonary Resuscitation (CPR) Certification: Valid Until Jun 2021
Basic Life Support (BLS) Provider Certification: Valid Until Jun 2021
PRESENTATIONS / PUBLICATIONS
Chan, K., Othee, H., and Yadav, J. (Manuscript in progress). Amyloid Transthyretin Cardiomyopathy: Approaches to innovative therapies and disease impact on quality of life.
Yadav, J. (2019, August). Disease Overview and Investigational Trial Topic presentation. Duchenne Muscular Dystrophy (DMD): An overview of the disease and innovative therapies. Pfizer, Inc. Groton, CT.
Yadav, J., Snowden, S., Havard, P., Edgar, C., and Trueblood, P. (2016). Assessing the effectiveness of beers criteria for medication review on fall risks in older community-dwelling adults. American Society of Health-System Pharmacists Midyear Clinical Meeting, Las Vegas, NV.
Sethi, R. and Yadav, J. (2015). Environmental toxicology: A scientific perspective on estrogen mediated signaling in air pollution induced cardiac pathogenesis. In Hussain, D. (Ed.), Toxicology: The past, present, and future of basic, clinical and forensic medicine (Chapter 1: Environmental Toxicology: A Scientific Perspective on Estrogen Mediated Signaling in Air Pollution-Induced Cardiac Pathogenesis). Nova, NY: Nova Science.
Yadav, J. (2012). Best clinical practices; A focus on clinical practice on a site level. Texas Center for Drug Development, LLC. Houston, TX.
Yadav, J. (2008). Congenital heart defects, cardiac anomalies, and Kawasaki disease: Targeting awareness to the pediatric population. South DeKalb Pediatrics, Atlanta, GA.
(References available upon request)