Post Job Free
Sign in

Medical Science Liaison

Location:
Gales Ferry, CT
Salary:
160000
Posted:
April 01, 2020

Contact this candidate

Resume:

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)



Contact this candidate