Bryant Tran
- Role
- Medical Affairs Scientific Director at GSK
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Bryant Tran
Possesses a wide array of experiences in the development of drug products in the academic…
Experience
Medical Affairs Scientific Director
Jul 2011 — Present
Served as primary US medical affairs lead of pipeline products - uncomplicated urinary tract infection, gonorrhea, anemia of chronic kidney disease, rheumatoid arthritis, pruritus associated with primary biliary cholangitis, and hepatitis B (e.g, developed a medical plan with a budget and headcount needs for several assets; provided guidance to the integrated evidence team, global medical affairs team, and commercial team; US congress planning lead; provided medical insights on market research questions; analyzed business development opportunities)-Served as a scientist for medical affairs activities to support a rare disease indication, Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss syndrome)(e.g. congress planning, promotional review, advisory board execution, expert engagement)-Served as lead scientist for medical affairs activities to support gene therapy assets (e.g, evaluated external experts, provided medical insight to the commercial team, developed medical affairs plans)-Served as lead scientist for medical affairs activities in support of a pulmonary arterial hypertension product (e.g, authored a clinical overview to fulfill the EMA article 30 referral requirements, contributed to the article 45/46 submission of pediatric data, created a product profile for a country specific submission, provided medical review over marketing promotional materials, generated feedback from external experts in the setting of an advisory board)-Served as clinical investigation lead to support the transfer of manufacturing sites for a modified release formulation of a cardiovascular product (e.g. bioequivalence study)-Composed 59 safety narratives for a Neurology asset that required a swift turnaround for a regulatory submission-Prepared NDA annual reports and development safety update reports for several assets -Reviewed prescribing information for concomitant medications to determine associations with adverse events of interest.
Education
University of Southern California
Pharm.D., MS Regulatory Science
2005 — 2009
Duke University - The Fuqua School of Business
Master of Business Administration (MBA)
2014 — 2015
UC Irvine
BS, Biology
2001 — 2005
Skills
- Protocol
- Fda
- Clinical Development
- Medical Affairs
- Clinical Research
- Regulatory Affairs
- Pharmaceutical Industry
- Drug Development
- Gcp
- Clinical Trials
- Pharmacovigilance
- Clinical Pharmacology
- Pharmacology
- Regulatory Submissions
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.