Shawn Flanagan

Shawn Flanagan Email and Phone Number

Senior Vice President Clinical Pharmacology and Translational Development @ Elion Therapeutics
San Diego, CA, US
Shawn Flanagan's Location
San Diego, California, United States, United States
Shawn Flanagan's Contact Details

Shawn Flanagan work email

Shawn Flanagan personal email

n/a
About Shawn Flanagan

Highly accomplished and influential scientific leader with diverse knowledge of drug development and translational research. Dynamic and effective communicator across disciplines and between levels, internally and externally, demonstrating both technical mastery and broad holistic perspective. Creatively advanced a variety of compounds of several therapeutic areas including infectious disease, endocrine, neuroscience, and oncology from Discovery/Pre-IND, proof of concept, NDA approval, and post-marketing. Responsible for all aspects of Biopharmaceutic, Clinical Pharmacology, and Pharmacokinetic (DMPK/ADME) studies, reports, and original regulatory submissions for BYDUREON, CONTRAVE, SIVEXTRO, and REZZAYO.

Shawn Flanagan's Current Company Details
Elion Therapeutics

Elion Therapeutics

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Senior Vice President Clinical Pharmacology and Translational Development
San Diego, CA, US
Shawn Flanagan Work Experience Details
  • Elion Therapeutics
    Senior Vice President Clinical Pharmacology And Translational Development
    Elion Therapeutics
    San Diego, Ca, Us
  • Cidara Therapeutics
    Vice President Clinical Pharmacology & Early Development
    Cidara Therapeutics Jan 2017 - Present
    San Diego, Ca, Us
  • Esperion Therapeutics, Ann Arbor, Mi
    Executive Director Clinical Pharmacology
    Esperion Therapeutics, Ann Arbor, Mi Jun 2016 - Jan 2017
    Ann Arbor, Michigan, Us
  • Merck
    Sr. Prin. Scientist
    Merck Jan 2015 - Mar 2016
    • Design, oversee conduct, interpret, and report results of clinical pharmacokinetic studies, develop modeling analysis plans, prepare regulatory submissions, represent functional area on 4 Anti-infective project teams.• Scientific Supervisor on all aspects of the program, including but not limited to document preparation, program strategy, modeling approaches as well as to educate, develop and review performance for Program Leads.
  • Cubist
    Senior Director Clinical Pharmacology
    Cubist Jul 2014 - Dec 2014
    Seoul, Gangnam-Gu, Kr
    Cubist was acquired by Merck in 2015.• Led studies to provide key differentiation from existing product using toxicology, primary and secondary pharmacology and clinical pharmacology approaches.• Championed clinical pharmacology and PK results: publications, congresses, presentations to health authorities, advisory boards, and potential partners.
  • Trius Therapeutics
    Executive Director Clinical Pharmacology
    Trius Therapeutics Jul 2011 - Jun 2014
    Trius was acquired by Cubist in 2013, with transition to Cubist job titles in 2014.• Led studies to provide key differentiation from existing product using toxicology, primary and secondary pharmacology and clinical pharmacology approaches.• Championed clinical pharmacology and PK results: publications, congresses, presentations to health authorities, advisory boards, and potential partners.• Responsible for all aspects of Biopharmaceutic, Clinical Pharmacology, and Pharmacokinetic (DMPK/ADME) studies, reports, and original regulatory submissions for SIVEXTRO.
  • Orexigen Therapeutics, Inc.
    Senior Director, Clinical Pharmacology
    Orexigen Therapeutics, Inc. 2009 - Jun 2011
    La Jolla, Ca, Us
    • Participated in key Regulatory interactions including serving as Clinical Pharmacology expert for FDA Advisory Committee, for CONTRAVE, a complicated fixed dose combination product with 4 active metabolites.• Responsible for all aspects of Biopharmaceutic, Clinical Pharmacology, and Pharmacokinetic (DMPK/ADME) studies, reports, and original regulatory submissions for CONTRAVE.
  • Amylin Pharmaceuticals
    Director Pkdm
    Amylin Pharmaceuticals 2004 - 2009
    San Diego, Ca, Us
    • Provided functional area leadership for all clinical and nonclinical PK, TK, and ADME support for peptide and protein therapeutics from Discovery through Commercialization.• Developed strategy and led cross-functional/matrix team to fast track drug approval using in vitro/in vivo correlation (IVIVC). • Responsible for all aspects of Biopharmaceutic, Clinical Pharmacology, and Pharmacokinetic (DMPK/ADME) studies, reports, and original regulatory submissions for BYDUREON.
  • Ligand Pharmaceuticals
    Sr Research Scientist Clinical Pk
    Ligand Pharmaceuticals Jul 2002 - Oct 2004
    Jupiter, Florida, Us
    • Responsible for the design, budget, outsourcing, implementation, conduct and reporting of PK, metabolism, and bioanalytical studies for oncology and dermatological products, associate supervision, interaction with health authorities, and contribution to strategic development plans.• Participated in budget preparation and managed monthly expenses, accruals and reschedules.
  • Eli Lilly
    Sr Pharmacologist Drug Disposition
    Eli Lilly 1999 - 2002
    Indianapolis, Indiana, Us
    • Designed, conducted and reported studies to evaluate the PK, PK/PD and GLP TK of drug candidates in animals, the absorption, distribution, metabolism and excretion, reviewed and approved quantitative bioanalytical methods and results in animals and humans, and led associate scientists and technicians as part of Toxicology/ADME team. • Translated from Discovery Pharmacology to clinic using modeling and simulation (PK/PD).• Represented PK, ADME, and Pharmacology on critical evaluation of in-license opportunities.
  • Pharmetrix Corporation
    Associate Scientist
    Pharmetrix Corporation 1990 - 1995
    • Project technical leader for multiple products. • Conducted pharmacokinetic analyses for preclinical and clinical studies.• Prepared reports and summaries for Regulatory submissions.• Supervised associates in the area of pharmaceutical formulation and in vitro /in vivo drug permeation testing.• Participated in scientific advisory board meetings, patent drafting and reviews, and client presentations.• Conducted interdisciplinary research activities involving bioanalytical, formulation, physical and polymer chemistry, and pharmacology for transdermal and controlled release formulations.

Shawn Flanagan Skills

Adme Clinical Pharmacology Clinical Development Drug Discovery Drug Metabolism Drug Development Pharmacokinetics Ind Clinical Research Pharmacology Clinical Trials Cro Regulatory Submissions Pharmaceutical Industry Biopharmaceuticals Biotechnology Glp Biomarkers Gcp Pharmacodynamics Oncology Good Laboratory Practice

Shawn Flanagan Education Details

  • University Of California, San Francisco
    University Of California, San Francisco
    Pharmaceutics

Frequently Asked Questions about Shawn Flanagan

What company does Shawn Flanagan work for?

Shawn Flanagan works for Elion Therapeutics

What is Shawn Flanagan's role at the current company?

Shawn Flanagan's current role is Senior Vice President Clinical Pharmacology and Translational Development.

What is Shawn Flanagan's email address?

Shawn Flanagan's email address is sf****@****ink.net

What schools did Shawn Flanagan attend?

Shawn Flanagan attended University Of California, San Francisco.

What skills is Shawn Flanagan known for?

Shawn Flanagan has skills like Adme, Clinical Pharmacology, Clinical Development, Drug Discovery, Drug Metabolism, Drug Development, Pharmacokinetics, Ind, Clinical Research, Pharmacology, Clinical Trials, Cro.

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