Clinical Pharmacology Scientist
The Clinical Pharmacology Scientist will have the opportunity to:
- Define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of studies.
- Plan and execute clinical pharmacokinetic and pharmacodynamic analyses to support portfolio projects.
- Apply quantitative approaches to develop and implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions.
- Participate on and provide input to project teams
- Contribute to regulatory documents (INDs, clinical trial documents including protocols and study reports, IBs, NDAs)
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to address significant unmet medical needs and transform existing treatment paradigms for patients. The Company currently has three different assets in various stages of clinical development. All three were discovered through the use of the Company’s peptide technology platform. PTG-300 is an injectable hepcidin mimetic in development for the potential treatment of iron overload and related blood disorders, including hereditary hemochromatosis and rare diseases such as beta-thalassemia and polycythemia vera. PTG-200 is an orally delivered, gut-restricted interleukin-23 receptor specific antagonist peptide in Phase 2 clinical development for the potential treatment of inflammatory bowel disease, with Crohn\'s disease as the initial indication. The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the clinical development of PTG-200. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in clinical development for the potential treatment of inflammatory bowel disease, with a Phase 2 ulcerative colitis study expected to commence in the second quarter of 2020.
Protagonist is headquartered in Newark, California. For further information, please visit http://www.protagonist-inc.com.
- Medical degree, PharmD or Ph.D. (or equivalent) with at least 3-5 years experience in pharmaceutical drug development.\r\n
- Good working knowledge of the drug discovery and development process.
- Background in pharmaceutical sciences, pharmacometrics, mathematics, (bio)statistics, biomedical engineering, or a related field.\r\n
- Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations) through regulatory filings (IND, NDA/BLA, MAA)\r\n
- Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development\r\n
- Proficiency in R, NONMEM, Phoenix WinNonlin, NLME, Matlab, SAS, or other similar applications\r\n
- Experience in performing population PK and PK/PD analyses using pharmacometric software\r\n
- Experience in experimental study design, problem solving, critical data analysis and interpretation\r\n
- Scientific understanding of biopharmaceutics, ADME, and clinical pharmacology\r\n
- Good written and verbal communication, interdisciplinary collaboration and problem solving skills and ability to work in a face paced environment\r\n
How to apply
Outstanding candidates with preclinical and clinical development experience and a passion for innovative drug discovery & development are encouraged to review our posted opportunities. Experience in the field of peptide therapeutics is a plus. If you wish to join an exciting clinical-stage company that has world-class drug discovery capabilities aimed at significant unmet medical needs, please contact us @ email@example.com.