Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The Senior Scientist, Pharmacokinetics will provide the data analysis and report writing in support of non-clinical TK/PK studies and clinical phase 1 through phase 3 studies, with the essential capability of PK/PD modeling and simulation.
• Draft, review and finalize non-clinical TK/PK reports within designated timelines.
• Fulfill the role of PK representative in a clinical study, communicate with clinical team to resolve issues pertinent to PK.
Perform PK/PD analysis and results interpretation, finalize reports within designated timelines. Collaborate with peers in bio-analytical, drug metabolism, toxicology, pharmaceutical sciences, biology, QA, biostatistics and clinical regulatory areas on PK requests.
• Conduct PK and PD modeling/simulation for DDI and dose selection purpose.
• Prepare and review clinical protocols and study reports and other non-clinical and clinical documents for IND and NDA submission. Prepares and reviews scientific publications and abstracts.
• Other duties may be necessary.
• PhD degree in pharmacokinetics, pharmaceutical sciences or related fields with zero to one year of industrial hands-on experience in PK field.
• Strong background in clinical and non-clinical pharmacokinetics and drug metabolism, with data analysis experience in clinical phase 1 and 2 studies.
• Experienced in using WinNonlin, Nonmem and R programs. Possess capability of population PK/PD modeling and simulation.
• Familiarization with Simcyp software is a plus.
• Good written and verbal communication skills in results interpretation and scientific report rewriting.
• May necessitate working outside “regular” work hours.
Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases. Ardea Biosciences, Inc. a San Diego based Biotechnology Company, is focused on the development of small molecule therapeutics for the treatment of serious diseases.