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Position:
Principal Scientist (DMPK) | Apply Here: https://smrtr.io/7dcj9
Employer:
Exelixis
Description:
- Develop and drive the DMPK and pharmacokinetics-pharmacodynamics (PKPD) strategy for development projects to support project decisions and milestones
- Serve as DMPK and BA representative on project teams supporting the development of novel drug candidates (small molecules, possibly biologics and antibody drug conjugates) for the treatment of diseases in Oncology, and Immuno-Oncology
- Collaborate with project team members (Project Management, Discovery Biology, Chemistry, Chemistry Manufacturing and Control, Regulatory), and groups within Translational Sciences (Bioanalytical, Toxicology, Translational Pharmacology, and Clinical Pharmacometrics) to generate relevant data to enable knowledge & data integration to inform and guide target validation, biomarker selection, and candidate advancement
- Analyze and integrate in silico, physicochemical, ADME, and DMPK data to support molecule design & selection with particular attention to the impact of drug metabolism and drug-drug interactions
- In collaboration with key partners, may develop PK/PD models that will generate data and knowledge to support robust translational and biomarker strategies
- Coordinate and request PK, PKPD, and bio-analytical studies internally and externally (with CROs) in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times
- Assist in the preparation of DMPK-BA sections of regulatory documents (IB, IND, NDA BLA); assist in providing responses to regulatory questions & ensure generation of appropriate reports
Qualifications/Experience:
- BA/BS in Pharmaceutical Sciences or related field with 10 years of exp, or
- MA/MS in Pharmaceutical Sciences, or related field with 8 years of exp, or
- Doctorate (PhD) with a min of 5 years of exp Pharmaceutical Sciences or related field
Location:
Alameda
Contact:
Mbland@Exelixis.com
Post Date:
12/13/2021 2:29:17 PM
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