This top 10 global pharma company is currently seeking a Principal Scientist of Clinical Pharmacology and Pharmacometrics to join their high-performing clin pharm team. This organization focuses on a wide range of therapeutic areas with several compounds in each phase of the drug development cycle including discovery through commercialization. This company leading the industry in multiple therapeutic areas including oncology, immunology, cardiovascular, infectious disease, and vaccines.
This organization is currently looking for a highly motivated Principal Scientist to contribute to compound development across phases and will give the opportunity to work closely with therapeutic heads and senior members of the organization to optimize dose selection and integrate PKPD knowledge into clinical study designs. Reporting directly into a Scientific Director, this professional will have the unique opportunity to work on phase II and phase III clinical studies and directly impact the advancing pipeline.
Contribute and collaborate with senior members and project officials on modeling and simulation activities while performing M&S analysis on translational data, preclinical and clinical data, and first-inhuman dosage on drug development programs.
Paritcipate as a key clinical pharmacology representative in regulatory meetings related to pre-IND filings, NDA filings, BLAs, etc
Thrive in a matrixed environment to lead clinical pharmacology aspects of drug development programs to drive deliverables in accordance to overall company aspirations.
Lead the design of Phase I through to Phase III clinical pharmacology studies and interpret PK and PKPD results accordingly
PhD in Pharmaceutical Sciences, Pharmacology, Pharmacometrics, or related field
2 years of industry experience in either biotechnology, pharmaceutical, or CRO setting OR 4 years of postdoctoral experience
Experienced in modeling tools such as NONMEM, WinNonlin, R, GastroPlus, SAS or similar for the purpose of conducting simulations for PK and PKPD
Deep understanding of overall PK or PKPD and how it relates to overall clinical pharmacology strategies
Experience in immunology is preferred but not required