Senior Manager PKPD
Location: Princeton, NJ
Salary: $120,000-$140,000 + relocation
A pharmaceutical manufacturing company is looking to hire a Senior Manager of PKPD!
Responsibilities:
- Hands-on design, conduct, interpretation, and reporting of pharmacokinetic study and the result
- Provide pharmacokinetic expertise and support across therapeutic areas including CNS, oncology, DM and CVS
- Assist medical monitor in overall clinical development strategy, design of specific clinical pharmacology/pharmcokinetic studies including the design of modelling and simulation-based assessments for Luye's clinical projects
- Collaborate with medical monitor and clinical operation in evaluation of Contract Research Organization (CRO) capabilities. Actively participate in review and monitoring of outsourced PK/PD-related activities
- Work in close collaboration with Bio statistics and Programming group
- Develop/author/review (including QC) relevant components for various internal documents and presentations
- Support projects in all development stages using mechanism-based modelling & simulation methodologies
- Collaborate with preclinical PKPD department in addressing critical PK and PK/PD related questions, enable time-appropriate decision-making for clinical development programs
Qualifications:
- Ph.D. in Pharmacokinetics or a related field
- 5 years pharma industry experience
- Proficiency in Phoenix/WinNonLin preferred; NONMEM required
- Experience in inter disciplinary projects
