Associate Director PKPD
Proclinical is currently recruiting for an Associate Director for a pharmaceutical company located in West Windsor Township, New Jersey. Successful candidate will provide pharmacokinetic expertise and support across therapeutic areas including CNS, oncology, DM and CVS.
- Hands-on design, conduct, interpretation, and reporting of pharmacokinetic study and the result.
- 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 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 Biostatistics 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.
Skills and Requirements:
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology or related fields with a specific focus on pharmacokinetics.
- 5+ years' pharmaceutical industry experience in conduct of pharmacokinetic support.
- Extensive experience with quantitative approach in describing PK/PD systems using preclinical and clinical data and demonstrated ability to apply quantitative tools to enable rational and efficient drug development are required.
- Proficiency in WinNonlin/Phoenix is preferred; experience in NONMEM and/or other modeling and simulation software is required.
- Broad experience in mechanism-based PK/PD research of biologic therapeutics is strongly preferred.
- Experience in supporting interdisciplinary projects.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.