Associate Director, Clinical Pharmacology

In collaboration with the VP, Clinical Development, lead clinical pharmacology strategy across development portfolio from pre-IND to post-approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.

Responsibility:

•  Integrates

clinical pharmacology knowledge with a broad understanding of, and

collaboration with, related disciplines such as clinical, statistics,

regulatory, nonclinical ADME, toxicology to support and impact development

decisions

 • Ensures

appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD

modeling and simulation) are conducted for each study/program.

• Collaborates with internal and external

stakeholders to design, analyze, interpret, and report preclinical PK and

translational PK/PD studies to support candidate selection and IND filing,

including human PK prediction to support starting dose and dose escalation

schemes for first-in-human studies

• Serves as the clinical Pharmacology expert across

study and program teams • Contributes to program strategy, study design,

protocol preparation, study execution, data review/analysis, study reports and

regulatory document preparation

•Provides oversight to bioanalytical vendors, including method development and

validation as well as sample analysis

Requirements:

• PhD, PharmD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or

related disciplines and a minimum 10 years pharmaceutical or biotechnology

experience in Clinical Pharmacology

• Direct clinical management of Phase I healthy volunteer studies is a plus