Director, Clinical Pharmacology

5+ years of experience in the application of CP within the context of drug development in the healthcare industry.

Hands-on experience in pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM or Monolix, and R) for individual (e.g., noncompartmental analysis, NCA) and population PK/PD (PopPK/PD) analysis, modeling and simulations (M&S), and exposure-response (E-R).

Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases is preferred.

Knowledge of current practices, regulatory requirements in clinical development, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development.

Reporting to Vice President, Translational Science, this position is responsible for providing strategic and scientific expertise, representing Clinical Pharmacology (CP) in the highly dynamic cross-functional clinical development team, as well as collaborating with both internal and external stakeholders to deliver the tactical execution of our CP strategy.

This role will work as an independent contributor to provide CP subject matter support to new and on-going clinical programs.

Develop and maintain comprehensive CP strategic development plans for all clinical development programs/studies.

Provide expert-level CP and expert to the clinical study team/development team.

Collaborate with Quantitative Pharmacology (QP) vendors or colleagues to develop and deliver quantitative strategies to support assigned development plans.

Formulate and finalize CP related report templates, as well as data handling and analysis standard operating procedures (SOP).