AssociateDirectorClinicalPharmacology

As an **Associate Director** **Clinical Pharmacology** this individual is expected to proactively-identify and provide significant Pharmacometrics (PMx) contributions potentially of a complex nature for research and development programs. They are expected to address strategically important program needs that represent scientific advancements of one or more programs and/or aptly address significant regulatory hurdles. Is regarded as an expert in the field; as such is able to contribute to the overall strategic program development and is able to communicate complex PMx strategies and results in an influential manner to the development team. They are also expected to independently design, conduct and oversee the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses. **A day in the life an Associate Director may look like:** * As a PMx Program Representative on program teams, effectively communicate complex PMx results in colloquial terms and understandable to the development teams with the ability to be influential with the development team. * Independently plans and conducts or otherwise oversees the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses and has final responsibility for ensuring the accuracy of analyses. * Independently authors PMx contributions to regulatory documentation, including those for pre-IND, EOP2, and pre-BLA meetings. Performs additional analyses as required to support regulatory interactions. * Is able to Independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review. * With limited guidance from senior departmental staff, works directly with development or Research teams on PMx elements of program strategy and the PMx aspects of study * design and resu