Executive Director, Quantitative Pharmacology and Pharmacometrics

* Leading a team of up to 7 QP2 scientists including people management, scientific and operational oversight, under the direction of the Therapeutic Area Head of Immunology* Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors* Maintaining a comprehensive understanding of global regulatory expectations for all relevant modalities, shaping the clinical pharmacology regulatory strategy for selected immunology assets, and ensuring high quality regulatory documents (INDs, CSRs, CTDs)* Implements quantitative clinical pharmacology, pharmacometrics and translational modeling efforts to streamline drug discovery and development strategies and integrating knowledge to inform key decisions* Engaging as an expert representative for QP2in cross-functional and governance discussions, including business development and licensing evaluations* Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes* In partnership with the Therapeutic Area Head of Immunology, identify resource needs and contribute to resource allocation internally* Fostering a culture of collaborative and high-performing teamingApplies immunology knowledge and strategic thinking to identify, prioritize and develop enabling modeling platforms (disease, mechanistic, comparator models) at scale to create a differentiated immunology portfolio in an end-to-end manner in partnership with key internal/external collaborators* Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, computational biology, or a related field* Immunology therapeutic area and translational science knowledge* Demonstrated experience in regulatory strategies in Immunology including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)* Extensive experience in developing quantitative strategies for impacting pipeline decisions across different phases, and including complex modalities* Strong understanding of functional deliverables in drug R&D, with an ability to connect QP2 contributions to broader activities and needs* Demonstrated ability to lead interdisciplinary teams or taskforces, and to oversee and drive results through the work of others* Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity* Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning* Expert skills in performing mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., Mathlab, NONMEM, R, Monolix, Phoenix, etc.)* Scientific understanding of biopharmaceutical and ADME properties across modalities* Record of applying mechanistic models to inform decisions* Recognized leader in the field of quantitative pharmacology with a track record of sustained external visibility through publications, presentations and/or involvement in professional organizations**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr MSD Malaysia