We are seeking a (Senior) Director, Pharmacometrics, Quantitative Pharmacology, and Modeling & Simulation to establish quantitative pharmacology and PK/PD modeling & simulation as a core capability at Unity. The underlying discipline is intended to be a key part of each program’s asset strategy and also to be an integral consideration for platform projects and external collaborations.
This individual will be responsible for the development and use of a variety of approaches for the mechanistic modeling of biological systems, including disease state models, disease progression models, drug-disease models, models of intracellular signaling pathways, cell networks dynamics, and mechanistic PK/PD models. Among the most valuable uses of these methods will be to support the precision medicine goals of Unity to deliver medicines that treat diseases associated with aging to those patients most likely to benefit.
Key technical responsibilities are to develop QSP models in the context of specific molecule or therapeutic area needs to support clinical trials such as dosing, patient selection, biomarker and diagnostic investigation, combination therapy identification and optimization. Other key responsibilities include leading QSP related interactions with cross-functional teams, presenting at team meetings, department meetings, senior management review committees, regulatory interactions, scientific conferences, and writing QSP related sessions such as analysis plans, reports, and regulatory documents. These will be accomplished by working in close partnership with other scientists in Clinical Pharmacology, Preclinical and Translational PK, DMPK, Clinical Science, Biomarker, Diagnostics, Safety Assessment, Biostatistics, Regulatory, and other functions on project teams. Qualified individual could be responsible for overseeing the strategy and implementation of QSP and other M&S activities by other scientists across projects.
- Development of Quantitative Pharmacology models for application to specific molecules and programs to support pre-clinical experimental design and learning and translation to human clinical research
- Apply QP models for us in clinical trials for using in dose-level and dose-regimen determination, patient selection, biomarker and diagnostic evaluation and qualification, and most appropriate combination therapy assessment.
- Raise awareness of QP techniques and applications to all program teams and functions
- Represent Unity at all regulatory interactions related to clinical pharmacology topics
- Working closely with Translational Medicine and Biomarker groups to establish modeling support for predictive, target engagement, and PK/PD biomarkers as wells as the support necessary to develop the experimental plan for a potential companion diagnostic
- Apply modeling to decision analyses that can be applied to multiple applications including clinical trial simulation and trial design, benefit-risk analyses, indication selection, and collaborative opportunities
- Prepare documents for the submission of clinical protocols and regulatory submissions
- Bring maximum value of QP capabilities by working closely with scientists (both internal within Unity and external with partners) in Medical, Translational Medicine, DMPK, Biomarker Research, Bioinformatics, Diagnostics, Pharmacovigilance, Biostatistics, Regulatory, and all other functions on project teams.
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, or a related field
- Minimum of 8 years experience in the pharmaceutical industry with previous history working with PK/PD modeling, clinical trial design and application, regulatory interactions, and decision analysis.
- Experience working with translational scientists in biomarker discovery and development
- Strong understanding of regulatory approaches for use of pharmacometrics in drug development paths across the world including expecting requirements for analytic and clinical qualification and validation of assays
- Established relationships with modeling & simulation groups around the world
- Expertise in the integration of preclinical research and clinical drug development
- Experience in setting priorities, directing projects and implementing complex strategies
- Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines
- Able to communicate in both written and verbal format complex and detailed information in a manner that enhances understanding and ensures that the recipient will be able to apply the information presented