Responsible for the oversight of a number of projects within Research Units and providing BioMedicine Design - Pharmacokinetics, Dynamics & Metabolism (BMD-PDM) - focused leadership and strategic direction to assigned projects from early discovery through loss of exclusivity.
- Identifies key BMD-PDM related project attrition risks and in collaboration with internal BMD stakeholders creates and integrates this risk-mitigation strategy into the overarching project strategy.
- Ensures execution of the BMD-PDM strategy in partnership with BMD scientists.For example, works with bioanalytical scientists to ensure the appropriate assays, interfaces with biomarker scientists, PK/PD modelers and other biotherapeutic BMD-PDM partners to develop quantitative translational pharmacology plans, ensure appropriate PK predictions and dose projection approaches, and develop immunogenicity risk assessment and mitigation strategies.
- As the BMD-PDM lead to project team(s), the scientist is expected to integrate nonclinical pharmacokinetic, pharmacodynamic and metabolism knowledge, influence the preclinical project plans, and drive optimization of biotherapeutic molecules.
- The candidate will also advance the science and strategies for prosecuting biotherapeutic projects as well as influence external scientific and regulatory practices through publication and other interactions.
- Liaises with: Core discipline groups within BMD, and interacts with the Project Leader and scientists in Biology departments, Drug Safety, Pharmaceutical Sciences, and Clinical departments at all stages of discovery and development.
- PhD with 8+ years of work experience (of which at least 4 years in pharmaceutical industry) in Pharmacokinetics, PK/PD, or relevant field
- Solid understanding of the basic principles of pharmacokinetics (non-compartmental, compartmental)
- Working knowledge in the pharmacokinetics and disposition of biotherapeutic modalities.
- Solid understanding of immunological and other biotherapeutic bioanalytical assays.
- Good understanding of PK/PD modeling and the application to advance projects from idea to clinical development.
- Experience integrating data from multiple sources into a rational understanding of absorption, distribution, clearance, PK/PD, and immunogenicity
- Demonstrated collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.
- Excellent oral, written, and presentation skills demonstrated through internal and external presentations.
- Excellent interpersonal relationship skills
- Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of regulatory guidelines is preferred