We are seeking a Senior Scientist 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.
- Works with the project team and key personnel in BMD-PDM to implement risk mitigation strategies and the regulatory documentation required in PDM to progress programs out to a key go/no go decision point in discovery and development.
- Ensures execution of the BMD-PDM strategy in partnership with BMD scientists. For example, works with bioanalytical scientists to ensure the development of appropriate assays;, interfaces with biomarker scientists, PK/PD modelers and other biotherapeutic BMD-PDM partners to develop quantitative translational pharmacology plans; ensures appropriate PK predictions and dose projection approaches; and develops immunogenicity risk assessment and mitigation strategies.
- As the BMD-PDM lead to project teams, the scientist is expected to integrate nonclinical pharmacokinetic, pharmacodynamic and metabolism knowledge, influence the preclinical project plans, and drive optimization of biotherapeutic molecules in collaboration with BMD protein engineers.
- 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 >1 year of work experience in the pharmaceutical industry or at least 1 year post-doctoral experience in Pharmacokinetics, PK/PD, or relevant field (or MS/BS with 5 or more years)
- Understanding of the basic principles of pharmacokinetics (non-compartmental, compartmental)
- Working knowledge in the pharmacokinetics and disposition of biotherapeutic modalities.
- Understanding of immunological and other biotherapeutic bioanalytical assays.
- General understanding of PK/PD modeling and the application to advance projects from idea to clinical development.
- General understanding of integrating data from multiple sources into a rational understanding of absorption, distribution, clearance, PK/PD, and immunogenicity.
- 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.
- Some knowledge in the preparation of regulatory applications (IND, NDA, BLA) and regulatory guidelines is preferred.
Ability to perform and communicate mathematical calculations
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Due to the global nature of some projects supported, occasional flexibility in timing of work hours.
Eligible for Employee Referral: YES
Eligible for Relocation: YES