Senior Principal Scientist, Pharmacokinetics, Dynamics & Metabolism

Pfizer   •  

La Jolla, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 84 days ago

This job is no longer available.

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

  • 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.

BASIC QUALIFICATIONS

  • 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

PREFERRED QUALIFICATIONS

  • Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of regulatory guidelines is preferred

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