Responsible for the pharmacokinetic, dynamics and metabolism (PDM) oversight of a number of projects within Research Units and providing drug metabolism, analytical, pharmacokinetic, immunogenicity and pharmacodynamics focused leadership and strategic direction to assigned projects from early discovery through loss of exclusivity.
Identifies key PDM / DMPK 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 Bio-Medicines Design (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.
BS or MS or Phd with 8+ years of work experience (of which at least 4 years in pharmaceutical industry) in DMPK, 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
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EEO & Employment Eligibility
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Other Job Details:
Location: Cambridge, MA
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Employer will assist with relocation costs.
Internal Number: 4744427
About Pfizer Inc.
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, visit www.pfizer.com. For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines