Senior Pharmacokineticist

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jul 15, 2021
Ref
R-132270
Discipline
Clinical
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Opportunity:

We have an exciting opportunity available for a Senior Pharmacokineticist to join the Pharmacokinetics/Quantitative Systems Pharmacology (PK/QSP) group. The PK/QSP group supports projects throughout the Drug Discovery, R& D continuum, for all therapeutic areas and a diverse repertoire of drug modalities, including biologics as well as novel approaches such as cell-and gene-therapy.

This position will play a key cross-functional collaborator role within Pharmacology & Toxicology as well as with colleagues from Research, Bioanalysis, CMC, Translational and Data Sciences, Biostatistics, Clinical Pharmacology, Pharmacometrics, and Clinical Development. As a Senior Pharmacokineticist, your research will focus on applying quantitative modeling and simulation methodologies to describe and interpret PK and PKPD data, characterize dose-concentration-effect relationships, and inform decision making.

Reporting into the Director, Pharmacokinetics & Quantitative Systems Pharmacology, your main responsibilities include:

  • Serve as the lead PKPD project scientist for a variety of programs and drug modalities; biologics and novel platforms such as cell- and gene-therapy, gene-editing, and non-viral gene delivery.
  • Provide scientific expertise and guidance in biologics research and development related activities and is willing to evolve knowledge into novel areas of interest, such as gene therapy.
  • Serve as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies.
  • Perform advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making.
  • Lead study design discussions, study protocols development, including sample size calculations, data analysis plan, and report population PK and PK/PD analysis results to management and review committees.  
  • Actively maintain relationships and collaborate with colleagues within the Pharmacology/Toxicology organization and CSL Behring at large.
  • Establish and maintain external collaborations with academic groups active in a variety of ADME/PKPD areas of research worldwide.
  • Setup contracts and interface with external vendors per business requirements.

Required Qualifications

  • A PhD in Pharmaceutical Sciences or related subject area with six years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation or a Master’s degree in Pharmaceutical Sciences or related subject area with 8 years of relevant experience.
  • Thorough knowledge of pharmacokinetics, PK/PD modeling principles, as well as basic statistics.
  • Hands-on experiences with population approach in describing PK/PD data, using industry standard software packages, such as Phoneix WinNonLin, NONMEM, R, etc.…
  • Demonstrated experience in planning, overseeing, evaluating, and reporting PK/PD studies.
  • Experience reviewing and applying statistical analyses to inform preclinical study design; sample size…. etc. is highly desirable
  • Demonstrated experience supporting biologics research and development projects in collaboration with internal or external experts.
  • Excellent communication and interpersonal skills is required


 

If you would like to work for a purpose-driven, values-based organization, apply now!

CSL is an Equal Opportunity Employer.

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