Principal PK & QSP Expert (m/f/x)

For our Research department, we are looking for a
Principal PK & QSP Expert (m/f/x)
Fulltime / permanent/ non-tariff
R-226285
The Opportunity
As Principal PK & QSP Expert you will serve as the lead PKPD/ ADME/QSP project scientist for a variety of programs and drug modalities; biologics, small molecules and novel platforms such as cell- and gene-therapy, gene-editing, and non-viral gene delivery. You will provide scientific expertise and guidance in biologics research and development related activities and will be willing to evolve knowledge into novel areas of interest, such as gene therapy
The Role

• One of your main responsibilities will be to acts as PK Study Director/Study Monitor for internal and external PK studies,
• You will serve as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies
• Another focus will be for you to 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
• You will 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
• As expert in the field you will provide technical guidance and mentor junior team members to achieve the project objectives
• You will actively maintain relationships and collaborate with colleagues within or outside the Pharmacology/Toxicology organization and CSL Behring at large and establish and maintain external collaborations with academic groups active in a variety of ADME/PKPD/QSP areas of research worldwide
  

Your Skills And Experience

• A PhD in Pharmaceutical Sciences or related subject area with 6 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 pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation.
• Training in PK/PD, modelling and simulation, using industry standard software packages, such as Phoenix WinNonLin, NONMEM, R, etc
• Demonstrated experience as PK Study Director/Study Monitor
• Demonstrated experience supporting projects using PK and PKPD capability
• Education/experience with Physiological Modeling a plus
  

What We Offer

• Innovative work-environment at our R&D campus
• CSL-subsidized company bike leasing
• Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
• Access to Gym facility on campus
• 2 Wellness days per year (additional paid time off)
• Family services such as psychological support, legal advisory, family care services and more for you and your direct family
  

For more information, please check out our global benefits below.
If located in the 2nd location, candidate will agree to travel to Marburg to oversee their study (travel funded by CSL)
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!