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Team Lead, Head of Clinical Pharmacokinetics - Pharmacodynamics Analysis (m/f)

Posted 13 Aug 2018

Darmstadt, Hesse - Germany

Req Id 174235

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 
 


Your Role: The Head of PK/PD Data Processing will lead a team of PK/PD analysts who perform or oversee clinical PK and PK/PD data preparation, evaluation, visualization, and interpretation, and provide input to concept sheets, protocols, reports or presentations, informing and supporting (trial) teams and projects across all therapeutic areas. You will define, establish and maintain efficient, high quality processes and ensure that all PK/PD, submission-relevant analyses are provided on time and according to regulatory quality expectations. You will drive team members development, coaching, and ensure critical expertise, processes, and systems are maintained and sustained. The individual will effectively cooperate internally with various groups (Global early Development leads, clinical pharmacology, Biostatistics, Data Management, and Clinical Development) and with external partners to outsource clinical PK/PD work and oversees and track (e.g. through KPIs) study timelines, quality of deliverables, and budget.

 

Who you are:

  • Ph.D. in pharmacokinetics/Pharmaceutics/Pharmacy or a related discipline and at least 5 years of relevant industry or government experience
  • Expert knowledge in clinical research and development areas with demonstrated expertise and strong quantitative skills in PKPD data management and analysis using statistical and pharmacokinetic evaluation programs: SAS programming, Phoenix WinNonlin and PKS database, R
  • Expert Knowledge of data standards (CDISC's SDTM and ADaM), IT/ program validation / ICH/GxP
  • Excellent organizational, communication, and leadership skills
  • Coaching, mentoring, and people management skills
  • Fluent spoken and written English. Additional local language is an asset


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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