Clinical Pharmacokinetic Expert - Wuppertal, Deutschland - AiCuris Anti-infective Cures AG

AiCuris Anti-infective Cures AG
AiCuris Anti-infective Cures AG
Geprüftes Unternehmen
Wuppertal, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter


Beschreibung
Your role will be to provide clinical


Responsibilities:


  • Responsible for designing and planning PKfocused clinical investigations.
  • Responsible for PK monitoring, PK input, online followup of patients' PK data, participation in the preparation of statistical analysis plans and tables, figures and listings of clinical trials.
  • Responsible for the planning, analyzing, reviewing and reporting of PK/PD and popPK.
  • Writing of PK chapters in trial protocols and reports as well as critical review of these documents including quality check.
  • Writing/reviewing the clinical PK part of the investigator brochure and other regulatory documents and answering questions to the authorities.
  • Preferably able to support biostats for analysis of clinical trial data.
Skills and qualification

  • Successful graduation as pharmacist, physicist, mathematician or pharmacologist
  • More than 5 years of proven experience in planning and analyzing clinical PK trials, specifically Phase 1 and 2 trials as well as performing PK/PD and popPK analyses in the pharmaceutical industry or academia
  • Optimally also experience in designing and planning preclinical PK experiments, but not a prerequisite
  • Preferably handson biostatistical knowledge and working experience
  • Ability and experience in working as a team; inhouse, with CROs, experts and opinion leaders
  • Openness and respect for diversity
  • Leadership, organization, interpersonal communication, and presentation skills
  • Resultsoriented, capable of setting priorities and managing high workload at times
  • Small biotech mentality and flexibility to accept and perform the tasks of their directly reporting workers and colleagues across projects if necessary
  • Fluent in business English; writing and speaking in German would be beneficial
What we can offer

  • A dynamic and family friendly atmosphere with flexible working hours
  • Working with highly motivated professionals in international and interdisciplinary teams
  • A culture of independent thinkers embracing debate and initiative
  • Scientific excellence in research and development aiming to make a difference for patients in need
  • Flexible combination of onsite and remote work
  • Regular trainings with opportunities to grow
  • Attractive remuneration and company pension scheme
  • A wide range of offers in terms of health care and worklife balance

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