Clinical Pharmacokinetic Expert - Wuppertal, Deutschland - AiCuris Anti-infective Cures AG
Beschreibung
Your role will be to provide clinicalResponsibilities:
- 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.
- 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
- 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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