Associate Director Clinical PharmacologyPharmacokinetics (m/f/d) in der Städteregion Aachen
PAION Deutschland GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 06.11.2019
PAION is a publicly listed specialty pharmaceutical company developingaiming to commercialize innovative drugs for out-patienthospital-based sedation, anesthesiacritical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-actingcontrollable benzodiazepine sedative/anesthetic drug candidate for which PAION has completed the clinical development for use in procedural sedation in the U.S.its local licensee Cosmo Pharmaceuticals submitted a New Drug Application in April 2019. In Japan, licensee Mundipharma filed for market approval for remimazolam in general anesthesia in December 2018.
In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018. In Europe, PAION is seeking approval for remimazolam in the indications general anesthesiaprocedural sedation. For the development of remimazolam in general anesthesia, PAION is currently conducting a Phase III trial in Europe. The submission of a Marketing Authorization Application in procedural sedation in the EU is planned based on the U.S. development program.Development of remimazolam for intensive care unit (ICU) sedation is part of the longer-term life-cycle plan for remimazolam.PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
For our team in Aachen we are currently searching for an
Associate Director Clinical PharmacologyPharmacokinetics (m/f/d)
as maternity cover limited for two years.
Designexecute/outsource pharmacokinetic investigations eg PK(/PD) modeling, PK analysis of clinical trials, in-vitro investigations,
Analyses of clinicalnon-clinical data
Be the company key expert for all clinicalnon-clinical pharmacokinetic questions, both internallywith regulatory authorities, advisory boardskey opinion leaders
Be responsible for all Clinical Pharmacology modules of submission documents
Design clinical pharmacologypharmacokinetics trials
PhD in biomedicalnatural sciences, MD
At least 3 years experience in biopharmaceutical industry in a similar role
Basic knowledge of PK-PD and/or PBPK modelingthe software used eg NONMEM, WinNonlin
Good knowledge of pharmacokinetics
Working knowledge of biostatistics
Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-42591an.