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Senior Toxicologist (m/f/d) in der Städteregion Aachen
Referenznummer: acjobs-st-68296

Grünenthal GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 12.10.2020


Grünenthal is a global leader in pain managementrelated diseases. We’re driven to seek effective, life-changing medicinessolutions for patients with severe diseaseshigh unmet medical needs. We’re focussing all of our activitiesefforts on moving towards our vision of a world free of pain. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatmentsstate-of-the-art technologies to people living with pain worldwide.
Grünenthal is headquartered in Aachen, Germany,has affiliates in 30 countries across Europe, Latin Americathe US. Our products are sold in more than 100 countries. In 2018, we employed around 4,900 peopleachieved sales of € 1.3 billion.
As a player in an innovative, fast-paced market, we offer an exciting working environmentwide-ranging individual development opportunities. Our sharedform the basis for the way we work: We embrace diversity, put patients at the centre of our decisions, live entrepreneurship,forces, drive performanceact with integrity. us at Grünenthal, unleash your full potentialhelp us change lives for the better. Job fact summary
Job ID: 37015
Senior Toxicologist (m/f/d)
Research & Development
published 08.10.2020
Senior Toxicologist (m/f/d)
You lead the developmentexecution of toxicology, safety pharmacology,other critical safety studies in support of Grünenthal´s R&D pipeline
You develop overall toxicology plans for lead candidates for Ph I to Ph III
You provide strategic guidance for project teams including evaluation of conclusionspotential impact of toxicology results on programclinical/ regulatory strategy
You lead the development of early hypothesis-driven investigationmechanisms of toxicity for the proactive management of potential safety liabilitiescommunication of impact to teams
You provide expert level guidance in designingimplementing preclinical toxicology studies at external contract research organizations (CRO)
You monitor toxicology studies; review, summarize, interpretintegrate complex data sets across multiple disciplines; finalize as submission-ready documents for regulatory authorities
You interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirementsguidelines related to pharmacology, toxicologynonclinical drug development in general
You characterize the toxicology profile of candidate moleculesprovide inputinvestigative studiesclinical starting dose strategies

You hold a PhD in Toxicologyclosely related field with several years’ experience in a drug discovery/ development setting of a biopharmaceutical company
You have a proven track record of making major contributions to the discovery of onemore marketedin-development medicines, incl. designing, monitoring,interpreting toxicology studies to support clinical development of candidate therapeutic agents
You have expert knowledge of nonclinical data packages needed to support first in human studies, clinical developmentproduct registration
You are familiar with more than one of the following therapeutic modalities preferred: smalllarge molecules, cellgene therapy
You have a theoreticalexperimental background in pathology, biology, DMPK coupled with a solid foundation in quantitative pharmacology
You have an understanding of the regulatory process including CMC, non-clinicalclinicalthe various stages of drug discoveryclinical development
You have expert knowledge of GLP regulationsexperience in the oversight of contracted studies

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