- Clinical Research
ADME Expert (m/f)
Currently I am looking for a ADME Expert, anti-CEACAM5 ADC to support a German global pharma company in Darmstadt for 11 months. The position is full-time based and 100% remote.
Estimated hour breakdown: ~40 hr per week for the first month, gap of 1 month, ~5 hr per week during trial execution (6 mo), ~20 hr per week for 2 months to wrap up the study reports. Travel to other sites of the company is reimbursed.
End: 31.05. 2019 (extension option : 01.07.2020)
Scope of Work:
- Provide subject matter expertise on absorption, metabolism, distribution, and excretion (ADME) properties of Antibody-drug conjugate (ADC)
- Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals to predict, understand, and optimize ADME properties of ADCs
- Design (in vitro/in vivo) ADME and PK studies for pre
-clinical IND enabling studies (and later for clinical studies) of ADCs
- Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME studies.
- Provideanalysis, interpretation, integrationandreportingofpreclinical DMPKdatageneratedbothinternallyandwithexternalvendors/academicsites
- Author high quality regulatory documents.
- Review Sponsor protocols, reports, regulatorydocuments, projectplansandothertechnicaldocumentsfortheassignedADCprojects
Who you are:
* Proven experience in all aspects of Antibody drug conjugates (ADC)
* Requiressubstantialprofessionalexperiencewith Health authorityinteractions
* Experiences in drugdispositionarenicetohave
* Very good oral and written communication skills in English
Should you fulfil the above requirements and have interest in the role, please reply with an updated CV in word doc format to v.doell(at)realstaffing.com .
Additionally, feel free to share this job alert with your personal network.
I am looking forward to your application.
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