DMPK Project Lead

The individual will have projectresponsibility for early discovery towards candidate selection andinto the clinical phases of the development. They will beresponsible for the project aspects of nonclinical DMPK includingin vitro and in vivo activities preclinical PK translational PK andPKPD biotransformation and bioanalysis contributions to projects tofulfil internal and regulatory requirements up to and includingregistration.

What youlldo

• Designappropriate experimental studies and liaise with other areas of theRD organization to deliver data and interpretations to support theproject towards candidate selection andbeyond
• Have expert understanding of thedifferent approaches related to preclinical pharmacokinetics aswell as a good understanding of related disciplines (e.g.toxicokinetics nonclinical safety PKPD PK modelling drug designclinical DMPK bioanalytics andbiomarkers)
• Apply their understanding ofphysical properties DMPK and enzymology to input into the design ofnew compounds
• Work with the project andDevelopment Sciences colleagues to resolve or riskmitigateprojectrelated ADME challenges
• Work with otherareas in the DMPK organization to champion new innovativeapproaches to project support and ensure UCB stays at the forefrontof DMPK science
• Prepare the DMPK sections ofinternal and regulatory documents (e.g. IND IMPD IBNDA)
• Participate in research aligned to DMPKand UCBs portfolio to publish research papers in internationallyrecognized journals
• Provide scientificmentorship to support junior staff in their personaldevelopment

Interested For this rolewere looking for the following education experience andskills

• PhD(or equivalent) in Pharmaceutics Pharmacology Drug metabolism orPharmacokinetics with 7 years of PostDoctoral Industrialexperience; or a related degree with 10 years industrial experiencein DMPK science.
• A comprehensive understandingof discovery and development DMPK including modelling andsimulation and a proven ability to delineate the impact of chemicalstructure on measured properties
• Wideexperience in pharmaceutical RD including a knowledge of theregulatory requirements and experience working with regulatoryagencies to fulfil the DMPK contribution to new drugsubmissions
• A recognized track record ofexperience in DMPK/ADME and excellent knowledge inADME/Enzymology/Drug Transporters and knowledge of how to coupledata to optimization/selection of NCE both in discovery anddevelopment
• A proven track record of leadingunderstanding and handson experience of drug metabolism andpharmacokinetics both in vitro and in vivo studies human PKprediction DDI prediction and mechanistic understanding to supportlatestage programs
• Understanding of PKPD andpreferably an understanding of PBPKmodeling
• Proven skills for in depth mechanisticunderstanding of DMPK related issues and of the impact and value oftranslation to humans
• Knowledge of the drugdevelopment processes in the Pharma Industryenvironment.

Lifelancer() is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

/jobs/view/7d2133ddbdb4e602110f7018db411493

RemoteWork :

No