Pubblicato il 14/09/2021
Pharma & Medical Devices
For our Client, a worldwide Contract Research Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects.
We are looking for a:
SCIENTIFIC PROJECT LEADER (SPL) – CMC TOXICOLOGY
The Scientific Project Leader (SPL) is accountable for the scientific management of drug development integrated projects which start after indentification of potential drug candidate. The SPL will be involved about integrated project defined as multi-departmental work packages including CMC and/or Pre-clinical functions in supporting to clinical trials (from Phase I up to Phase III). These projects may also include de-risking packages designed to further characterize the drug candidate when transitioning from discovery before starting the full development to reduce risk of failure during the next phases.
·Degree in Pharmacy, Biology or Biochemistry, PhD desirable;
·Excellent knowledge & expertise in pharmaceutical R&D and in particular in preclinical (toxicologyand ADME) including US and EU regulatory requirements in supporting different development phases;
·Huge experience as study director and/or monitor of general toxicity and safety pharmacology studies either as non GLP and GLP. The practical preclinical experience demonstrated when working with compounds having different mechanism of actions, different therapeutic indications being organic compounds (small molecules) or biologics (i.e. peptides, proteins, oligonucleoditesand monoclonal antibodies);
·At least 7-10 years of experience in the pharmaceutical industry where she/he worked as a study director/monitor for GLP and non-GLP in vitro and in vivo toxicological studies (preferable ingeneral toxicity) with a deep knowledge in data interpretation including pharmacokinetic/toxicokinetics;
·At least 5 years of experience in more senior roles requiring management of integrated programs being representative of preclinical area and responsible of preclinical package (ADME and Safety assessment) in supporting to clinical trials (i.e. Phase I and Phase II) according to regulatory requirements, acting as technical project leader, scientific leader, preclinical expert, etc.
Location: Italy – Home Based or Verona Area
Wyser è la società internazionale di Gi Group che si occupa di ricerca e selezione di middle e senior management specializzato.Facciamo parte di Gi Group, una delle principali realtà a livello internazionale nei servizi dedicati allo sviluppo del mercato del lavoro.
I candidati ambosessi (D.lgs. n. 198/2006), sono invitati a leggere l’informativa privacy ai sensi degli artt. 13 e 14 del Reg. EU 679/2016 al seguente indirizzo: https://it.wyser-search.com/privacy-candidati/
Wyser (Aut. Min. del 15/04/2014 Prot. N: 39/4903)
Pharma & Medical Devices
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