DMPK Consultant (BBBH12561) Hessen, Germany

Aplitrak - Hessen - 17-10-2019 zur Vakanz  

Hobson Prior are looking for a DMPK Consultant to join a leading science and technology organisation who are driven to help improve and prolong life. This position will join them on a contract basis, located in Hessen and will be accountable for consulting in the field of DMPK projects.

Job Responsibilities:

  • Deliver strategic advice and design ideas to allow rational drug development of small molecules
  • Consulting cross-functional global project teams, in the area of:
  • Candidate responsibility in pre-clinical, first in human, proof of concept through to late development
  • Products in post marketing phases of clinical development and established products
  • Preparing of/consulting in first in human needs and best practice study design and preparation of global clinical pharmacology strategy and development plans
  • Preparing clinical risk assessments based on animal safety data and calculation of human safe starting dose.
  • Responsible for consulting in:
  • Designing, planning, conducting, analysing (data analysis and bioanalysis) and interpreting in vivo and in vitro ADME, PK, toxicokinetic and PK/PD studies.
  • Bioanalysis requirements to support regulatory standard preclinical and clinical sample analysis
  • Evaluating external in-licence and outsourcing opportunities of small molecules and biologics.
  • Managing (scientific and planning) of studies conducted at external CROs.
  • Authoring pre-clinical DMPK and clinical aspects of IND’s and CTA’s, Regulatory Briefing Documents, Investigational Brochures, Investigational Medicinal Product Dossiers and dossier updates for established products, Common Technical Documents, IND annual reports, Type-II variations, Clinical Study Synopses and protocol sections, Clinical Study Reports, Paediatric Investigation Plans and responses to competent regulatory agencies.
  • Overseeing PK (Phoenix/Winonlin) and PBPK (Simcyp TM) modelling directed at understanding clinical PK, PKPD, paediatric PK modelling and prediction of human PK and dose.
  • you will evaluate in-licensing opportunities and carry out due diligence activities for small molecule.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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