Manager Drug Metabolism and Pharmacokinetics Modelling

140968
  • Competitive
  • Lille, France
  • Permanent

As Manager, DMPK and PK/PD Modeling, you will lead our Drug Metabolism and Pharmacokinetics (DMPK) activities. In this role you will have the opportunity to develop scientific strategies, leveraging your knowledge in ADME concepts, pharmacokinetics (PK), pharmacodynamics (PD), PK/PD modeling and bioanalytical principles to further advance our non-clinical and clinical development stage programs. Together with your team, you will drive the quality and performance of all DMPK activities. You will work cross-functionally with translational and clinical research to meet regulatory requirements as molecules in early development progress to later phases of clinical trials.

Location: flexible (Lille – France; Paris – France)

 

MISSIONS:

Your responsibilities include, but are not limited to:

  • Design and lead the execution of Drug Metabolism and Pharmacokinetic (DMPK) studies to evaluate the ADME and Pharmacokinetic (PK) properties supporting the progression of drug candidates into the clinical phase;
  • Oversee the analysis, interpretation, and reporting of DMPK studies (including Drug-Drug Interactions) throughout preclinical and clinical drug development;
  • Conduct hands-on PK and PK/PD analysis based on compartmental, non-compartmental and population PK approaches using non-clinical and clinical data;
  • Use modeling and simulation to predict human exposure/efficacious dose that will inform decision making for formulation design/optimization, First in Human dose selection, target patient population, disease state, Drug-Drug Interaction (DDI) predictions and clinical study designs, and regulatory strategy;
  • Manage bioanalytical teams to implement and validate bioanalytical methods, to manage sample analysis and interpret data, and to develop data transfer plans;
  • Work closely with other departments, such as research, toxicology and clinical, regulatory to ensure a coordinated approach to drug development;
  • Contribute to the preparation of regulatory documents including Investigator’s Brochure, INDs, CTAs, and NDA filings;
  • Manage internal and external collaborations and resources including interactions with CROs and internal projects stakeholders;
  • Ensure compliance with industry regulations and standards in all DMPK activities;
  • Define and assign resources and budget to all DMPK projects;
  • Initiate and lead collaborations with academic sites and participate in the preparation of abstracts and manuscripts for publication.

 

PROFILE:

  • PhD in a relevant field, such as Pharmacokinetics, Pharmacology, Biochemistry, modeling and simulation or related discipline;
  • Significant experience in the pharmaceutical or biotechnology industry (at least 15 years), with a focus on DMPK;
  • In depth knowledge and hands-on experience in contemporary PK, population PK, PB/PK, data analysis, and interpretation; demonstrated record in applying these concepts to support clinical development programs;
  • Proven leadership and management skills;
  • Excellent written and verbal communication skills, including a good command of the English language (fluency in the French language is a plus);
  • Ability to work in a fast-paced, team-oriented environment;
  • Strong knowledge of relevant regulations and industry standards.

 

Max Trafford Client Partner

Apply for this role

Not registered? Create your account or if you already have an account? Sign in here

Meet Recruitment 2022. Meet Recruitment Ltd., Meet Recruitment Inc. and Meet Personalberatung GmbH are all subsidiaries of Meet Group (No. 13556131) a company registered in England and Wales at Irongate House, 22-30 Dukes Place, London, EC3A 7LP.
Site by Venn