Scientist Drug Metabolism & Phamacokinetics

Scientist Drug Metabolism & Phamacokinetics

GENFIT

Lille, France

As a member of the Research & Development team, the Scientist Drug Metabolism & Pharmacokinetics (PK) supports the preclinical and early development of drug candidates including pharmacokinetic/pharmacodynamic modeling (PK/PD), population Pharmacokinetic (popPK) Analysis. The Scientist serves as PK subject matter expert in the Project team to enable timely decision-making for early-stage programs and clinical development plans. The Scientist serves as a contact person interacting with key internal stakeholders providing technical and scientific directions in product pharmacokinetic (PK) to support study designs, clinical development plans, and regulatory submissions.

MISSIONS

Your responsibilities include, but are not limited to:

  • Conceptualizing and coordinating the execution of projects supportive of key development programs, and acts as the Drug Metabolism/PK representative on project team;
  • Providing scientific leadership in nonclinical, early and late clinical development to identify critical studies/experiments that will inform decision making for First in Human, Dose selection, Phase 1 study design, clinical development plans, and regulatory submission;
  • Ensuring adequacy of models to inform formulation design/optimization, population simulations, special populations, disease state modeling, Drug-Drug Interaction (DDI) predictions and clinical study designs;
  • Working with internal and external stakeholders for strategic planning, bioassay validation, logistics, sample processing, data generation;
  • Leading operational aspects of study execution (protocol development, study monitoring, data analysis, report writing, etc.) in collaboration with internal experts and external Contract Research Organizations (CROs)/vendors;
  • Advising on/validating (biomarker) bioanalytical strategies;
  • Authoring relevant sections of internal and regulatory submission documents for GENFIT products including but not limited to protocols, Investigation New Drug Application (IND), Clinical Trial Application (CTA), investigator brochure, New Drug Application (NDA);
  • Contributing to writing scientific communications including publications.

PROFILE

  • You hold a PhD or relevant post-doctoral training in Pharmaceutical Sciences, Clinical Pharmacology or Biological Sciences and have 5+ years of work experience in a similar role in the pharmaceutical industry;
  • Through your experiences, you have developed a good understanding of drug development processes and Non-clinical studies and have experienced PK and/or PK/PD modeling;
  • Your list of publications shows the extent of your writing and scientific abilities;
  • You are used to deal with shifting priorities, demands, and timelines; ability to promptly and efficiently react to project adjustments and changes;
  • You have developed strong interpersonal skills and the ability to elicit cooperation from a wide variety of stakeholders and to voice your viewpoints;
  • You have excellent communication skills (French and English) including written, oral and presentation within internal and external stakeholders;
  • You thrive in a fast-paced, international environment and you have the autonomy, flexibility and adaptability to work in a biotech company;
  • Self-starter, you have excellent planning and project management skills and demonstrated ability to properly set priorities.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

France     Clinical Research     Pre-clinical Research and Development     GENFIT    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies