Dear all,
Sanofi R&D is seeking a senior pharmacometrician to lead the Modeling & Simulation Unit of Paris operational centre. The candidate, as a Member of Drug Disposition leadership team, will be responsible for:
Job Responsibilities/Department Description
* Leading a team of pharmacometricians to support projects in oncology and other therapeutic areas in the planning, execution interpretation and prediction of exposure-response analyses for drug development programs across all Phases.
* Working closely with the global senior scientific advisors on M&S strategies to ensure project team needs are appropriately addressed.
* Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon best practices (i.e. model-based drug development).
* Working and communicating effectively with people from diverse scientific backgrounds in multi-disciplinary development teams providing pharmacometric/modeling expertise in different therapeutic areas.
* Co-ordinating analyses of pharmacometrics data from preclinical activities to support the selection of appropriate candidate compounds for clinical development, and characterization of the popPK and PK/PD of projects spanning Phase I to Phase IV and life-cycle management.
* Responsible for designing and analyzing the pharmacokinetic and pharmacodynamic components of clinical trials in all phases of development.
* Ensuring quality of the study protocols, reports, sections of reports (e.g., INDs and NDAs) required for regulatory submissions to various health authorities (e.g., the FDA and EMA), summaries and publications.
* Implementing innovative quantitative methods to integrate data of pharmacokinetics, biomarkers, and clinical outcome with data of patient characteristics and knowledge of disease mechanisms and disease states to facilitate quantitative decision making.
* Working in compliance with good clinical Practice (GCP) regulations and guidance of regulatory authorities.
* Responsible for resource planning, management and administration
* Develops and supports external contacts (investigators, academic and regulatory community, partners in collaborations).
Qualifications
Requirements/Skills
* PhD in relevant scientific discipline and demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modelling/systems pharmacology, quantitative translational scaling, population modelling).
* Understanding of DMPK and pharmacology/ safety aspects of drug discovery and clinical development, and of basic statistics.
* At least 10 years of experience on modelling and simulation in drug development in the pharmaceutical industry
* Extensive experience leading a team, managing and developing scientists.
* Excellent written and verbal communication skills, with successful presentation capabilities.
* Excellent team work and strong communication in a multidisciplinary environment
* Innovative and critical thinking. Customer focus. Process and performance oriented constant drive to improve working practice.
Languages:
Fluent French and English (oral and written)
To apply, please send your CV with references and a letter of motivation to christine.mauriac_at_sanofi.com<mailto:christine.mauriac_at_sanofi.com> or dany.renier_at_sanofi.com<mailto:dany.renier_at_sanofi.com> or directly apply on the Sanofi website.
Christine Veyrat-Follet, PhD
Senior Pharmacometrician position at Sanofi
Dear all,
Sanofi R&D is seeking a senior pharmacometrician to lead the Modeling &
Simulation Unit of Paris operational centre. The candidate, as a Member of Drug
Disposition leadership team, will be responsible for:
Job Responsibilities/Department Description
* Leading a team of pharmacometricians to support projects in oncology
and other therapeutic areas in the planning, execution interpretation and
prediction of exposure-response analyses for drug development programs across
all Phases.
* Working closely with the global senior scientific advisors on M&S
strategies to ensure project team needs are appropriately addressed.
* Accountable for the development and implementation of a clinical
modeling and simulation plan based on agreed upon best practices (i.e.
model-based drug development).
* Working and communicating effectively with people from diverse
scientific backgrounds in multi-disciplinary development teams providing
pharmacometric/modeling expertise in different therapeutic areas.
* Co-ordinating analyses of pharmacometrics data from preclinical
activities to support the selection of appropriate candidate compounds for
clinical development, and characterization of the popPK and PK/PD of projects
spanning Phase I to Phase IV and life-cycle management.
* Responsible for designing and analyzing the pharmacokinetic and
pharmacodynamic components of clinical trials in all phases of development.
* Ensuring quality of the study protocols, reports, sections of reports
(e.g., INDs and NDAs) required for regulatory submissions to various health
authorities (e.g., the FDA and EMA), summaries and publications.
* Implementing innovative quantitative methods to integrate data of
pharmacokinetics, biomarkers, and clinical outcome with data of patient
characteristics and knowledge of disease mechanisms and disease states to
facilitate quantitative decision making.
* Working in compliance with good clinical Practice (GCP) regulations
and guidance of regulatory authorities.
* Responsible for resource planning, management and administration
* Develops and supports external contacts (investigators, academic and
regulatory community, partners in collaborations).
Qualifications
Requirements/Skills
* PhD in relevant scientific discipline and demonstrated expertise in
pharmacometrics and strong quantitative skills (e.g. experience in mechanistic
modelling/systems pharmacology, quantitative translational scaling, population
modelling).
* Understanding of DMPK and pharmacology/ safety aspects of drug
discovery and clinical development, and of basic statistics.
* At least 10 years of experience on modelling and simulation in drug
development in the pharmaceutical industry
* Extensive experience leading a team, managing and developing
scientists.
* Excellent written and verbal communication skills, with successful
presentation capabilities.
* Excellent team work and strong communication in a multidisciplinary
environment
* Innovative and critical thinking. Customer focus. Process and
performance oriented constant drive to improve working practice.
Languages:
Fluent French and English (oral and written)
To apply, please send your CV with references and a letter of motivation to
[email protected]<mailto:[email protected]> or
[email protected]<mailto:[email protected]> or directly apply on
the Sanofi website.
Christine Veyrat-Follet, PhD