Clinical Pharmacology (Senior) Lead - France
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- We are looking for several candidates with 5 to 15 years experience to strengthen our Clinical Pharmacology group.
- Within the Clinical Pharmacology group, you will contribute to the characterization of pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates.
Your principal accountabilities will be:
- Management and monitoring of the outsourced PK and PD activities in support to clinical development plan
- Analyzing, interpreting and reporting PK/PD data from clinical studies
- Collaborating and guiding the Clinical team to set-up, data analysis and reporting for clinical studies.
- Preparing and/or reviewing PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IB, IND, NDA and other regulatory documents)
- Represent the Clinical Pharmacology group on multi-disciplinary Development Project Teams, providing appropriate PK/PD input and contribution to solve potential PK/PD issues and ensure timely and efficient progression of projects.
- Actively preparing, reviewing and publishing scientific papers and abstracts
- a PhD or Master in relevant disciplines (PK, PD)
- at least 5 years’ experience in Clinical Development in Pharmaceutical Industry or Contract Research Organizations
- a strong understanding of pharmacokinetics and pharmacodynamics (PKPD) principles..
- Hands-on experience PK/PD software packages (Phoenix)
- You have the capability to work as an expert and share your expertise with other team members.
- You know how to work independently and within a team.
- You are used to work in project mode, including with geographically distant teams.
- Your reactivity allow you to handle short delay and high pressure in competitive projects.
- You have a good written and oral communication, both in English and French.