We are looking for a highly motivated senior scientist/principal scientist with Bioanalysis (LC-MS and/or Ligand Binding Assays (Gyros/MSD)) and pharmacokinetics knowledge, for a position as a preclinical PK expert. The candidate will be a key contributor to the preclinical pharmacokinetic strategy and will support its operational implementation in the DMPK department of Translational Medicine. The candidate is expected to promote, design, communicate and execute the relevant approaches in projects from the therapeutic areas of interest for the Servier group (Oncology and Neurology & Immuno-Inflammation mainly). This is a full-time position at our new R&D centre in Paris - Saclay with some home-based work (up to 8 days per month). The position is an individual contributor role which will not involve direct line reports. The position will report directly to the Head of Bioanalysis and non-clinical PK.
Missions:
- Support and challenge the elaboration of the early development plan for DMPK aspects of our drug candidates.
- Define and optimize the experimental design, and data interpretation of pharmacokinetic (PK), and toxicokinetic (TK) aspects of preclinical studies.
- Participate in project team meetings as a recognized Bioanalytical/PK expert
- Provide scientific leadership and training within the team as well as supported functions
- Write/Review protocols, scientific reports and SOPs
- Prepare the PK sections of both internal and regulatory documents (e.g. IND, IB and NDA)
- Provide PK/TK expertise for project strategic documents and study reports
- Proactively respond to study issues and resolve problems with study directors
- Follow external scientific advances in pharmacokinetics and promote and implement relevant technologies & methods internally to ensure state-of-the-art capabilities and continuous support for projects
- Ensure good communication with other partners in the project team and sub-teams (non-clinical safety, Pharmacology, Quantitative pharmacology, Clinical pharmacology, and formulation.
- Participate actively in operational performance monitoring by ensuring that resources and timelines are met for deliverables for which there is a contribution or accountability
- Interact with project leaders and different to align, plan and execute the adequate preclinical PK package.
- Summarize and present data packages to the project team for discussion.
- Actively interact and work closely with team members to establish requirements and work-plans to support the development of project-specific assays.
- Keep up with state-of-the-art practices/technologies and ensure appropriate methods are utilized to obtain maximum effectiveness for preclinical sample analysis, including identification, evaluation, and selection of relevant CROs.