Pharmacometrician Director
Il y a 4 mois
**Define and implement the Pharmacometrics Plan for New Chemical Entities (NCE) and New Biological Entities (NBE) to support registration dossiers**
- Develop the PMx strategy and contribute to modeling and simulation activities for non-clinical and clinical development projects.
- Identify opportunities for MIDD to enhance project support.
- Optimize study designs and inform drug development strategies for decision-making and successful approvals.
**Performing (hands-on) and/or monitoring (oversight) Pharmacometrics (PMx) activities from non-clinical to clinical drug development stage**
- Conduct modeling and simulation activities, including but not limited to population pharmacokinetics/pharmacodynamics (PK/PD), exposure/response, disease progression modeling, and mínimal PBPK.
- Support the design of non-clinical and clinical trials using simulation and/or optimal design methods.
- Develop, implement, and promote innovative PMx methodologies and approaches.
- Stay updated with new PMx approaches.
- Plan, budget, and execute subcontracted PMx activities (PK/PD and/or PBPK).
**Contributing to all PMx documentations**
- Ensure the timely delivery and quality of PMx documents (e.g., dataset specifications, analysis plans, and reports).
- Collaboratively write and review key documents where PMx is a co-author (e.g., clinical development plans, pediatric investigational plans, submission documents).
**Communicating on PMx results and how PMx could support all drug development**
- Represent the PMx group in project teams.
- Interact with cross-functional teams (e.g., early development, pharmacology, biometry).
- Participate in internal and external initiatives/working groups.
- Conduct external presentations and contribute to publications.
**EHS responsibilities**:
- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system
- Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
- Ensure the completion of mandatory EHS training
**#LI-Hybrid**
LI-MC1