P2621 - (Senior) Pharmacometrician

Poste

Permanent

Senior

Science & Recherche

Modalités

Lausanne, Switzerland

Exigences

3+ ans d'exp.

Doctorat

Permis UE/AELE

Compétences

Gastro-PlusPK-SimPharmacometric analysisSimCYPPK/PD modeling softwareEfficacy modelingNONMEMPythonMonolixGCPGLPRegulatory frameworks

Langues

Anglais C1

Français

Description

In this role, you will contribute to the modeling and simulation activities for projects in Oncology and Antibiotics, leveraging state-of-the-art PK,PK/PD and other methodologies. You will conduct pharmacometrics analyses to add value, support, and accelerate the development of Debiopharm’s innovative medicine.

Responsabilités

Performing (hands-on) and/or monitoring (oversight) pharmacometrics (PMx) activities from non-clinical to clinical drug development stages of primarily oncology programs.
Conduct relevant modeling and simulation activities in compliance with regulatory guidelines and internal SOP, including but not limited to: POPPK, PK/PD, ER, disease progression modeling, trial simulation, model-based optimal trial design, documentation.
Contribute to developing, implementing and promoting innovative PMx methodologies.
Contribute to developing and executing the model-informed drug development strategies from early to late development stages.
Communicating on PMx results in a cross-functional environment.
Contribute to the preparation of PMx documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities.
Contribute to external scientific communications (publications, posters and oral presentations, and press releases).
Participate in external scientific forums, conferences and courses to stay updated with latest industry trends and establish professional networks.
Supports the In & Out licensing activities as part of Debiopharm’s model.

Exigences

PhD or equivalent degree in Pharmacometrics, mathematics, statistics, or similar disciplines with demonstrated expertise in pharmacometrics (e.g., population PK and PK/PD modeling, exposure-response analysis, disease progression models, clinical trial simulation).
At least 3-5 years relevant experience in PMx within industry or academia; experience in oncology is an asset.
Solid hands-on experience in Population PK/PD modelling software (Monolix, NONMEM); Excellent programming skills (R, Python, …); Knowledge of PBPK modeling software (e.g.: SimCYP, PK-Sim, Gastro-Plus) is an asset.
In depth understanding of pharmacology and pharmacokinetic concepts, as well as knowledge of preclinical and clinical development.
Knowledge of GCP, GCLP and relevant regulatory guidelines.
Ability to work independently in a fast-paced environment while maintaining strong collaborations both within and cross functions.
Strong organizational skills and ability to handle multiple tasks simultaneously.
Results interpretation capabilities, strong scientific/technical writing/reporting abilities, and interpersonal skills in English, French is an asset.

Technologies

MonolixNONMEMRPythonSimCYPPK-SimGastro-Plus

Avantages

International, highly dynamic environment with a long-term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
Opportunity of personal development through specific trainings and attendance to scientific conferences.
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.

Entreprise

Debiopharm

Pharmaceuticals

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficacy is our mode of action, saving lives our collective target.