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. 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. Your responsibilities will be but not limited to: 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. RequirementsYour profile 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, …);KnowledgeKnowledge 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 wring/reporting abilities, and interpersonal skills in English, French is an asset.BenefitsDebiopharm offers employees: 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 The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm. Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
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.
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.
Your responsibilities will be but not limited to:
- 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.
Requirements
Your profile
- 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, …);KnowledgeKnowledge 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 wring/reporting abilities, and interpersonal skills in English, French is an asset.
Benefits
Debiopharm offers employees:
- 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
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups. Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).
We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups.
Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
