Pharmacometrics Lead (2411)

Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.

For our Clinical Pharmacology & Pharmacometrics Unit organization based at our Headquarters in Lausanne, we are looking for a

Pharmacometrics Lead

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 be the leader for developing the modeling and simulation strategy for projects in Oncology and Antibiotics, leveraging state-of-the-art PK and PK/PD methodologies, pharmacometry and Quantitative System Pharmacology (QSP). You will manage, conduct and supervise pharmacometrics activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine.

 

Your responsibilities will be but not limited to:

• Implement innovative quantitative methods to analyse non clinical and clinical data by modeling pharmacokinetics, pharmacodynamics, biomarkers and clinical outcomes data with information of patient characteristics, knowledge of disease mechanisms and disease progression to facilitate quantitative decision making in support to projects
• Elaborate and execute PK/PD modelling and simulation strategies in order to support model-informed drug development in early to late clinical phases of oncology and antibiotics projects
• Collaborates with Clinical Pharmacology and relevant functions within Translational Medicine and Research & Development to support study design, dose selection and optimization for small and large molecules under development
• Oversee the management of pharmacometrics activities of assigned projects, directly or through supervision of another pharmacometrician or external vendors, in compliance with regulatory guidelines
• Prepare the pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities
• Contribute and participate to scientific communications and events
• As part of Debiopharm’s model, contribute to the In & Out licensing activities

• PhD or equivalent degree in pharmaceutical sciences, mathematics, statistics, engineering or similar disciplines with demonstrated expertise in pharmacometrics (population PK and PK/PD modeling, exposure-response analysis, disease progression models, clinical trial simulation)
• Excellent programming skills (R, Python, …) and solid hands-on experience in Population PK/PD modelling softwares (NONMEM, Monolix, …); knowledge of PBPK modeling softwares (e.g.: SimCYP, PK-Sim, Gastro-Plus) is an asset
• In depth understanding of pharmacology and pharmacokinetic concepts, as well as preclinical and clinical development
• At least 7-year experience in pharmacometrics within Translational R&D and early clinical phases of drug development; experience in oncology; antibiotics is an asset
• Knowledge of GCP, GCLP and relevant regulatory guidelines
• You are used in working in cross-functional team and fast-paced environment
• Team player, looking to tackle challenges together with your team
• Excellent presentation capabilities and communication skills in English (oral and written), French is an asset

• 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
• 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.