Debiopharm
Senior Clinical Data Manager(m/w/x)
Full-timeOn-siteSenior
Lausanne
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DEDebiopharm
Principal Clinical Pharmacologist(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Designing clinical pharmacology studies for oncology and infectious disease therapies. Expertise in pharmacometrics and regulatory guidelines required. Exposure to clinical development and pharmaceutical industry.
Requirements
- PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or related discipline
- Expertise in Pharmacometrics (Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation)
- Excellent knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines
- Experience in Antibody Drug Conjugate development is an asset
- Experience working in cross-functional teams and fast-paced environment
- Team player, tackling challenges together with team
- Excellent communication skills in English (oral and written), French is an asset
Tasks
- Develop clinical pharmacology strategy for assigned projects
- Collaborate with project teams on clinical pharmacology activities
- Design clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug interactions, PK in special populations)
- Elaborate pharmacometrics strategy with pharmacometricians
- Organize pharmacometrics activities for assigned projects
- Contribute to protocol writing for clinical trials
- Manage PK and PK/PD analyses and reporting
- Assess and manage risks of food-drug and drug-drug interactions
- Oversee outsourced clinical pharmacology activities
- Prepare clinical pharmacology and pharmacometrics documentation
- Support regulatory and cross-functional activities
- Participate in interactions with Health Authorities
- Contribute to scientific communication and events
- Participate in In & Out licensing activities
- Support external fundraising activities
Work Experience
- 7 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
- French – is a plus
Tools & Technologies
- Non-Compartmental PK analysis
- Population PK/PD
- Modeling & Simulation
- GCP
- GCLP
- GLP
- Antibody Drug Conjugate
Benefits
Informal Culture
- International and dynamic environment
- People focus
Other Benefits
- Long-term vision
- Opportunity to join successful company
- Exposure to clinical development
- Exposure to pharmaceutical industry
Startup Environment
- Innovation focus
- Entrepreneurship focus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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DEDebiopharm
Principal Clinical Pharmacologist(m/w/x)
Lausanne
Full-timeOn-siteSenior
Nejo AI Summary
Designing clinical pharmacology studies for oncology and infectious disease therapies. Expertise in pharmacometrics and regulatory guidelines required. Exposure to clinical development and pharmaceutical industry.
Requirements
- PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or related discipline
- Expertise in Pharmacometrics (Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation)
- Excellent knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines
- Experience in Antibody Drug Conjugate development is an asset
- Experience working in cross-functional teams and fast-paced environment
- Team player, tackling challenges together with team
- Excellent communication skills in English (oral and written), French is an asset
Tasks
- Develop clinical pharmacology strategy for assigned projects
- Collaborate with project teams on clinical pharmacology activities
- Design clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug interactions, PK in special populations)
- Elaborate pharmacometrics strategy with pharmacometricians
- Organize pharmacometrics activities for assigned projects
- Contribute to protocol writing for clinical trials
- Manage PK and PK/PD analyses and reporting
- Assess and manage risks of food-drug and drug-drug interactions
- Oversee outsourced clinical pharmacology activities
- Prepare clinical pharmacology and pharmacometrics documentation
- Support regulatory and cross-functional activities
- Participate in interactions with Health Authorities
- Contribute to scientific communication and events
- Participate in In & Out licensing activities
- Support external fundraising activities
Work Experience
- 7 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
- French – is a plus
Tools & Technologies
- Non-Compartmental PK analysis
- Population PK/PD
- Modeling & Simulation
- GCP
- GCLP
- GLP
- Antibody Drug Conjugate
Benefits
Informal Culture
- International and dynamic environment
- People focus
Other Benefits
- Long-term vision
- Opportunity to join successful company
- Exposure to clinical development
- Exposure to pharmaceutical industry
Startup Environment
- Innovation focus
- Entrepreneurship focus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Debiopharm
Industry
Pharmaceuticals
Description
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
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