Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
1. With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
2. Under direction, provide inputs to designing clinical pharmacology studies, protocol development, and provide support to study execution.
3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III studies.
4. Under direction, devise PK and PK-PD analysis plan and conduct analyses to describe PK in target patient population and explore PK-PD relationships to support dose selection for drug candidates in development.
5. With guidance, provide scientific oversight of CROs with respect to PK and PK/PD tasks.
6. Under direction, evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity to late stage Phase 3 drug development.
7. Under direction, conduct PK and PK-PD analyses and author reports to support global regulatory submission documents for compounds under drug development.
Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics and 0 to 2-years of experience conducting clinical pharmacology trials including analyzing and writing human pharmacokinetic studies.
Basic knowledge of pharmacokinetics and pharmacology concepts along with knowledge of principles of PK/PD data analyses, ie. population and exposure-response analyses.
Basic knowledge of the use of clinical pharmacokinetics for designing first-in-human studies and providing PK strategies for late phase registration studies.
Hands-on Software competency: NONMEM, R/S-Plus,WinNonlin , or equivalent and relevant modeling application.
Good knowledge of Microsoft Office Applications (Word, Excel, and PowerPoint).
Good written and oral communication and presentation skills.
Ability to work in a matrix, project-oriented environment.
Ability to organize and work simultaneously on multiple projects.
Not ready to apply?Join Our Talent Network
Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.