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. Serve as the department lead person for clinical pharmacokinetics in study and project teams.
2. Perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
3. Provide protocol study design input and assist in the development of clinical study monitoring plans, site selection, and PK samples logistics.
4. Plan, implement, interpret and report of assigned Phase I to III PK and PK/PD studies.
5. Analyze and report population-pharmacokinetic and PK/PD data as necessary to describe pharmacokinetics in patient population,
6. 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. Provide PK and PK/PD strategies to compounds under drug development for global regulatory submission.
8. Assist in the development of the statistical analysis plan.
9. Scientific oversight of CROs with respect to PK and PK/PD tasks.
Advanced degree (Pharm.D. or Ph.D.) in pharmacokinetics/pharmacology or relevant life sciences, with a minimum of 5-years experience conducting and analyzing pharmacokinetic studies in humans.
? Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics 5-years of experience conducting clinical pharmacology trials including analyzing and writing human pharmacokinetic studies.
? Knowledge of pharmacokinetics and pharmacology concepts, and experience with PK/PD data analyses, ie. population and exposure-response analyses.
? Knowledge of drug development process.
? Good understanding of the use of clinical pharmacokinetics for designing first-in-human studies and providing PK strategies for late phase registration studies.
? Computer literate: familiarity with WinNonlin? or equivalent.
? Good knowledge of Microsoft Word, Excel, and PowerPoint.
? Good written and oral presentation skills.
? Ability to work in a matrix, project-oriented environment
? Ability to organize and work simultaneously on multiple projects.
? Knowledge and experience of clinical data base, PK/PD data compilation and manipulation with scripting software of NONMEM, SAS, Splus and/or R a plus
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Req ID: 15001144
Primary Location: United States-New Jersey-Summit
Job: Research and Development
Organization: Celgene Corporation
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Job Posting: 2015-05-27 00:00:00.0
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