Celgene Director, Clinical Pharmacokinetics in Summit, New Jersey
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.
Serve as the department delegate for clinical pharmacokinetics & clinical pharmacology in clinical study and project teams.
Supervise and/or perform non-compartmental pharmacokinetic (PK) data analysis using WinNonlin and interpret PK data.
Plan, implement, interpret and report PK and PK/PD investigations in Phase I, II, III and IV studies
Supervise and/or perform meta-analysis of population PK and PK/PD data
Manage CROs to conduct meta-analysis and report PK and PK/PD data
Evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity, and to late stage Phase 3 development
Set PK and PK/PD strategies for compounds under drug development for global regulatory submission
Supervise and/or prepare the eCTD dossiers of sections 2.5, 2.7.1 and 2.7.2 for NDA submission
Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics and a minimum of 10-years’ experience analyzing preclinical and clinical pharmacology studies.
Expert understanding of the global drug dev. process and collaborations among multiple functions from discovery to commercialization. In-depth knowledge of the drug development process, GLP and GCP.
Expert knowledge and experience in PK/PD and pharmacometric applications in all phases of clinical dev. process, PK/PD data compilation and manipulation with scripting softwares of SAS, R and/or Splus.
Expert knowledge of drug disposition and clinical pharmacology characterization of drugs
Advanced scientific writing skills to explain complexity with clarity
Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects
Network with stakeholders in shaping project development
Successfully manages team conflict(s) to resolution and improves team collaboration
Organizes and provides assistance to departmental training
Contributes to multidisciplinary task force to support continuous improvement
Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance)
Up-to-date with new scientific development
Anticipates and proactively address issues/problems on projects and study teams
Recommends solutions to project and study teams
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.
Director, Clinical Pharmacokinetics
Location: Summit, NJ, US
Job ID: 17001874