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Manager, Clinical Pharmacology Trials

Req #: 17001631
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 25 % of the Time
Other Locations:US- NJ- Summit West

Summary/Scope

The Manager, Clinical Pharmacology Trials, is responsible for the day-to-day operational management and general scientific input for global Phase 0/1 clinical pharmacology trials, from protocol writing through final clinical study reporting.  Excellent organizational, managerial, and interpersonal skills are required.  Experience in managing various types of clinical pharmacology studies is essential.   Understanding of basic pharmacokinetic principles, data collection methods, and statistical analyses is preferred.  The candidate must have strong project and time management skills and be able to function with some/minimal guidance.  The candidate should have the ability to identify rate-limiting issues, anticipate problems, and to effectively communicate with the appropriate parties, offering proactive resolutions.  Ability and willingness to work within a matrix environment and ability to function as representative on project teams as required.    

Education and Experience: 

  • Bachelor’s Degree (life science preferred) with biopharmaceutical industry experience of 10 or more years, and clinical pharmacology experience of 7 or more years. -
  • Master’s Degree (life science preferred) with biopharmaceutical industry experience of 6 or more years, and clinical pharmacology experience of 3 or more years. Responsibilities:
  • Manage clinical pharmacology studies (US and ex-US) and individual study teams.
  • Track progress of assigned studies/programs and report updates to management. When applicable, assess rate limiting issues, and apply resolutions in a proactive manner.
  • Review study budgets, contracts, and work orders. - Interact with thought leaders, investigators, internal, external customers, etc., to move studies/programs forward in alignment with departmental and company objectives. 
  • Evaluate external vendors and potential clinical sites for various clinical pharmacology studies.
  • Conduct all aspects of study management, from study start-up through report finalization. - Maintain study-related documentation as per Celgene SOPs and GCP requirements.
  • Participate in departmental and company-run initiatives to support continuous business improvements. 
  • Author and review abstracts/manuscripts, etc., for presentation/publication at internal/external meetings. 
  • Travel required – approximately 25 to 40%

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