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Director Clinical Pharmacology

Req #: 1701171
Location: San Diego, San Diego US
Job Category: Research and Early Development
Work Location: 3033 Science Park Road Suite 300 RCPTSD 92121
Organization: Receptos, Inc.
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- CA- San Diego- Science Park

Description

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.

This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address significant unmet medical needs. The Director, Clinical Pharmacology will focus on designing and executing appropriate clinical pharmacology strategies for all assets in the company portfolio, which includes small molecules and biologics. She/he provides expertise in clinical pharmacology supporting assessment of absorption, distribution, metabolism, and excretion (ADME) property and drug-drug interactions across all phases of drug development. She/he collaborates with other key functions, including Translational Medicine, Preclinical Development, Clinical Development, Clinical Operations, Regulatory and CMC and to maximize the efficiency and effectiveness of the drug development programs.

Major Responsibilities:

  • Plan and execute clinical pharmacology studies
  • Provide strategic direction and/or hands-on support to the writing and review of study synopses, protocols, and clinical study reports
  • Perform data analyses including NCA, population PK and exposure-response
  • Work with statisticians and team members to interpret and report study results
  • Contribute to the regulatory submission packages, and participate in regulatory meetings as appropriate
  • Collaborate with Preclinical Research and Translational Medicine on biomarker strategies and preclinical model selection and study design
  • Serve as a clinical study team leader for clinical pharmacology studies
  • Articulate clinical pharmacology plans and study results to development teams and/or senior management
  • Present study results at scientific conferences and in scientific journals
  • Other responsibilities as assigned

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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.
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About Celgene

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.

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