Celgene Senior Scientist, Clinical Pharmacology & Pharmacokinetics in Summit, New Jersey

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.

Responsibilities include:

  1. Perform non-compartmental pharmacokinetic (PK) data analysis using WinNonlin and interpret PK data.

  2. Provide clinical protocol design input of PK and PD investigation and assist in the clinical study execution logistics

  3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III PK and PK/PD studies

  4. Assist in the development of the statistical analysis plan

  5. Assist in the analysis and reporting population-pharmacokinetic and PK/PD data

  6. Manage CROs to conduct analysis and report PK and PK/PD data

  7. With guidance, evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity, and to late stage Phase 3 development

  8. With guidance, provide inputs to PK and PK/PD strategies to compounds under drug development for global regulatory submission.

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Qualifications

Skills/Knowledge Required:

Advanced degree (Pharm.D. or Ph.D.) in pharmacokinetics/pharmacology or relevant life sciences, with a minimum of 6-years’ experience conducting and analyzing pharmacokinetic studies in humans.

  1. Work with multiple studies/programs with moderate to limited oversight

  2. Sets own priorities with some guidance

  3. Keeps manager and key stakeholders informed on programs to assure alignment

  4. Thorough knowledge of the global drug dev. process and key deliverable by multiple functions in collaboration from discovery to commercialization

  5. Through and in depth knowledge of PK/PD and its application and impact on drug development

  6. Thorough understanding of ADME principles in drug development

  7. Good document authoring and review/edit skills

  8. Work with multiple studies/programs with moderate to limited oversight

  9. Sets own priorities with some guidance

  10. Keeps manager and key stakeholders informed on programs to assure alignment

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.

Senior Scientist, Clinical Pharmacology & Pharmacokinetics

Location: Summit, NJ, US

Job ID: 17000970