Director, Clinical Pharmacology & Pharmacometrics

BeOne Medicines Ltd

US Remote or Hybrid with Wednesdays in our San Carlos, CA Office
$174,000.00 - $234,000.00 annually; annual bonus p...
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Clinical pharmacology and pharmacometrics strategies
Characterize pharmacokinetic profiles
Dose selection justification
** BeOne Medicines Ltd is seeking a Director of Clinical Pharmacology & Pharmacometrics, responsible for developing strategies for clinical pharmacology and pharmacometrics for oncology drug candidates. The role emphasizes collaboration across various functions and strong regulatory knowledge, with a focus on innovative techniques in drug development. **

Job Summary

  • Develop and execute clinical pharmacology and pharmacometric strategies for novel small molecules and biologics assets.
  • Provide expertise for characterizing pharmacokinetic profiles, dose selection justification, and assessing drug interactions.
  • Author, review, and finalize relevant sections of regulatory filings and respond to health authority questions.

Matching Summary

Match Score: 75

** BeOne Medicines Ltd is seeking a Director of Clinical Pharmacology & Pharmacometrics, responsible for developing strategies for clinical pharmacology and pharmacometrics for oncology drug candidates. The role emphasizes collaboration across various functions and strong regulatory knowledge, with a focus on innovative techniques in drug development. **

Salary

$174,000.00 - $234,000.00 annually; Annual bonus plan and discretionary equity awards; Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • Clinical pharmacology and pharmacometrics strategies
  • Characterize pharmacokinetic profiles
  • Dose selection justification
  • Drug/food interaction assessment
  • QT prolongation assessment
  • Quantitative techniques implementation
  • PK/PD data analysis and interpretation
  • Regulatory filing authoring and defense
  • Global regulatory practices knowledge
  • Phoenix WinNonlin hands-on experience

Nice-to-have

  • Oncology drug development experience
  • Quantitative System Pharmacology (QSP) modeling
  • Bispecific antibody experience
  • AI ML in drug development
  • PBPK modeling experience
  • DMPK studies familiarity
  • Bioanalytical methods familiarity

Key Requirements

  • Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline
  • At least eight years of industry and/or related post-doctoral experience
  • Demonstrable scientific, clinical development and regulatory experience
  • Experience with NDA/BLA/MAA filings and/or publications

Work Rights

Not specified

Tailored Resume

Cover Letter