Director, Clinical Pharmacology

Mirum Pharmaceuticals

Foster City, California, United States
**
12-15 years clinical pharmacology experience
Design and execution of clinical studies
Authoring regulatory documents ind nda maa
** Mirum Pharmaceuticals is seeking a Director of Clinical Pharmacology to lead clinical pharmacology strategies for rare disease assets. The ideal candidate will have extensive experience in clinical pharmacology and a strong background in regulatory processes, particularly in the context of rare diseases. **

Job Summary

  • The Director of Clinical Pharmacology will lead the strategy and execution of clinical development programs for rare disease assets.
  • This role requires authoring critical regulatory documents including Investigator's Brochures, NDAs, and briefing materials.
  • Mirum Pharmaceuticals seeks a collaborative professional who embodies values of care, being real, getting it done, and having fun.

Matching Summary

Match Score: 75

** Mirum Pharmaceuticals is seeking a Director of Clinical Pharmacology to lead clinical pharmacology strategies for rare disease assets. The ideal candidate will have extensive experience in clinical pharmacology and a strong background in regulatory processes, particularly in the context of rare diseases. **

Skills & Requirements

Must-have

  • 12-15 years clinical pharmacology experience
  • Design and execution of clinical studies
  • Authoring regulatory documents IND NDA MAA
  • Managing collaborations with CROs

Nice-to-have

  • Experience with liver or neurology indications
  • Knowledge of PopPK PBPK modeling
  • Experience with antibody ADC modalities
  • Self-directed and detail-oriented approach

Key Requirements

  • BS in Biological Sciences with 12-15+ years experience
  • Advanced degree (PhD PharmD) with 10+ years experience
  • Solid knowledge of GCP compliance

Work Rights

Not specified

Tailored Resume

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