Senior Director, Clinical Pharmacology and Pharmacometrics

7 days ago


California, United States Recruits Lab (We're hiring) Full time
About the Role

We are seeking a highly experienced and skilled Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join our team at Recruits Lab. As a key member of our organization, you will play a pivotal role in shaping the future of oncology medicine.

Key Responsibilities
  • Lead Clinical Pharmacology Programs: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development.
  • Author Regulatory Documents: Author clinical protocols, study reports, and data analyses (exposure/efficacy/safety) to support the development and registration of new products.
  • Apply Pharmacometrics Methodologies: Apply state-of-the-art pharmacometrics methodologies, including population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling, exposure-response analyses, and physiological-based pharmacokinetic modeling.
  • Ensure Regulatory Compliance: Write, review, and edit relevant sections of regulatory documents (INDs, NDAs, IBs) and respond to regulatory inquiries.
  • Manage Clinical Studies: Ensure adherence to timelines and budgets for clinical pharmacology studies and programs.
  • Communicate Scientific Findings: Lead the writing of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
  • Collaborate with External Partners: Engage and manage CROs to support pharmacometrics analyses and ensure compliance with agreed protocols, quality standards, and timelines.
Requirements
  • A Ph.D. or PharmD with a minimum of 10 years of industry experience in pharmaceutical sciences, pharmacokinetics, clinical pharmacology, chemistry, or related fields.
  • Extensive experience in pharmacometrics analysis, including study design, data analysis, and modeling simulation.
  • Proficiency in modeling software packages such as Phoenix WinNonlin, NONMEM, R, SAS, or similar tools.
  • Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements.
  • Experience in managing external resources, including CROs and consultants.
  • Excellent interpersonal, organizational, and teamwork skills are required to communicate effectively with external collaborators and internal project teams.
  • Ability to thrive in a fast-paced, dynamic environment while maintaining a positive attitude and superior work ethic.
What We Offer
  • Competitive salary range: $223,449 - $337,470 per year (Director level) | $273,771 - $337,470 per year (Senior Director level).
  • Comprehensive benefits package, including medical/dental/vision coverage, retirement benefits, ESPP, and wellness programs.
  • Annual bonus and equity refresh for full-time employees.
  • An inclusive and collaborative work environment where your ideas are valued and your voice is heard.


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