Associate Director, Clinical Pharmacology, Modeling & Simulation

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Job Title: Associate Director, Clinical Pharmacology, Modeling & Simulation
Department: R&D: Clinical
Reports To: Vice President of Clinical Pharmacology
FLSA Status: Exempt
Location: San Diego or Remote
Travel:  up to 10%

Summary

The Associate Director, Clinical Pharmacology (CP), Modeling & Simulation (M&S) will be a key member of the Clinical Pharmacology group and will report directly to the VP of Clinical Pharmacology. This individual will apply strong pharmacometrics skills to independently determine, plan, and execute modeling and simulation analyses.

Responsibilities

  • Serve as a core member of cross-functional drug development teams
  • Serve as the M&S lead for pharmacometrics deliverables, including population PK, PK-PD, exposure-response, model-based meta-analysis, trial simulation, etc.
  • Participate in preparation of regulatory responses and submissions, interactions with health authorities as pharmacometrics subject matter expert (SME)
  • Collaborate with internal and external SMEs to develop and enhance pharmacometrics methodologies and capabilities
  • Be responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies.

Qualifications

  • 6+ years of Pharmaceutical or Biotech experience
  • Experience with development of small molecules is a must; experience with pediatric development is a plus
  • PhD degree in life sciences (e.g., biology, biochemistry, biophysics, or pharmacology), chemical engineering, pharmacokinetics, or related disciplines with 6+ years relevant experience in PK/PD, systems pharmacology, and mathematical modeling
  • Expertise with modeling software including NONMEM, R etc.  Experience with PBPK modeling is a plus
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
  • Excellent verbal, presentation, and written communication skills
  • Demonstrated understanding of CMC, translational biomarkers, drug metabolism & transporters, pharmacokinetics, and drug development
  • Ability to foster relationships within an organization and advance the concepts of model informed drug development (MIDD)
  • Record of publications, presentations, and volunteering for professional organizations