Immunomeinc

Senior Director, Pharmacometrics

Bothell, Washington, United States. Posted 4 months ago

The role

The Senior Director, Pharmacometrics will lead model-informed drug development strategies across a targeted oncology portfolio. This role involves designing and executing pharmacometric analyses to support clinical development decisions, dose optimization, and regulatory submissions.

What you will do

  • Develop and implement pharmacometrics strategies across clinical development programs.
  • Serve as the pharmacometrics strategy lead for assigned programs.
  • Lead the development and execution of population PK, PK/PD, exposure-response, and model-based meta-analysis strategies.
  • Apply PBPK, QSP, translational modeling, or simulation approaches.
  • Oversee analysis plans, model development, simulations, and quality control.
  • Partner with cross-functional teams to integrate pharmacometrics deliverables into development plans.
  • Provide input into clinical protocols and sampling strategies.
  • Author and review pharmacometrics components for regulatory submissions like IND, NDA, and BLA.
  • Identify, qualify, and manage external pharmacometrics vendors and CRO partners.
  • Lead and mentor pharmacometricians and quantitative scientists.

Required qualifications

  • Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmaceutical Sciences, Statistics, Bioengineering, Applied Mathematics, or related quantitative discipline with 12+ years of relevant experience in t
  • M.S. with 15+ years of relevant experience
  • B.S. with 18+ years of relevant experience
  • Demonstrated track record leading pharmacometrics strategy and execution across multiple clinical-stage programs
  • Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development
  • Experience supporting global regulatory filings and interactions
  • Hands-on experience with pharmacometrics and quantitative analysis tools such as NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus, or related platforms
  • Experience managing external pharmacometrics vendors, CROs, and consultants
  • Oncology drug development experience required

Nice to have

  • experience with ADCs, biologics, targeted radiotherapies, or small molecules

Benefits

  • Medical, dental, and vision insurance coverage for employees and dependents
  • 100% company-paid medical premiums for employees
  • 401(k) with employer match
  • Employer-paid life insurance, short- and long-term disability insurance, and AD&D
  • Paid time off
  • Company holidays
  • A week-long winter break between Christmas and New Years
  • Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.

Senior Director, Pharmacometrics at Immunomeinc | JobZoey