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.