Responsibilities:
- Lead clinical pharmacology strategy, dose selection, and PK/PD and biomarker planning across early and late-stage programs.
- Conduct and interpret PK, PK/PD, exposureβresponse, and simulation analyses using NONMEM, WinNonlin, R, Python, and Simcyp.
- Integrate translational and nonclinical PK/PD data to support FIH dose projections and DDI assessments.
- Oversee bioanalytical CROs to ensure high-quality PK/PD/biomarker data and GLP/GCP compliance.
- Partner with Clinical Operations on sample management and protocol design.
- Communicate quantitative findings and contribute to regulatory documents (protocols, IBs, INDs, NDAs, IMPDs).
- Collaborate across Clinical Development, Biostats/Data Science, Nonclinical, and Program Management.
Key Requirements and Qualifications:
- PhD, PharmD, or equivalent in Pharmacokinetics, Pharmacology, or related field.
- 6β8+ years of industry experience in Clinical Pharmacology, DMPK, or Quantitative Pharmacology.
- Strong expertise in PK, PK/PD, DMPK, and translational sciences.
- Proficiency with NONMEM, WinNonlin, Simcyp, R, and Python.
- Excellent communication, organization, and ability to work independently in a fast-paced environment.
Benefits (explicitly stated):
- Salary range: $200,000β$240,000 USD annually; annual bonus program; stock option grants.
- Health insurance premiums paid at 90% for employee, 80% for dependents; $100 monthly cell phone stipend; unlimited PTO (exempt); free onsite gym and snacks/drinks.