Director of Clinical Pharmacology and Pharmacometric
Benefits:
401(k)
Bonus based on performance
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Vision insurance
Position Summary:
The Director will apply advanced pharmacometric approaches to support drug development from late preclinical development through registration. This role is responsible for conducting population PK, PK/PD, and exposure–response analyses, contributing to model-based drug development (MBDD), and preparing high-quality regulatory documentation.
The ideal candidate is a hands-on modeler who can organize and model nonclinical and clinical PK, PD, efficacy and safety data. The Director will interact directly with clients and will provide quantitative input into study designs and dose selection, and ensure deliverables meet regulatory and client expectations.
Key Responsibilities:
Modeling & Analysis:
Lead population PK, PK/PD, and exposure–response/safety modeling using NONMEM, Monolix, R, or equivalent tools.
Develop, validate, and execute modeling and simulation plans for clinical development.
Conduct noncompartmental PK analyses (NCA)
Contribute to nonclinical, clinical pharmacology, and pharmacometric sections of protocols, study reports, IBs, and regulatory submissions (IND, NDA, BLA, briefing documents).
Provide quantitative justifications for dose/regimen selection and study designs in alignment with regulatory expectations.
Work with clients and bioanalytical scientists to deliver integrated CP outputs.
Present results and recommendations to internal teams, clients, and (as appropriate) regulatory agencies
Mentor junior pharmacometricians and data analysts in NCA, modeling, and regulatory writing.
Contribute to building internal best practices and SOPs in quantitative pharmacology.
Qualifications & Educational Requirements:
Ph.D. (preferred) or Pharm.D./M.D. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacology, or related field.
5+ years of quantitative pharmacology and pharmacometrics experience in a CRO, pharmaceutical, or biotech environment.
Demonstrated expertise in PopPK, PK/PD modeling & simulation, exposure–response analysis, and MBDD.
Proficiency with quantitative tools: NONMEM, Monolix, Phoenix WinNonlin/NLME, R, SAS.
Understanding of regulatory expectations (ICH, FDA, EMA) for nonclinical, clinical pharmacology and pharmacometric analyses.
Familiarity with regulatory requirements and expectations for quantitative analyses.
Strong data interpretation, problem-solving, and scientific writing skills.
Effective communicator, able to collaborate in cross-functional and client-facing settings.
This is a remote position.