Location: Princeton, NJHybrid Opportunity
A clinical-stage biopharmaceutical company is seeking a Senior Manager or Associate Director of Clinical Pharmacology to support the development of innovative therapeutics. This individual will play an important role in clinical pharmacology strategy, quantitative analyses, dose optimization, and the application of modeling and simulation to clinical drug development. The position offers the opportunity to work cross-functionally with Clinical Development, Research, Regulatory, Biometrics, and other teams to support development decisions and advance clinical programs.
Key Responsibilities:
Develop and execute clinical pharmacology strategies across clinical development programs.
Support dose selection, dose optimization, dosing schedules, and drug-drug interaction assessments.
Conduct and interpret quantitative pharmacology analyses, including pharmacokinetic, pharmacodynamic, population modeling, and exposure-response analyses.
Apply modeling and simulation to address scientific questions and support clinical development decisions.
Contribute to the design and execution of clinical pharmacology studies, including first-in-human, proof-of-concept, and registrational studies.
Prepare and review clinical pharmacology sections of study protocols, clinical study reports, investigator brochures, and regulatory submissions.
Support responses to regulatory questions and collaborate with cross-functional development teams.
Qualifications:
MS, PharmD, or PhD in Pharmacology, Pharmaceutical Sciences, or a related discipline.
Experience in clinical pharmacology and pharmacometrics, with hands-on involvement in quantitative analyses.
Strong understanding of pharmacokinetics, pharmacodynamics, PK/PD, exposure-response, and clinical drug development.
Practical experience with modeling and simulation approaches, such as noncompartmental analysis, population pharmacokinetics, or exposure-response modeling.
Familiarity with relevant analytical tools, such as NONMEM, R, Phoenix WinNonlin, or Simcyp.
Understanding of clinical pharmacology study design and regulatory requirements.
Experience supporting clinical development decisions and collaborating across scientific functions.
Experience with biologics, oncology, or antibody-drug conjugates is advantageous but not required.
Compensation:
The anticipated base salary range is $150,000–$200,000 annually, depending on relevant experience, qualifications, and skills.
