Associate Director, Clinical Pharmacology, Pharmacometrics

This is a fully remote position, open to applicants in United States.

📋 Description

• Acts as the representative for clinical pharmacology and pharmacometrics within cross-functional project teams.

• Chooses and applies suitable modeling and simulation techniques (PK/PD, PopPK, exposure-response) to guide dose selection, optimization, and justification.

• Collaborates closely with biometrics to prepare analysis-ready datasets.

• Assists in developing tailored clinical pharmacology strategies to support development and regulatory decisions from pre-IND to market authorization.

• Works in partnership with cross-functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory to facilitate program progress.

• Aids in the design and execution of Phase 1 clinical pharmacology studies (e.g., FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc.).

• Authors and provides technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs.

⛳️ Requirements

• PhD or PharmD or equivalent, with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or a related field.

• Over 6 years of industry experience in Clinical Pharmacology and/or Pharmacometrics.

• Capable of conveying complex data and concepts to a variety of audiences.

• Knowledge of the multidisciplinary needs for drug development and the ability to work effectively across functions to drive program advancement.

• Experience with PK/PD, PopPK, and exposure-response modeling, with proficiency in R and extensive hands-on experience with Monolix or NONMEM required.

• Background in translational and clinical pharmacology work from FIH dose selection to market authorization.

• Experience in contributing to clinical pharmacology plans and the clinical pharmacology aspects of regulatory submissions, as well as representing clinical pharmacology in regulatory discussions.

• Extensive familiarity with biologics, including monoclonal antibodies and bispecifics.

• Preferred experience with clinical pharmacology and/or pharmacometrics strategy for oncology and/or immunology indications, along with knowledge of clinical pharmacology strategies for immune-modulating agents.

• Proficient in using standard PK analysis and graphing software (Phoenix WNL, Graphpad, R, etc.).

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Paid time off.

• Opportunities for professional development.