Clinical Pharmacologist – PK/PD, Dose Strategy

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Develop and validate synthetic datasets for clinical pharmacology.

• Generate realistic pharmacokinetic (PK) and pharmacodynamic (PD) data that are aligned with study protocols and development goals.

• Reconcile dosing, concentration, efficacy, and safety information throughout the comprehensive clinical data package.

• Review pharmacology outputs for clinical plausibility and internal consistency.

• Evaluate concentration-time profiles, exposure metrics, and pharmacodynamic responses.

• Assess relationships between dose, exposure, response, and safety.

• Develop and review rationales for dose selection and strategies for dose escalation.

• Evaluate decisions regarding starting doses, escalation, expansion, and recommended doses.

• Integrate PK, PD, efficacy, and safety information into rationales for dosing.

• Develop and assess exposure-response relationships across both efficacy and safety endpoints.

• Review assumptions, covariates, and findings related to concentration-response.

• Translate quantitative findings into recommendations for clinical development.

• Develop and review content related to drug-drug and drug-disease interactions.

• Review bioanalytical reports and concentration datasets.

• Design clinical pharmacology assignments based on workflows from Phase I to III.

• Produce authoritative reference outputs and define evaluation criteria for complex pharmacology scenarios.

⛳️ Requirements

• Over 5 years of professional experience in clinical pharmacology; 10 to 25 years preferred.

• Proven experience in supporting pre-market Phase I to III clinical programs.

• Strong practical expertise in PK/PD analysis.

• Direct experience in dose selection and strategies for dose escalation.

• Extensive experience with exposure-response analysis.

• Comfortable working from clinical protocols and Statistical Analysis Plans.

• Experience developing pharmacology outputs that integrate with datasets of efficacy and safety.

• First-in-human clinical development experience is strongly preferred.

• PharmD, PhD in Pharmacology, Pharmacokinetics, or a related field, MD, or an equivalent advanced qualification.

• Strong quantitative skills and clinical judgment.

• Excellent written communication skills with the ability to convey complex pharmacology conclusions clearly.

• Must be based in the United States, Canada, or France.

• Minimum availability of approximately 20 to 25 hours per week.

• Work must be carried out without using any confidential or proprietary information belonging to employers, sponsors, clients, institutions, or other third parties.

• H1-B and STEM OPT support is not available for this engagement.

🏝️ Benefits

• Engagement as a part-time independent contractor.

• Fully remote work environment.

• Flexible scheduling according to project requirements.

• Projects may be extended, shortened, or concluded based on project needs and performance.