Remote | Clinical Pharmacologist; PK​/PD & Dose Strategy

Specialised Part-Time Consulting Opportunity for Experienced Clinical Pharmacologists

We are sharing a specialised part-time consulting opportunity for experienced clinical pharmacologists with substantial expertise in pre-market drug development, PK/PD analysis, dose selection, exposure-response modelling, and clinical pharmacology strategy.

This role supports advanced clinical research workflows involving the generation and validation of pharmacology data across Phase I–III programmes. Selected experts will help develop clinically plausible PK/PD datasets, dosing and escalation regimens, exposure-response relationships, and pharmacology-focused reference materials that remain consistent with efficacy and safety outputs.

Clinical Pharmacology Data Generation

• Develop and validate synthetic clinical pharmacology datasets
• Create realistic PK and PD data aligned with study protocols and development objectives
• Ensure dosing, concentration, efficacy, and safety information reconcile across the broader clinical data package
• Review generated pharmacology outputs for clinical plausibility and internal consistency
• Identify unrealistic exposure patterns, dosing assumptions, or pharmacodynamic relationships

PK/PD Analysis

• Apply hands-on expertise in pharmacokinetics and pharmacodynamics
• Evaluate concentration-time profiles, exposure metrics, and pharmacodynamic responses
• Review relationships between dose, exposure, response, and safety
• Assess whether proposed PK/PD interpretations are supported by the underlying data
• Identify inconsistencies or unsupported conclusions in pharmacology analyses

Dose Selection & Escalation

• Develop and review dose-selection rationales for clinical programmes
• Evaluate dose-escalation strategies and supporting evidence
• Assess starting-dose, escalation, expansion, and recommended-dose decisions where relevant
• Integrate PK, PD, efficacy, and safety information into dose rationale
• Apply practical judgement from pre-market clinical development

Exposure-Response Analysis

• Develop and assess exposure-response relationships across efficacy and safety endpoints
• Evaluate whether modelled relationships are biologically and clinically credible
• Review assumptions, covariates, and interpretation of concentration-response findings
• Identify overextended or unsupported conclusions
• Translate quantitative findings into clear clinical-development recommendations

Drug Interaction Assessment

• Develop and review content involving drug-drug interactions
• Evaluate pharmacokinetic and pharmacodynamic interaction risks
• Assess drug-disease interactions and clinically relevant population effects
• Review implications for dosing, monitoring, and study design
• Ensure recommendations are appropriately supported by available evidence

Bioanalytical & Concentration Data

• Review bioanalytical reports and concentration datasets for consistency
• Assess whether assay outputs and concentration data support downstream PK analysis
• Identify implausible values, missing relationships, or reconciliation issues
• Evaluate how bioanalytical limitations affect pharmacology conclusions
• Ensure concentration data remain traceable across related analyses and outputs

Clinical Pharmacology Task Development

• Design realistic clinical pharmacology assignments based on Phase I–III workflows
• Develop tasks involving dose rationale, PK/PD interpretation, exposure-response, and interaction assessment
• Produce authoritative reference outputs for complex pharmacology scenarios
• Define objective criteria for evaluating technical accuracy, completeness, and clinical reasoning
• Create tasks that reflect how experienced clinical pharmacologists work in practice

Ideal Profile

• 5+ years of professional clinical pharmacology experience, with 10–25 years preferred
• Demonstrated experience supporting pre-market Phase I–III clinical programmes
• Strong hands-on expertise in PK/PD analysis
• Direct experience with dose selection and dose-escalation strategy
• Strong experience with exposure-response analysis
• Comfortable working from clinical protocols and Statistical Analysis Plans
• Experience developing pharmacology outputs that integrate with efficacy and safety datasets
• First-in-human clinical…