Translational Biology Expert

Role Overview

• Design and execute in vivo and in vitro studies linking molecular mechanisms to disease-relevant outcomes.
• Select appropriate preclinical models with strong rationale for human translatability.
• Develop biomarker strategies spanning target engagement to clinical response.
• Evaluate formulation and delivery strategies for optimal tissue targeting.
• Troubleshoot inconclusive or negative results and recommend next steps.
• Build exposure-response relationships to inform clinical predictions.
• Assess whether preclinical evidence supports target engagement and therapeutic activity.
• Refine mechanistic hypotheses and design follow-up experiments.
• Evaluate early safety signals and investigate biological drivers.
• Assess immunogenicity risks and downstream implications.
• Support portfolio decisions such as advancement, pivot, or termination based on data quality and risk.
• Define safe and pharmacologically relevant starting doses for first-in-human studies.
• Design dose escalation strategies informed by pharmacodynamics and safety margins.
• Determine appropriate study power based on variability and expected outcomes.
• Define patient selection and biomarker-driven enrichment strategies.
• Select meaningful endpoints, balancing surrogate and clinical measures.
• Plan interim analyses, safety monitoring, and adaptive trial designs.
• Conduct exposure-response analysis and dose optimization.
• Develop population PK/PD models and assess covariate impacts.
• Support dose decisions using real-time trial data.
• Perform longitudinal modeling of treatment response and efficacy trends.
• Design statistical analysis plans across varied endpoint types (binary, continuous, time-to-event).
• Implement multiplicity adjustments and sample size calculations.
• Conduct subgroup and heterogeneous treatment effect analyses.
• Address estimand considerations, missing data, and dropout handling.
• Design adaptive trials with interim monitoring, futility criteria, and alpha control.

Requirements

• PhD, MD, or PharmD in Pharmacology, Pharmaceutical Sciences, Biostatistics, Quantitative Biology, or related fields.
• 5+ years of industry experience in pharma, biotech, or CRO environments.
• Direct experience supporting programs from late preclinical stages through IND or early clinical development.
• Strong ability to independently evaluate complex datasets and provide clear, actionable recommendations.
• Excellent communication skills for both technical and non-technical stakeholders.
• Based in the United States or United Kingdom.