Remote | Translational Biology Expert

Position: Remote | Translational Biology Expert — Up to $135/hr We are sharing a specialised part‑time consulting opportunity for PhD‑level life sciences experts with deep experience spanning late preclinical development through early clinical stages. This role supports high‑impact scientific and strategic work across translational biology, preclinical development, early clinical program design, and quantitative decision‑making for therapeutic programs. Selected professionals will help evaluate complex data packages, support preclinical and early clinical strategy, interpret biological and pharmacological findings, and contribute clear, actionable recommendations across critical development inflection points. Key Responsibilities Professionals in this role may contribute to: Preclinical Study Design & Execution • Design and evaluate in‑vivo studies linking molecular mechanism to disease‑relevant phenotypes • Select appropriate preclinical systems, including in‑vitro, ex vivo, and animal models, with strong rationale for human translatability • Develop biomarker strategies spanning target engagement through clinical response, including practical assay and sample collection considerations • Evaluate formulation and delivery approaches for tissue access across different therapeutic modalities • Troubleshoot inconclusive or negative preclinical results and recommend next steps Preclinical Data Interpretation & Decision‑Making • Build exposure‑activity relationships from in‑vivo datasets to inform clinical predictions • Evaluate whether preclinical evidence supports activity at the intended site of action • Update mechanistic hypotheses as new data emerges and design follow‑up experiments to resolve ambiguity • Assess early safety observations and develop hypotheses regarding biological basis • Evaluate immunogenicity risk and potential downstream consequences • Support portfolio‑level decisions such as advance, pivot, or terminate based on data quality and residual uncertainty Early Clinical Program Design • Determine safe and pharmacologically relevant starting doses for human studies, including cross‑species scaling considerations and limitations • Design dose‑escalation schemes informed by expected pharmacodynamic time courses and safety margins • Support powering of early‑phase studies based on biological variability and expected effect sizes • Define patient selection and enrichment strategies using biomarker and epidemiological data • Select appropriate endpoints, including surrogate and clinical endpoints • Plan interim analyses, safety monitoring approaches, and adaptive decision rules Quantitative Pharmacology & Clinical Modeling • Support exposure‑response analysis and model‑informed dose optimisation • Contribute to population PK and PK/PD modelling, including covariate identification and impact assessment • Use accumulating trial data to support dose‑escalation decisions • Support longitudinal efficacy modelling, including time‑to‑effect and trajectory‑based analyses • Conduct sensitivity analyses addressing missing data, protocol deviations, and intercurrent events Clinical Biostatistics • Contribute to statistical analysis planning across binary, continuous, and time‑to‑event endpoints • Support multiplicity‑adjusted hypothesis testing and sample size determination • Evaluate subgroup and heterogeneous treatment effect analyses with appropriate false discovery controls • Address estimand‑related considerations, including missing data frameworks and dropout patterns • Support adaptive and interim monitoring design, including futility boundaries and alpha‑spending functions Ideal Profile • PhD, MD, and/or Pharm D in pharmacology, pharmaceutical sciences, biostatistics, quantitative biology, or a related field • 5+ years of industry experience in pharma, biotech, or CRO environments • Direct experience supporting at least one program from late preclinical stages through IND or into early clinical development • Strong expertise in translational biology, preclinical strategy, clinical design, quantitative pharmacology, or biostatistics • Ability to independently evaluate complex scientific data packages and deliver actionable recommendations • Strong communication skills for both technical and non‑technical audiences • Based in the United States or United…