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

Strong candidates may have:
PhD, MD, and/or PharmD 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 Kingdom

Preferred qualifications

Breadth across multiple translational and clinical development domains
Experience working across both preclinical and early clinical decision-making workflows
Familiarity with biomarker strategy, exposure-response modelling, and adaptive study design
Experience contributing to cross-functional drug development teams
Strong scientific judgment in situations involving ambiguity, evolving data, and portfolio trade-offs

Why This Opportunity

Contribute to high-impact work spanning translational biology, early development, and clinical decision-making
Apply advanced scientific expertise to complex therapeutic programs and strategic inflection points
Work on intellectually rigorous projects involving preclinical, clinical, and quantitative development challenges
Flexible remote work with competitive compensation

Contract Details

Independent contractor role
Fully remote with flexible scheduling
Compensation range of $110–$135 per hour
Weekly payments via Stripe or Wise
Projects may be extended, shortened, or concluded early depending on project needs and performance
Work will not involve access to confidential or proprietary information from any employer, client, or institution
Please note: We are unable to support H1-B or STEM OPT candidates at this time
Candidates should be based in the United States or United Kingdom

About the Platform

This opportunity is available through a leading AI-driven work platform that connects domain experts with frontier AI research projects.

Experts contribute to improving advanced AI systems by providing specialised expertise across scientific reasoning, translational biology, preclinical and clinical development strategy, and domain-specific evaluation.

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