Translational Biology Expert

This role is for one of our clients Compensation: $110-$135 per hour We are seeking PhD-level Translational Biology Experts with deep expertise spanning preclinical research through early clinical development . This role is ideal for professionals who have contributed to or led programs progressing from target validation to first-in-human studies , and can independently drive strategic decisions at critical development milestones.

You will support high-impact initiatives including preclinical strategy, data interpretation, clinical program design, and quantitative analysis , helping guide data-driven decisions across the drug development lifecycle.

Requirements Key Responsibilities Preclinical Study Design & Execution

• 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.

Preclinical Data Interpretation & Decision-Making

• 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.

Early Clinical Program Design

• 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.

Quantitative Pharmacology & Clinical Modeling

• 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.
• Conduct sensitivity analyses addressing missing data and protocol deviations.

Clinical Biostatistics

• 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.

Ideal Candidate Profile

• 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.

Contract & Engagement Details

• Engagement on an independent contractor basis.
• Fully remote with flexible working hours.
• Project duration may vary based on performance and business needs.
• Work involves only non-confidential, publicly available information.
• Payments processed weekly via Stripe or Wise based on completed work.
• Candidates requiring H1-B or STEM OPT sponsorship are not eligible.

Core Skills Translational Biology | Preclinical Research | Clinical Development | PK/PD Modeling | Biostatistics