
Translational Biology Expert
Weekday (YC W21)
contract
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $110 - $135 per hour
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
in vivo studiesin vitro studiesbiomarker strategiesdose escalation strategiespopulation PK/PD modelsstatistical analysis plansexposure-response analysislongitudinal modelingadaptive trial designssafety monitoring
Soft Skills
independent evaluationactionable recommendationscommunication skills
Certifications
PhDMDPharmD