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Overview of the role:

Nucleome Therapeutics is entering a pivotal phase of pipeline expansion, translating its proprietary understanding of 3D gene regulation in disease into a growing portfolio of therapeutic programmes. To support this next stage of growth towards becoming a clinical-stage company, Nucleome Therapeutics is seeking a Principal Scientist, Translational Bioanalysis and Biomarkers, to lead the implementation of integrated bioanalytical and biomarker strategies that will advance Nucleome’s lead molecule, NTP464, through IND/CTA application and into Phase 1 clinical trials.

• Reporting to the Director, Drug Discovery, the Principal Scientist, Translational Biomarkers and Biomarkers will lead biomarker strategy for our lead autoimmune antibody programme during preclinical development. The role will establish fit-for-purpose pharmacokinetic, anti-drug antibody, pharmacodynamic, target engagement and exploratory biomarker plans to support discovery, IND-enabling studies, translational hypotheses, dose selection and proof-of-mechanism. As the programme progresses, the role will support readiness for first-in-human studies, including planning and set-up of translational CRO laboratories for future clinical sample analysis.

Key responsibilities:

• Develop and implement integrated translational biomarker strategies for discovery, preclinical and IND/CTA-enabling studies, including PK, ADA, PD, target engagement and exploratory biomarkers under GxP and fit-for-purpose conditions.
• Partner with nonclinical pharmacology, toxicology, DMPK, bioanalytical and clinical pharmacology colleagues to incorporate biomarkers into preclinical studies and support translational dose selection and programme decision-making.
• Select, manage and oversee CROs, specialty laboratories and bioanalytical vendors, including assay qualification, method transfer, sample logistics, data quality, budgets and timelines.
• Perform laboratory work to support assay development and transfer to CROs.
• Translate findings from research/discovery assays to fit-for-purpose bioanalytical and/or biomarker assays to support preclinical development.
• Prepare for future clinical biomarker implementation, including sample handling requirements, translational CRO laboratory set-up and biomarker contributions to IND-enabling and future clinical documentation.
• Advise other members of the team on assay development requirements.
• Serve as the biomarker representative on programme teams and communicate biomarker strategy, data interpretation and recommendations to internal stakeholders and external partners.

Required Qualifications and Skills:

• PhD or equivalent experience in immunology, pharmacology, biology or a related discipline, with substantial biotech or pharmaceutical experience in preclinical translational science.
• Experience developing translational, PK, ADA, PD and exploratory biomarker strategies for biologics in discovery, preclinical and IND-enabling settings.
• Strong understanding of bioanalytical assay development, qualification and validation, with experience in relevant techniques such as ligand-binding assays, flow cytometry, multiplex assays, transcriptomics, immunohistochemistry, soluble biomarkers and LC/MS, and across laboratory platforms including MSD, Luminex, and/or Ella.
• Experience managing CROs, bioanalytical vendors or specialist laboratories, with knowledge of assay quality, sample logistics and regulatory expectations for biomarker and bioanalytical data.
• Experience in autoimmune or inflammatory disease biology is desirable, together with strong communication, collaboration and hands-on problem-solving skills.
• Strategic, collaborative and hands-on working style, with the ability to operate effectively in a fast-paced biotech environment and influence across functions without direct authority.