Job Description
ROLE SUMMARY: The Clinical and Translational Biomarker (CTB) Lead will be responsible for developing translational biomarker strategies for assigned assets with a focus on weight management related comorbidities and cardiometabolic disease within the PRD portfolio from LD thought FIH to registration and post marketing activities. The lead is also accountable and responsible for implementation of this strategy through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant biomarker analytical assays and data. They contribute to biomarker sections of the clinical development plans, clinical protocols, internally and externally facing presentations and manuscripts, regulatory filings, label claims and registration paths. ROLE RESPONSIBILITIES: Utilize understanding of disease biology and therapeutic mechanism of action in collaboration with team to develop and deliver clinical biomarker strategies and assays. Deliver biomarker data and insight to support program decisions for key milestones (eg POM/SOCA etc), label claims, commercial differentiation and targeted reverse translation. Assembles and lead collaborative biomarker sub-teams to develop, refine, and operationalize biomarker strategy. Serves as a member of the clinical study team and as a biomarker subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review, clinical development plans, preparing submissions, addressing regulatory queries, developing commercial differentiation strategies, implementing biomarker bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines. Leads and oversees fit-for-purpose biomarker assay lifecycle management including bioanalytical development and method design, validation, data quality review, sample analyses & reporting to meet evolving program objectives and regulatory expectations. Functions as key point of contact with external & internal laboratories and leads selection, qualification, performance evaluation, periodic visits and audits of CRO laboratories conducting clinical biomarker assays. Assists CROs with effective troubleshooting of biomarkers assays and issue resolution. Contributes to and reviews clinical protocols, clinical development plans, bioanalytical plans and report documents, biomarker statistical analysis plans, budgeting and invoicing, health agency submissions, lab manuals, CRF and data transfer specifications, commercial differentiation strategies and informed consent language document sections specific to biomarkers in compliance with clinical SOPs & policies, and regulatory guidance. May participate in above asset initiatives such as phase 0 natural history and methodology studies to help expand and sustain the portfolio pipeline. May support due diligence activities as Biomarker SME. May consult on CRC studies and research initiatives managed by Medical Affairs. Works with Clinical Pharmacology, Pharmacometrics & Systems Pharmacology Biomarker Statistics and Clinical to interpret biomarker results in the context of clinical studies. Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications. Maintains up-to-date knowledge of assay technologies, clinical laboratory standards, global regulatory guidance & expectations, and industry best practices. Contributes to the development of Best Practices processes, templates, and policies. ORGANIZATIONAL RELATIONSHIPS: Reports to the Head of Clinical and Translational Biomarkers. Provides matrix Clinical Biomarker sub team leadership with research, technical, and clinical colleagues. Collaborates closely with project team members, particularly with R&D Therapeutic Area Scientists and Clinical Leads, Clinical Pharmacology, Pharmacometrics & Systems Pharmacology, Clinical & Bioanalytical Statistics, PCRUs and Medical Team Leads. Other important partnerships include Clinical Bioanalytics, Clinical Operations, Data Management, Pharmacokinetics, Dynamics and Metabolism (PDM), Medical Affairs, Drug Safety, Regulatory, RWE, Quality and Procurement. BASIC QUALIFICATIONS: PhD or equivalent in biology, immunology, biochemistry, molecular biology, clinical laboratory sciences, analytical chemistry/chemistry or related field and 1+ year(s) of relevant experience; MS degree and 5+ years of relevant experience OR BS degree and 6+ years of relevant experience. Experience in biomarker discovery and/or development and implementation of biomarkers plans in clinical