• Develop and lead integrated biomarker strategies across CVM and ID/Vaccines programs, in partnership with cross-functional development teams.
• Translate disease biology and therapeutic mechanism into clear translational hypotheses and fit-for-purpose biomarker approaches.
• Define how biomarkers can inform key development questions including proof of biology, target engagement, dose and regimen selection, patient stratification, response assessment, and go/no-go decisions.
• Ensure biomarker strategies are focused and scalable, with clear linkage between the development question, proposed measurement, expected result, and potential action.
• Serve as the biomarker representative on cross-functional program teams and provide strategic biomarker input to program-level decision making.
• Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, and other functions to develop integrated translational strategies.
• Lead the interpretation of biomarker and clinical datasets and translate complex findings into clear, actionable recommendations.
• Identify opportunities to understand disease heterogeneity, therapeutic response, resistance or non-response, and biological drivers of clinical outcomes.
• For infectious diseases and vaccines, develop biomarker strategies addressing areas such as host and pathogen biology, immune response, correlates of protection, pharmacodynamic response, and patient or population stratification, as appropriate.
• For cardiovascular and metabolic programs, develop biomarker strategies addressing areas such as target engagement, pathway modulation, disease biology, pharmacodynamic response, patient heterogeneity, and relationships between biological effects and clinical outcomes.
• Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions.
• Communicate biomarker strategies, results, risks, and recommendations clearly to cross-functional teams and key stakeholders.
• Provide scientific guidance and mentorship to biomarker scientists and contribute to a collaborative, strategically focused biomarker organization.
• Support publications, scientific presentations, external collaborations, and interactions with key external experts as appropriate.