Strategic Translational Biomarkers Lead

Merck

Boston (MA)

Hybrid

USD 191,000 - 300,000

Full time

3 days ago

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Job summary

Merck seeks a Principal Scientist to lead biomarker strategies across Cardiovascular & Metabolic and Infectious Diseases/Vaccines programs. You will translate biology into translational hypotheses, guide target engagement and dose decisions, and partner with Discovery, Regulatory, Data Science, and Clinical Operations to shape translational plans.

Ideal candidates have a Ph.D./M.D. and a proven track record in translational biomarker science applied to drug or vaccine development, with strong

Qualifications

Significant experience developing and executing translational or clinical biomarker strategies in drug or vaccine development.
Scientific expertise relevant to cardiovascular, metabolic, infectious diseases or vaccines.
Ability to translate hypotheses into biomarker strategies informing development decisions.
Strong cross-functional leadership in a matrixed environment.

Responsibilities

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 host and pathogen biology, immune response, correlates of protection, pharmacodynamic response, and population stratification.
For cardiovascular and metabolic programs, develop biomarker strategies addressing 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.