Principal Scientist, Translational Clinical Biomarkers

We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within the Neuroscience portfolio. This role will lead the design, execution, analysis, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development.

The successful candidate will develop decision-centric biomarker strategies that integrate therapeutic mechanism, disease biology, pharmacodynamics, patient heterogeneity, dose and regimen selection, clinical endpoints, and opportunities for precision medicine. Biomarker plans will focus on generating high-value, interpretable evidence that informs program decisions and drive clinical development.

• →Develop and lead integrated biomarker strategies across Neuroscience 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.
• →Develop biomarker strategies to address areas such as target engagement, pathway modulation, disease biology, pharmacodynamic response, and patient stratification, utilizing modalities such as fluid sampling, imaging, or digital, as appropriate.
• →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.
• →Drive publications, scientific presentations, external collaborations, and interactions with key external experts as appropriate.

Ph.D., M.D., or equivalent advanced scientific degree with 10+ years of relevant experience in neuroscience, translational medicine, neurobiology, biomarker science, drug development, or a related discipline.

• Significant experience developing and executing translational or clinical biomarker strategies in drug development.
• Scientific expertise relevant to one or more areas within neuroscience, neurodegeneration, neurological disorders, psychiatry, or related disciplines.
• Demonstrated ability to translate scientific hypotheses into biomarker strategies that inform clinical development decisions.
• Strong understanding of the relationship between mechanism of action, disease biology, pharmacology, biomarkers, clinical endpoints, and development strategy.
• Ability to lead cross-functional scientific work in a matrixed environment and influence without direct authority.
• Strong analytical and problem-solving skills, including the ability to synthesize complex datasets into clear, decision-oriented conclusions.
• Ability to prioritize high-value, decision-enabling biomarker work and distinguish it from lower-priority exploratory activities.
• Excellent written and verbal communication skills and the ability to communicate scientific strategy to stakeholders.
• Working knowledge of biostatistics, bioinformatics, quantitative sciences, and multidimensional biomarker data analysis.
• Strategic mindset with a focus on scientific rigor, prioritization, scalability, and generation of actionable evidence.

• Experience supporting programs across multiple stages of clinical development.
• Experience with pharmacodynamic, predictive, prognostic, patient-stratification, or precision-medicine biomarker strategies.
• Experience in neuroscience drug development (e.g. neurodegenerative diseases like Alzheimer’s or Parkinson’s).
• Experience working across multiple programs or therapeutic areas.
• Experience mentoring or providing scientific direction to other scientists.

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Biomarkers, Clinical Development, Clinical Research, Clinical Study Design, Data Translation, Ethical Compliance, Ethical Standards, Mechanism of Action, Neurodegenerative Diseases, Neurological Disorders, Neuroscience, Patient Care, Personalized Medicine, Pharmacodynamics, Scientific Presentations, Scientific Writing, Strategic Thinking, Translational Medicine.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.