Principal Scientist, Translational Clinical Biomarkers

Caraway Therapeutics, Inc.; San Francisco (CA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Caraway Therapeutics, Inc. is seeking a Principal Scientist to provide strategic biomarker leadership across Neuroscience programs. You will design, execute, analyze, and communicate translational and clinical biomarker strategies from early to late development.

The role focuses on integrating mechanism, biology, pharmacodynamics, patient heterogeneity, and precision medicine to generate high-value evidence guiding clinical decisions. Hybrid work model in San Francisco region may apply.

Qualifications

• Experience leading translational/clinical biomarker strategies in drug development.
• Expertise in neuroscience or related neurodegenerative disciplines.
• Ability to translate biology and mechanism into biomarker strategies for development decisions.
• Strong understanding of MOA, pharmacodynamics, endpoints, and development strategy.

Responsibilities

• Develop and lead integrated biomarker strategies across Neuroscience programs.
• Translate disease biology into translational hypotheses and biomarker approaches.
• Define biomarker-informed development questions and go/no-go decisions.
• Ensure biomarker plans are focused, scalable, and linked to actions.
• Serve as biomarker representative on cross-functional program teams.
• Collaborate with Discovery, Clinical Development, Regulatory, and Data Science teams.
• Interpret biomarker and clinical data to provide actionable recommendations.
• Identify opportunities to understand disease heterogeneity and patient stratification.
• Develop strategies utilizing fluid sampling, imaging, or digital modalities.
• Evaluate emerging biomarker technologies and analytical approaches.
• Communicate biomarker strategies and results to stakeholders.
• Mentor biomarker scientists and drive publications and collaborations.

Skills

Biomarker strategies

Cross-functional leadership

Translational medicine

Neuroscience

Biostatistics

Bioinformatics

Imaging analysis

Scientific communication

Education

Ph.D., M.D., or equivalent advanced degree

Tools

Biostatistics tools

Bioinformatics

Imaging analysis software

Data visualization

Job description

Job Description

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.

Key Responsibilities:

• 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.

Qualifications

Education:

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.

Required Experience and Skills:

• 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.

Preferred Experience and Skills:

• 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.

Required Skills:

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.

Required Skills:

Biomarker Development, Biomarker Discovery, Biomarker Identification, Biomarker Qualification, Biomarkers, Clinical Imaging, Clinical Pathology, Dedication to Patient Care, Disease Models, Disease Research, Imaging Biomarkers, Mechanism of Action, Medical Monitoring, Multiple Therapeutic Areas, Neurodegeneration, Neuroinflammation, Next Generation Science Standards, Personalized Medicine, Pharmaceutical Translations, Pharmacology, Professional Networking, Scientific Presentations, Scientific Writing, Translational Medicine

Salary Range:

$173,200.00 - $272,600.00

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.

Benefits:

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 .

Application Deadline:

The application deadline for this position is stated on this posting.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.