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About the Role
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 should focus on generating high-value, interpretable evidence that informs program decisions rather than data generation alone.
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.
- 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.
- 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.
Requirements
- Ph.D., M.D., or equivalent advanced scientific degree with relevant experience in translational medicine, biomarker science, drug development, or a related discipline.
- Significant experience developing and executing translational or clinical biomarker strategies in drug or vaccine development.
- Scientific expertise relevant to one or more areas within cardiovascular disease, metabolic disease, infectious diseases, vaccines, immunology, 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 cardiovascular/metabolic drug development and/or infectious disease and vaccine development.
- Experience working across multiple programs or therapeutic areas.
- Experience mentoring or providing scientific direction to other scientists.
- US and Puerto Rico Residents Only
- 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
Skills
- Biomarkers
- Cardiovascular Diseases
- Clinical Development
- Clinical Research
- Clinical Study Design
- Data Translation
- Ethical Compliance
- Ethical Standards
- Immuno-Oncology
- Mechanism of Action
- Patient Care
- Personalized Medicine
- Pharmacodynamics
- Scientific Presentations
- Scientific Writing
- Strategic Thinking
- Translational Medicine
Location
- Domestic
Work Type
- Hybrid
- Regular
Experience Level
- Principal
Education Level
- Ph.D.
- M.D.
- Equivalent advanced scientific degree
Salary/Compensations
- $190,800.00 - $300,300.00
Benefits
- Medical
- Dental
- Vision healthcare
- Other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Equal Opportunity
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement
- Learn more about your rights, including under California, Colorado and other US State Acts