Principal Scientist - Clinical Research, Immunology Biomarker Lead
Merck
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Job summary
Merck in Cambridge, MA seeks a Principal Scientist (Director) to lead Immunology Biomarker strategies within Translational Clinical Biomarkers. You will design and guide biomarker programs, linking drug mechanism to clinical endpoints and decision-making across development lifecycles.
The role requires deep immunology expertise, strong data interpretation, and leadership to align multiple functions in a fast-paced environment, with cross-disciplinary collaboration and external engagement as
Qualifications
- Asking for PhD/MD with 7+ years in Immunology; MS with 10+ years; BS with 14+ years in related fields.
- Deep expertise in immune-mediated/inflammatory diseases including rheumatology or GI; autoimmune R&D preferred.
- Strong cross-functional leadership and ability to drive translational strategies.
Responsibilities
- Lead and shape immunology biomarker strategies across programs with clear hypotheses and endpoints.
- Represent biomarker strategy in governance forums and cross-functional teams.
- Translate biology into clinically actionable biomarker plans and surrogate endpoints.
- Drive innovative biomarker approaches aligned with clinical utility and decisions.
- Collaborate with discovery, translational medicine, regulatory, bio-stats and data science teams.
Skills
Education
Job description
We are seeking an accomplished and highly motivated Principal Scientist (Director) to serve as an Immunology Biomarker Lead within Translational Clinical Biomarkers. This role provides strategic and scientific leadership in the design, execution, analysis, and communication of clinical biomarker strategies in support of the immunology clinical development portfolio.
We are seeking an accomplished and highly motivated Principal Scientist (Director) to serve as an Immunology Biomarker Lead within Translational Clinical Biomarkers. This role provides strategic and scientific leadership in the design, execution, analysis, and communication of clinical biomarker strategies in support of the immunology clinical development portfolio.
The successful candidate will drive decision-centric biomarker strategies that connect drug mechanism, disease biology, precision medicine, pharmacodynamics, dose decisions, and clinical endpoints, directly informing program- and portfolio-level decisions across the development lifecycle.
This role requires deep scientific expertise, structured decision-making, sophisticated data analysis & interpretation; and cross-functional collaboration, aligning diverse stakeholders in a fast-paced, matrixed environment.
- Lead and shape integrated biomarker strategies across discovery, early- and late-stage clinical programs, ensuring clear hypotheses, fit-for-purpose endpoints, and explicit linkage to key development decisions, in close collaboration with cross-functional leaders, particularly in Discovery, Late Stage Clinical Development and across Translational Medicine.
- Serve as the biomarker strategy lead within cross-functional program teams and represent multi-disciplinary team(s) in governance forums, ensuring biomarker strategies to address mission-critical questions for both forward and reverse translation.
- Inform portfolio strategy by advancing biomarker-driven insights that inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and therapeutic mechanism of action into clinically actionable biomarker strategies addressing critical program questions, e.g. proof of biology, pharmacodynamic effects, precision medicine and surrogate endpoints for efficacy.
- Drive selection and application of innovative biomarker approaches, aligned with biological rationale and clinical utility.
- Lead biomarker sub-teams and related working groups, including clinical, discovery, translational, regulatory, bio-stats, and data sciences.
- Collaborate effectively across disciplines to integrate diverse scientific perspectives into cohesive strategies.
- Provide scientific leadership to enable hypothesis-driven, decision-focused biomarker strategies.
- Champion biomarker analysis plans and provide critical scientific input to the interpretation of complex datasets to deliver scientifically rigorous and clinically meaningful conclusions.
- Clearly articulate insights to internal stakeholders, governance bodies, and external scientific audiences.
- Support external engagement, including publications, presentations, and KOL interactions, as appropriate.
- PhD or MD in Immunology, Biology, or related STEM degree with 7+ years experience in Immunology; MS and 10+ years of experience, or BS and 14+ years of experience. Autoimmune Diseases R&D and/or experience in translational medicine strongly preferred.
- Deep expertise in immunology and immune - mediated/inflammatory diseases, with experience in at least one of the following:
- Rheumatology.
- Gastrointestinal/mucosal inflammation.
- Dermatology.
- Proven track record of driving translational strategies that inform clinical development decisions, including close cross-functional collaboration and partnership.
- Demonstrated ability to lead highly matrixed teams.
- Strong analytical and problem-solving capabilities, with the ability to translate complex data into clear, decision-oriented insights.
- Excellent communication skills.
- Working knowledge with biostatistics, bioinformatics, and advanced data analytics.
- Experience advancing precision medicine strategies.
- Strategic mindset with a focus on decision impact rather than data generation alone.
- Strong leadership presence and ability to influence cross-functional stakeholders.
- Proven ability to operate effectively in a fast-moving, matrixed environment.
#EligibleforERP
Biomarker Development, Biomarker Discovery, Biomarker Identification, Biomarker Qualification, Biomarkers, Clinical Development, Clinical Research, Dermatology, Gastroenterology, Gastrointestinal Disease, Immunogenicity, Immunology Research, Immuno-Oncology, Inflammatory Diseases, Omics, Personalized Medicine, Pharmacodynamics, Protocol Development, Rheumatology, Translational Medicine
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
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 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. Learn more about your rights, including under California, Colorado and other US State Acts
Regular
Domestic
No
10%
Hybrid
Not Indicated
No
n/a
11/6/2026
- 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.
Requisition ID: R421063
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