Principal Scientist - Clinical Research, Immunology Biomarker Lead

MSD•Boston, MA

6d•$190,800 - $300,300•Hybrid

About The Position

The Principal Scientist will serve as an Immunology Biomarker Lead within Translational Clinical Biomarkers, providing strategic and scientific leadership for the design, execution, analysis, and communication of clinical biomarker strategies supporting the immunology clinical development portfolio. The role drives decision-centric strategies connecting drug mechanism, disease biology, precision medicine, pharmacodynamics, dose decisions, and clinical endpoints to inform program- and portfolio-level decisions throughout development. The position leads integrated biomarker strategies across discovery and early- and late-stage clinical programs, with clear hypotheses, fit-for-purpose endpoints, and links to development decisions. It represents biomarker strategy in cross-functional teams and governance forums, informs target validation, patient selection, and go/no-go decisions, and translates disease biology and therapeutic mechanisms into clinically actionable approaches. The role also leads biomarker sub-teams and working groups, champions analysis plans, interprets complex data, communicates findings to internal and external audiences, and supports publications, presentations, and KOL engagement as appropriate.

Requirements

PhD or MD in Immunology, Biology, or a related STEM field plus at least 7 years of immunology experience; or an MS plus at least 10 years of experience; or a BS plus at least 14 years of experience.
Deep expertise in immunology and immune-mediated or inflammatory diseases, with experience in at least one of rheumatology, gastrointestinal or mucosal inflammation, or dermatology.
A 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, including the ability to translate complex data into clear, decision-oriented insights.
Excellent communication skills.
Working knowledge of biostatistics, bioinformatics, and advanced data analytics.
Experience advancing precision medicine strategies.

Nice To Haves

Autoimmune diseases research and development experience.
Translational medicine experience.

Responsibilities

Lead and shape integrated biomarker strategies across discovery, early-stage, and late-stage clinical programs.
Define clear hypotheses, fit-for-purpose endpoints, and explicit links between biomarker strategies and key development decisions.
Serve as the biomarker strategy lead in cross-functional program teams and represent multidisciplinary teams in governance forums.
Develop biomarker strategies that address mission-critical questions for forward and reverse translation.
Inform portfolio strategy through biomarker-driven insights related to target validation, patient selection, and go/no-go decisions.
Translate disease biology and therapeutic mechanisms of action into clinically actionable biomarker strategies, including 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 working groups involving clinical, discovery, translational, regulatory, biostatistics, and data science functions.
Integrate diverse scientific perspectives into cohesive strategies and provide scientific leadership for hypothesis-driven, decision-focused biomarker work.
Champion biomarker analysis plans and provide scientific input into interpretation of complex datasets.
Communicate scientific insights to internal stakeholders, governance bodies, and external scientific audiences.
Support external engagement, including publications, presentations, and interactions with key opinion leaders, as appropriate.