Principal Scientist - Clinical Research, Immunology Biomarker Lead

MSD•Boston, MA

4d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.