Principal Scientist - Clinical Research, Immunology Biomarker Lead

Primary Responsibilities

Strategic Leadership & Program Impact

• 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.

Cross-functional Leadership & Alignment

• 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.

Data Interpretation & Communication

• 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.

Position Qualifications

Required Experience and Skills: 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.

Key Success Factors

• 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.