Primary Responsibilities
- Lead and shape integrated immunology biomarker strategies across discovery and early/late clinical programs, defining hypotheses, fit-for-purpose endpoints, and links to key development decisions.
- Serve as biomarker strategy lead in cross-functional program teams and governance forums; address mission-critical forward and reverse translation questions.
- Advance biomarker-driven insights to inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and mechanism of action into clinically actionable biomarker strategies (proof of biology, pharmacodynamics, precision medicine, surrogate endpoints).
- Lead biomarker sub-teams (clinical, discovery, translational, regulatory, bio-stats, data sciences), integrate perspectives, and drive hypothesis-driven, decision-focused plans.
- Champion analysis plans; interpret complex datasets and communicate insights to internal and external stakeholders (publications/presentations/KOLs).
- Mentor and develop team members.
Qualifications
- Ph.D. or M.D. with 12+ years in Immunology or related discipline; experience with autoimmune diseases and/or translational medicine.
Required Experience/Skills
- Deep immunology expertise in immune-mediated/inflammatory diseases (GI/mucosal inflammation, rheumatology, or dermatology).
- Track record driving translational strategies for clinical development decisions; lead matrixed organizations.
- Strong analytics and decision-oriented problem-solving; excellent communication.
- Working knowledge of biostatistics, bioinformatics, and advanced data analytics.
Preferred
- Precision medicine strategy experience; direct managerial experience.