About this role
Job title: Senior Director, Biomarkers (Immunology)
About the Role The Senior Director, Biomarkers, Immunology is an independent leader with broad scientific knowledge and expertise in immunology and biologics who will drive the biomarker strategy across immunology programs, including identification, selection, and development of biomarkers. Experience in authoring and supporting regulatory filings is required. The role also involves leading assay development and validation efforts and coordinating with internal teams and CROs to ensure fit-for-purpose biomarker assays.
What You'll Do
- Lead the development and execution of biomarker strategies in alignment with cross-functional stakeholders and senior management, with a focus on immunology and autoimmune disease programs.
- Oversee assay development, validation, and execution of biomarker assays across platforms (e.g., flow assays, immunoassays, genomic assays, NGS, imaging biomarkers) at CROs and internally, providing guidance on data analysis and interpretation.
- Serve as a specialized technical expert in biomarker development areas (e.g., CDx, immunoassays, genomic assays, flow assays) and lead specific work streams; mentor others within the team.
- Collaborate with regulatory teams to support filings and ensure alignment with regulatory expectations.
What We're Looking For
- PhD or MD in immunology, oncology, or a related field with extensive biomarker development and regulatory filings experience.
- Proven leadership and program-management abilities to drive biomarker strategies across cross-functional teams.
- Deep expertise in assay development and validation across multiple platforms; experience managing CRO partnerships and data analysis.
- Strong communication, collaboration, and mentoring skills; track record of delivering biomarker programs in immunology or autoimmune diseases.
Nice to Have
- Experience with companion diagnostics (CDx), imaging biomarkers, genomic assays, or flow cytometry.
- Familiarity with regulatory submissions involving biomarkers (INDs/BLAs) and risk-based decision making.