Senior Director, Biomarker Development, Strategy and Operations

Biomarker Strategy & Portfolio Leadership

Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways.

Establish biomarker frameworks spanning target engagement, PK/PD, and mechanism-of-action, disease biology, predictive, prognostic, and pharmacodynamic biomarkers.

Integrate preclinical, clinical, and emerging real-world data to drive indication selection and patient enrichment strategies.

Serve as biomarker SME on cross-functional program teams, shaping study design and endpoint selection.

Biomarker Development & Assay Leadership

Oversee the development, qualification, validation, and lifecycle management of fit-for-purpose biomarker assays (exploratory through regulatory-grade).

Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics).

Ensure scientific rigor, reproducibility, and compliance across all biomarker platforms.

Biomarker Operations & Execution

Own end-to-end biomarker operations across clinical studies, including vendor selection and oversight (CROs, central labs, diagnostics partners); budgeting, timelines, and risk management; sample flow logistics and assay execution.

Lead outsourcing strategy including assay transfer, validation, and execution at external partners.

Ensure high-quality, timely data delivery, including rigorous QC and data review.

Guide incorporation of biomarkers into clinical protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA).

External Partnerships & Scientific Leadership

Identify, select, and manage external collaborators (CROs, diagnostic companies, academic institutions).

Serve as external-facing scientific leader in biomarker strategy and translational medicine.

Support business development through scientific due diligence and biomarker strategy evaluation.

Contribute to scientific publications, conferences, and regulatory interactions.