Brief Description:

The Executive Director, Biomarkers leads enterprise-wide biomarker strategy across the portfolio with an emphasis on oncology, covering companion diagnostics (including global regulatory strategy) and correlative biomarker plans for clinical and nonclinical research. The role integrates translational science, clinical development, biostatistics, and regulatory functions to enable precision medicine, patient stratification, and data‑driven decisions.

Essential Functions/Responsibilities

• Own the end-to-end biomarker strategy for oncology programs through design, execution, analyzing, and reporting correlative biomarker studies for clinical trials (Phase 0–3) and nonclinical work, including PK/PD, pharmacogenomic, immunophenotyping, and circulating biomarker readouts.

• Lead Companion Diagnostic (CDx) strategy: define intended use, select/manage diagnostic partners/CROs, oversee analytical/clinical validation, and align on regulatory pathways (e.g., PMA/510(k), IVDR).

• Embed patient selection/enrichment strategies and biomarker endpoints into protocols and SAPs in partnership with Clinical Development, Biostatistics, and Regulatory.

• Author/review biomarker plans, clinical protocols, IB/IND/IMPD sections, CDx submissions, and responses to health authority queries.

• Establish fit‑for‑purpose assays (tissue and liquid) and data standards; ensure chain‑of‑custody, quality, and compliance for biospecimens and data.

• Build and lead a high‑performing biomarker team; manage budgets, timelines, vendors, and academic collaborations.

• Communicate strategy, risks, and recommendations to R&D leadership; represent the company with partners, KOLs, and scientific consortia.

• Contribute to Search & Evaluation by assessing biomarker/CDx feasibility and translational rationale for external opportunities.

Required Knowledge, Skills, and Abilities

• Oncology experience REQUIRED with deep knowledge of tumor biology, heterogeneity, clinical development, and regulatory considerations.

• Non‑oncology biomarker experience PREFERRED (e.g., neuroscience) to cross‑pollinate best practices.

• Proven track record delivering biomarker strategies and CDx programs, including analytical/clinical validation and regulatory submissions

• Fluency in multi‑omic data (genomics, transcriptomics, proteomics, metabolomics) and molecular assay platforms (IHC/ISH, NGS, PCR, flow cytometry, mass spec, ctDNA).

• Experience designing correlative science for both clinical trials and nonclinical studies; ability to translate mechanism of action into measurable pharmacodynamic and patient‑selection hypotheses.

• Strong leadership in matrixed environments; ability to influence without authority and manage external partners/CROs.

• Excellent oral and written communication; ability to author and review technical and regulatory documents.

Required/Preferred Education and Licenses

• Education: Doctoral degree (PhD, MD, or MD/PhD) in molecular biology, genomics, bioinformatics, biomedical engineering, or related field, with significant experience in a drug development setting and significant oncology biomarker leadership.

• Preferred: ASCP/MGP or clinical laboratory certifications.