Executive Director, Biomarkers (Remote)

Jazz Pharmaceuticals•US - Home-Based - PA, PA

1d•$276,000 - $414,000•Remote

About The Position

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. 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.

Requirements

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

Nice To Haves

Non‑oncology biomarker experience PREFERRED (e.g., neuroscience) to cross‑pollinate best practices.
ASCP/MGP or clinical laboratory certifications.

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.