Executive Director, Biomarkers (Remote)
Jazz Pharmaceuticals
6 months ago
Remote
United States
Clinical Research and Development
Brief Description
- The Executive Director, Biomarkers leads enterprise-wide biomarker strategy across the portfolio with an emphasis on oncology, including companion diagnostics (global regulatory strategy) and correlative biomarker plans for clinical and nonclinical research.
Essential Functions/Responsibilities
- Own end-to-end oncology biomarker strategy for correlative biomarker studies (clinical trials Phase 0–3 and nonclinical), including PK/PD, pharmacogenomics, 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 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 tissue and liquid assays and data standards; ensure chain-of-custody, quality, and compliance for biospecimens and data.
- Build and lead the 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
- REQUIRED: Oncology experience with deep knowledge of tumor biology, heterogeneity, clinical development, and regulatory considerations.
- PREFERRED: Non-oncology biomarker experience (e.g., neuroscience).
- 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 assay platforms (IHC/ISH, NGS, PCR, flow cytometry, mass spec, ctDNA).
- Experience designing correlative science for clinical and nonclinical studies; ability to translate mechanism of action into pharmacodynamic and patient-selection hypotheses.
- Strong matrix leadership; 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; significant drug development experience and oncology biomarker leadership.
- Preferred: ASCP/MGP or clinical laboratory certifications.
Benefits (if explicitly stated)
- Eligible for medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application Instructions (if explicitly stated)
- If you are a current Jazz employee, apply via the Internal Career site.
- The Executive Director, Biomarkers leads enterprise-wide biomarker strategy across the portfolio with an emphasis on oncology, including companion diagnostics (global regulatory strategy) and correlative biomarker plans for clinical and nonclinical research.
Essential Functions/Responsibilities
- Own end-to-end oncology biomarker strategy for correlative biomarker studies (clinical trials Phase 0–3 and nonclinical), including PK/PD, pharmacogenomics, 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 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 tissue and liquid assays and data standards; ensure chain-of-custody, quality, and compliance for biospecimens and data.
- Build and lead the 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
- REQUIRED: Oncology experience with deep knowledge of tumor biology, heterogeneity, clinical development, and regulatory considerations.
- PREFERRED: Non-oncology biomarker experience (e.g., neuroscience).
- 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 assay platforms (IHC/ISH, NGS, PCR, flow cytometry, mass spec, ctDNA).
- Experience designing correlative science for clinical and nonclinical studies; ability to translate mechanism of action into pharmacodynamic and patient-selection hypotheses.
- Strong matrix leadership; 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; significant drug development experience and oncology biomarker leadership.
- Preferred: ASCP/MGP or clinical laboratory certifications.
Benefits (if explicitly stated)
- Eligible for medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application Instructions (if explicitly stated)
- If you are a current Jazz employee, apply via the Internal Career site.