Qualifications
Responsibilities
Benefits
If you are a current Jazz employee please apply via the Internal Career site
Job DescriptionBrief 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 data0driven 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 fit0for0purpose assays (tissue and liquid) and data standards; ensure chain0of0custody, quality, and compliance for biospecimens and data.
Build and lead a high0performing 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 REQUIREDwith deep knowledge of tumor biology, heterogeneity, clinical development, and regulatory considerations.
Non0oncology biomarker experience PREFERRED(e.g., neuroscience) to cross0pollinate best practices.
Proven track record delivering biomarker strategies and CDx programs, including analytical/clinical validation and regulatory submissions
Fluency in multi0omic 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 patient0selection 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 experiencein a drug development setting and significant oncology biomarker leadership.
Preferred:ASCP/MGP or clinical laboratory certifications.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.For this role, the full and complete base pay range is:
$276,000.00 - $414,000.00Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz0s Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html
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