Jazz Pharmaceuticals

Executive Director, Biomarkers (Remote)

Jazz Pharmaceuticals$276K — $414K *
US-AnywhereRemote in Pennsylvania, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of oncology experience with extensive knowledge of tumor biology and regulatory considerations.
  • Proven success in delivering biomarker strategies and regulatory submissions.
  • Familiarity with multi-omic data and molecular assay platforms.
  • Strong background in designing correlative science for clinical and nonclinical studies.
  • Exceptional leadership skills in matrixed environments with proficiency in managing CROs.

Responsibilities

  • Own the comprehensive biomarker strategy for oncology programs.
  • Lead Companion Diagnostic strategy and manage diagnostic partners.
  • Embed patient selection strategies into clinical protocols.
  • Author and review key regulatory documents and submissions.
  • Establish data standards and ensure compliance for biospecimens.
  • Build and manage a high-performing biomarker team.
  • Communicate strategies and risks to R&D leadership.

Benefits

  • Medical, dental, and vision insurance.
  • 401k retirement savings plan.
  • Flexible paid vacation.
  • Discretionary annual cash bonus eligibility.
  • Discretionary equity grants available.
Full Job Description

If you are a current Jazz employee please apply via the Internal Career site

Job Description

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 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 - $414,000.00

Individual 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

About Jazz Pharmaceuticals

Jazz Pharmaceuticals is a biopharmaceutical company that develops and commercializes medicines for patients with serious diseases. The company's portfolio of products and product candidates is focused on neuroscience and oncology therapeutic areas. Jazz Pharmaceuticals was founded in 2003 and is headquartered in Dublin, Ireland.
Learn more about Jazz Pharmaceuticals
Size
3,200 employees
Market Cap
$10.1 billion
Industry
Net Income
$238.6 million
Founded
2003
5 Year Trend
+15.8%
Revenue
$2.3 billion
NASDAQ

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