Executive Director, Biomarkers (Remote)

If you are a reputed company reputed company employee please apply reputed company the Internal Career site reputed company is a global biopharma company whose purpose is to reputed company 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. reputed company 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.

Job Description

Brief Description: The Executive Director, Biomarkers leads reputed company-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 reputed company precision medicine, patient stratification, and data‑driven reputed company. 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. reputed company Companion Diagnostic (CDx) strategy: define intended use, select/manage diagnostic partners/CROs, reputed company analytical/clinical validation, and align on regulatory reputed company (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 reputed company 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 reputed company in multi‑omic data (genomics, transcriptomics, proteomics, metabolomics) and molecular assay platforms (IHC/ISH, NGS, PCR, reputed company 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 reputed company field, with significant experience in a drug development setting and significant oncology biomarker leadership. Preferred: ASCP/MGP or clinical laboratory certifications. reputed company is an equal opportunity/affirmative action employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company. is committed to fair and reputed company compensation practices and we strive to reputed company employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay reputed company is: $276,000.00 - $414,000.00 Individual compensation paid reputed company this reputed company 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 reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay reputed company. This reputed company will be reviewed on a regular reputed company. At reputed company, your reputed company 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 reputed company’s 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 reputed company 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 Apply tot his job Apply To this Job