Associate Director, Biomarker (Remote)

Company: Disability Solutions
Location: Carlsbad
Posted on: January 26, 2025

Job Description:

If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description: This individual will be responsible for supporting our Oncology Clinical Biomarkers and Companion Diagnostic (CDx) efforts, including study design, method and vendor selection, data interpretation, and reporting to support international drug development programs. The individual will collaborate across several global internal clinical studies and with external CROs, partners, working closely with Translational Sciences, Clinical Development (Clinical Operations, Data management, DMPK and Safety), Regulatory and Alliance Management global teams to ensure successful delivery of Clinical Biomarkers and Companion Diagnostics (CDx) goals in support of Phase2/3 trials. Have a broad understanding of new technological advances in Immuno-Oncology and potential utilization of these to address current and future needs within the Oncology Portfolio.Essential Job Functions:Job Responsibilities

• As Clinical Biomarker leader drive development and implementation of the Clinical Biomarker testing plans, patient screening/enrollment and CDx strategies on multiple oncology programs, in alignment with the Drug Clinical Development goals and timelines.
• Evaluate technologies to define and implement fit for purpose biomarker assays to support the clinical development of Jazz Pharmaceuticals oncology pipeline.
• Work in collaboration with oncology research teams to support overall biomarker assay development strategies across solid tumors and bring a deep understanding of relevant biomarker technologies, existing and emerging, to clinical development teams.
• Identify and manage consultants, partners and vendors supporting Biomarkers/CDx testing.
• Biomarker data analysis, interpretation, reporting of data for internal and external reports.
• Contribute to the preparation and review of relevant sections of clinical protocols, ICFs, contracts, study and data transfer plans, laboratory manuals, regulatory submissions.
• Address routine queries from sites/CROs, regulatory agencies during reviews/inspections.
• Effectively communicate the strategy, risks, mitigation plans and results to R&D leadershipRequired Knowledge, Skills, and Abilities
  • MS or PhD and at least 5 years pharmaceutical/biotechnology experience as Biomarker / CDx / Translational lead supporting global oncology clinical trials.
  • Hands on experience in Immuno-Oncology assays, such as NGS, IHC/ISH, Flow cytometry, multiplex IF, MSD, and familiarity with patient screening / enrollment testing methods.
  • Solid experience in CRO management, biomarker assay selection, qualification/validation, familiarity with assay development and testing under regulated environment (CLIA/CAP, GXP or equivalent) is preferred.
  • Strong understanding of companion diagnostic requirements, both in the US and abroad.
  • Ability to bridge early translational science data to clinical performance of predictive and prognostic biomarkers, CDx development in support of global drug development and clinical trial deliverables.
  • Ability to work both independently and collaboratively across global functional teams.
  • Excellent written and oral communication skills including good presentation skills.
  • Collaborative and flexible in personal interactions at all levels of the company.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLYJazz 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: $149,600.00 - $224,400.00Individual 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 Jazz'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 vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

Keywords: Disability Solutions, Los Angeles , Associate Director, Biomarker (Remote), Executive , Carlsbad, California