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Company

Jazz Pharmaceuticals · 6 hours ago

Associate Director, Biomarker (Remote)

Carlsbad, CA

Full-time

Remote

Mid, Senior Level

$150K/yr - $224K/yr

5+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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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 leadership.

Qualification

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Pharmaceutical experienceBiomarker developmentImmuno-Oncology assaysCRO managementBiomarker data analysisCompanion diagnostic knowledgeClinical trial deliverablesRegulatory submissionsAssay validationPatient screening methodsCollaboration skills

Required

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).

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.

Benefits

Medical, dental and vision insurance

401k retirement savings plan

Flexible paid vacation

Company

Jazz Pharmaceuticals

Glassdoor

3.2

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.

Founded in 2003

Palo Alto, California, USA

1001-5000 employees

https://www.jazzpharma.com/

H1B Sponsorship

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2023 (18)

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2021 (28)

2020 (36)