Biomarker Bioanalytical Lead - Senior Scientist/Senior Manager

111918
  • 84340 USD - 138054 USD
  • Carlsbad, United States
  • Permanent

ABOUT:
My client is a leader in RNA-targeted therapy working within antisense technology. Their platform continues to transform drug discovery and transform the lives of patients with unmet needs.

RESPONSIBILITIES:

  • Responsible for executing the biomarker operations and strategy with excellence for assigned programs. Including managing biomarker assays at CROs, ensuring CROs meet all key deliverables and timelines.
  • Lead outsourcing activities; 1. Evaluate and select CRO 2. Develop and/or validate biomarker assay 3. Execute SOWs, validation plans, methods, and reports. 4. Collaborate with Clinical team throughout clinical sample analysis
  • Communicate effectively and timely with team members and senior management regarding project status, timelines, milestones, key events, and changes to the development plan.
  • Independently provides oversight of biomarker assay performance during clinical study conduct at CROs, ensures CRO maintains sufficient supply of critical reagents for uninterrupted clinical sample analysis, ensures timely delivery of high-quality biomarker data to meet program deliverables, and supports documentation preparation for regulatory submissions.
  • Provide technical/scientific writing support for:
    • validation plans and reports
    • bioanalytic sample analysis plans
    • regulatory documents
  • Review of clinical documents including study protocols, LSA, QRC, and any other study related documentation pertaining to sample collection and storage.
  • Represent Biomarkers in operational meetings and research meetings which include being readily available to advise on biomarker or study related updates and questions

QUALIFICATIONS:

  • Candidate should have hands on experience using immunoassays (ELISA, MSD, etc) and/or Mass Spec
  • Comprehensive knowledge of fit-for purpose assay validation based on clinical context of use.
  • Experience in life science research, with a basic understanding of mechanism of action of disease
  • Excellent communicator who is comfortable leading meetings and maintaining open and effective lines of dialogue, address problems and collaborate with team members, external vendors as well as senior management
  • Requires a minimum of 5 years of related experience with a bachelor’s degree, 2-3 years with MS, or PhD
  • Must be organized, adaptive, and detail oriented, with the ability to manage multiple competing priorities
  • Proven ability of being productive and successful in an intense work environment ?
  • Candidate can be located in San Diego or be fully remote
  • Travel minimal 0-10%
To learn more contact:
lauren.waybright@peoplewithchemistry.com
858-609-8549

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