Scientist, Biomarkers

Zymeworks

Bellevue, WA (+1 other)Full-time

Behavioral Health Market Context

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Benefits

Total Rewards We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growthThe US base salary range for this full-time position is $97, - $, + bonus + equity + benefitsOur salary ranges are determined by role, level, and locationThis role is also eligible for a competitive benefits package that includes:Industry leading vacation and paid time offExcellent health and wellness benefitsZymelife health and wellness benefitsPaid time off to volunteer in your communityMatching RRSP / K programEmployee Share Purchase ProgramEmployee Equity Program8 more items(s)

Qualifications

  • •BS, MS or PhD in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy or related pharmaceutical sciences
  • •A combined total of 10+ years of education and relevant work experience in drug development, biomarkers clinical trial management, testing and validation
  • •Deep knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
  • •Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling
  • •Familiarity with IVD regulations (e.g
  • •IVDD/IVDR) from global regions (e.g
  • •Expertise with a wide range of clinical biomarker sample types (e.g. FFPE tumors, serum, plasma, PBMC, ctDNA) and methods (e.g
  • •Strong attention to details, timelines, and quality
  • •Work successfully under pressure with tight timelines
  • •Proven critical reasoning skills including the identification and resolution of complex problems
  • •Eager to grow, develop capabilities, learn and implement novel biomarker testing platforms
  • •8 more items(s)

Responsibilities

  • •Collaborate with preclinical/clinical study teams to develop Clinical Biomarker Strategy Plans
  • •The Clinical Biomarker Lead will be accountable for robust clinical biomarker strategic, operational planning, and execution in support of oncology clinical programs for novel biologic drugs (eg TCE, ADC) starting from preclinical stage through Phase 1/2 clinical trials
  • •Provide functional SME, operational support to specialty CROs for safety, PD, exploratory and patient screening / enrollment biomarkers and Companion Diagnosis (CDx) development
  • •In close collaboration with clinical study teams, select functional biomarker testing vendors for clinical studies with strong scientific and business rationale and a focus on quality
  • •Solicit, review Statement of Work (SOW) from biomarker testing vendors; work with contract, legal specialists, procurement to ensure timely execution of contracts, SOWs, lab manuals
  • •Deliver biomarker specimen and testing strategy in accordance with the requirements of quality, ethical and regulatory standards, including ICH/GDPR/GXP and CAP/CLIA guidance
  • •Provide input into clinical protocols, informed consent forms, central/specialty laboratory documents to ensure accurate and precise implementation, operationalization, testing of clinical biomarker assays
  • •Function as key point of contact for multiple biomarkers testing vendors
  • •Responsible for forging and managing strong relationships with vendors to ensure timely clinical sample receipt, sample testing and biomarker data transfers to meet downstream data analysis timelines
  • •In close collaboration with CRO, CTM/CTA ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples
  • •Address questions from the clinical CRO or testing vendors as it relates to biomarker sample collections and/or queries, testing, storage, disposition
  • •In close collaboration with Biometrics Data Manager, accountable for the timely finalization of Data Transfer Guidelines, and transfer of data from testing vendors or Zymeworks (or clinical CRO) to meet clinical trial and translational timelines
  • •Work effectively in a dynamic operational environment with global cross-functional stakeholders
  • •Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update team members, stakeholders, and management on progress, address questions and issues, as well as interfacing with external vendors
  • •11 more items(s)
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