Scientist, Biomarkers

Work Requirement

This role will be based out of our Bellevue, WA office and is hybrid with a minimum of 3 days per week onsite. 

Key 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.
   

Education and Experience

• 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.

Skills and Abilities:

• 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. US, EU, APAC) is a plus.
• Expertise with a wide range of clinical biomarker sample types (e.g. FFPE tumors, serum, plasma, PBMC, ctDNA) and methods (e.g. IHC, ISH, NGS, Flow cytometry, MSD, Olink, spatial proteomics) is preferred.
• Experience with sample management software, Spotfire dashboards, JMP, GraphPad analytical software.
• Leadership skills and demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, internal and external teams to support clinical development strategy. 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.
• 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.