Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) R&D and clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA.
Why Work With Us
Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.
What You'll Do
- The Senior Scientist, Pathology is responsible for development and implementation of robust histology-based biomarker assays in support of oncology clinical programs for novel biologic drugs (eg. TCE, ADC) starting from preclinical stage through Phase 1/2 clinical trials.
- Provides training, technical guidance to preclinical, and clinical study teams to establish and analyze tissue-based biomarker assays.
- Serves as a resident subject matter expert for internal and external CROs studies using histology based exploratory and diagnostic assays.
- Evaluates and scores IHC, IF, in situ hybridization and special stains, as needed.
- Reviews and develops IHC procedures and threshold/cut-offs for patient selection in early phase clinical trials.
- Reviews Statements of Work (SOW) from biomarker testing vendors to ensure optimal performance of CROs.
- Develops infrastructure and delivers biomarker specimen and testing strategy for transition from preclinical to clinical in accordance with the requirements of quality, ethical and regulatory standards, including ICH/GDPR/GXP and CAP/CLIA guidance.
- Collaborates with other scientists on R&D-wide initiatives and research projects.
- Additional pathology-related responsibilities as assigned.
What You'll Bring
- PhD in Pathology, Biology, Medical Technology, Oncology, or related sciences plus 5-7 years of relevant work experience in pathology, biomarker development, testing and validation, or an equivalent combination of education and experience.
- Board certification in pathology preferred but not required
Deep knowledge and understanding of developing histology methods used in preclinical and clinical studies.
Experience with Oncology and/or Immunology is preferred.
Working knowledge of FDA & CAP/CLIA regulations. Familiarity with IVD regulations (e.g. IVDD/IVDR) from global regions (e.g. US, EU, APAC) is a plus.
Experience migrating and scaling diagnostic assays from research settings to clinical or clinical-research settings is preferred.
Knowledge and experience in digital pathology is highly desirable.
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, learn and implement pathology capabilities.
Total Rewards
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Our total rewards package that includes:
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits by country
- Zymelife health and wellness benefits
- Matching RRSP / 401K / Pension program
- Employee Share Purchase Program
- Employee Equity Program
- Paid time off to volunteer in your community
This role is not eligible for relocation or immigration support.
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.