Clinical Trials Manager

Company Description

Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines.We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.

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 either Vancouver, BC OR Bellevue, WA OR Dublin, IRE OR New York, US and is hybrid with a minimum of 3 days per week onsite. This is a 12-month fixed term position.

What You'll Do

Clinical Trial Management:

• Acts as clinical trial lead on one or two early-phase clinical studies
• Maintains global study timelines and aligns study start-up, enrollment, study conduct and close out activities with corporate goals.
• Identifies and ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned clinical trial.
• Ensures study is carried out according to the study protocol, SOPs, CFR, ICH/GCP guidelines and study-specific manuals and procedures; collaborates with QA to ensure inspection readiness.
• Develops and implements study specific processes and trains study teams.
• Works closely with the study management team to develop clinical trial protocols and designs all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial.
• Prepares, reviews, and approves study-related documents (e.g., Monitoring plans, Laboratory Manual, Patient Diary and CRF completion guidelines).
• Proactively identifies study issues/risks and recommends/implements solutions for assigned clinical trial.
• Reviews and analyzes clinical data routinely to identify, develop and implement changes required for improvement and compliance at site level and/or study level.
• Develops and reviews site budgets working closely with finance and CRO partner.
• Plans and conducts, investigator meetings, internal team meetings, and other trial-specific meetings.
• Assists in the preparation and follow-up of in-house and on-site quality audits, as well as regulatory authority inspections.

Vendor and Site Management:

• Collaborates with CRO to manage site related interactions and serves as a liaison and resource for investigational sites. Troubleshoots and helps to address recruitment obstacles.
• Reviews CRO/vendor invoices for accuracy.
• Reviews and analyzes the initial and revised scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations (timeline/quality/cost) ar _e_ met with the CRO/vendor.

Clinical Trials Leadership:

• Manages assigned clinical trial with minimal oversight.
• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
• Develops and implements processes with efficiencies for assigned clinical study
• Fosters effective and collaborative working relationships with fellow employees, management, and external partners.
• Other related duties as required.

What You'll Brin

• University degree and relevant clinical trials experience in pharmaceutical, biotech or CRO setting including clinical trial management experience.
• Minimum of 5 years’ pharmaceutical industry drug safety experience, optimally in a small-to-mid cap biotech environment.
• An equivalent combination of education and experience may be considered.
• Prior experience in lead role of global clinical trials is required.
• CRO/vendor management and oversight experience are required.
• Oncology clinical research experience is preferred.
• Knowledge of and experience with international regulatory adverse event reporting requirements.
• Demonstrated line management experience.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Thorough knowledge of FDA/EMA, CFR and GCP/ICH requirements.
• Ability to work independently, establish functional priorities and execute on goals.
• Experience in oncology drug development desirable.
• Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%).

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:

• Exceptional medical, dental and vision benefits by country
• Industry leading vacation and paid time off

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.