Clinical Trials Manager

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) 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.
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.
Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.
Work Requirement
This role will be based out of our San Francisco (Redwood City) office and is hybrid with a minimum of 3 days per week onsite.
Key Responsibilities
Clinical Trial Management:

• Acts as a Clinical Trials lead on designated clinical studies, working in close collaboration with the global Clinical Operations team.
• Maintains 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 clinical program manager to ensure inspection readiness.
• Develops and implements study specific processes and trains study teams.
• Works closely with project teams 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.
• Leads and manages CRAs to review monitoring reports and monitoring visit letters to assess trends and site performance.
• Reviews and analyzes clinical trial 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.
• Collaborates with the Clinical Operations team to reviews and analyze the initial and revised scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations (timeline/quality/cost) ar 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.
• May manage employees. Monitors performance encourages growth and facilitates the development of team members.
• 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.

Education and Experience

• 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
• Global Clinical Trials experience ex-North America in one of either EMEA or APAC strongly preferred.
• An equivalent combination of education and experience may be considered.
• Thorough knowledge of FDA/EMA, CFR and GCP/ICH requirements.
• People management experience required.
• 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.

Skills and Abilities:

• Knowledge of and experience with international regulatory adverse event reporting requirements
• 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.
• Ability to work independently, establish functional priorities and execute on goals
• Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%).
• Embody and champion Zymeworks' values: Innovate. Act with Integrity. Collaborate. Care.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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 US base salary range for this full-time position is $113,000 - $173,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. 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).
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes:

• Industry leading vacation and paid time off
• Excellent health and wellness benefits
• Zymelife health and wellness benefits
• Paid time off to volunteer in your community
• Matching RRSP / 401K program
• Employee Share Purchase Program
• Employee Equity Program

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.
Date: Feb 6, 2024