Clinical Program Manager
Clinical Program Manager
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
- Manages clinical trials, to ensure studies are initiated efficiently, completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
- Identifies and manages CROs and other study vendors.
- Works proactively with data management vendor to review metrics and follow up with clinical CRO for data currency.
- Works closely with CRO staff to ensure performance and deliverables according to contract and work orders.
- Monitors and manages clinical trial budget.
- Provides strategic guidance of junior staff on management of clinical studies.
- Ensures the creation and use of supportive study supplies and documents (e.g., ICF templates, lab manuals, lab kits, site study tools, pharmacy manuals).
- Ensures the TMF is properly maintained and archived.
- Analyzes and reports safety issues, patient care issues and study conduct issues.
- Liaises with Finance to review vendor invoices and approve payments.
- Partners with cross functional groups on trial requirements (e.g. IP supply, labeling, PK and biomarkers).
- Contribute in writing study protocols, sections for investigator brochures, regulatory documents (e.g. IND, NDA, etc.), abstracts and manuscripts.
- Communicates project status and escalates issues proactively.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
- Functional expertise to author or contribute to SOP development.
Education and Experience
University degree and a minimum of 8 years’ pharma/CRO industry experience in oncology drug development, hematology trials or an equivalent combination of education and experience.
Skills and Abilities
- Demonstrated ability to successfully develop, implement, manage and complete clinical trials.
- Knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Ability to lead through example and to establish an environment fostering effective and collaborative working relationships.
- Able to resolve problems using regulations, guidelines and investigator interaction.
- Knowledge of how the clinical trial operations impact the broader strategic goals.
- Able to anticipate problems and implement efficient solutions.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
- Exceptional attention to detail.
- Communication and influence skills and ability to create a clear sense of direction.
- Ability to manage, mentor and develop junior staff.
- Good analytical and assessment skills, judgement and problem solving skills.
- Global trial and CRO management preferred.
- Experience in all trial phases.
- Experience with RFP process and vendor selection.
- Previous experience with database build preferred.
- Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%).
- Proficiency with MS Office.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging and rewarding position, please email your resume and cover letter to email@example.com with “Clinical Program Manager” in the subject line.