Clinical Program Manager
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company. This position will be based in Seattle and will report to the Director, Clinical Operations.
- Plans and manages the overall execution of the assigned clinical program to meet necessary quality standards (including ICH GCP, local regulations), budget and timelines, including recommending operational strategies and/or decisions.
- Provides study-level direction to clinical trial manager(s) for the development of study management plans including enrollment models, risk management plans, financial planning and management, communications plans, and monitoring plans in collaboration with the CRO partner; collaborates with Director, Clinical Operations to ensure inspection readiness.
- Reviews and provides input into clinical documents, including investigator brochures, investigational new drug applications (INDs), study protocols, informed consent forms, clinical study reports.
- Partners with cross functional teams to manage, adjust and revise project deliverables, timelines/budgets as necessary.
- Responsible for program budget planning. Works closely with clinical study manager(s), project management, and finance to ensure on a regular basis that budgets, enrollment are accurate; communicates program status, cost and issues to ensure timely decision-making by senior management.
- Provides guidance and oversight for the successful management of all aspects of international clinical trials within the designated program budgets and timelines.
- Independently manages all components of assigned clinical program, including sponsor initiated and investigator-initiated studies.
- Analyzes and reports safety issues, patient care issues and study conduct issues.
- Communicates project status and escalates issues proactively.
- Provides functional expertise to author or contribute to SOP development.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
- University degree in health sciences or related discipline and a minimum of 5 to 7 years’ related experience (3 to 4 years’ management experience) in oncology drug development, hematology trials or an equivalent combination of education and experience.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment
- Experience in developing RFPs and selection and management of CROs/Vendors.
- Experience in managing staff as well as mentoring and developing junior staff is required.
- 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 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.
- Exceptional attention to detail.
- Effective communication and influencing skills and the 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 experience 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 20%).
- 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 opportunity, please apply by clicking "Apply Now". Due to the high volume of applicants, only those selected for interviews will be contacted