Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
About the Position
Zymeworks is looking for a highly-motivated professional to join our Regulatory Affairs team. The Director, Drug Safety Operations will be responsible for adverse event management, study team support activities and aggregate periodic reporting to ensure global regulatory compliance during clinical trial conduct with all of Zymeworks’ products.
The Director, Drug Safety Operations will ensure vendor oversight, medical review and relevant risk management activities in collaboration with Regulatory, Clinical Affairs and/or other Development personnel.
This position will report to the Vice President of Regulatory Affairs and will be based in Seattle, WA.
- Manages SAE/SUSAR reporting activities for all investigational drugs
- Manages preparation and processing of internal and external SAE reports
- Triages incoming adverse events to determine action required
- Establishes department procedures and SOPs
- Selects, implements and validates a sponsor-held electronic safety database for tracking, storing, and reporting serious adverse events from Zymeworks’ clinical trials
- Ensures corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
- Collaborates with partners on the development of Pharmacovigilance Agreements and the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in those agreements
- Provides guidance and support to project teams for safety-related areas, including protocol development and study conduct
- Contributes to preparation of relevant sections of clinical study reports, periodic reports, expedited safety reports and other regulatory filing documents
- Authors risk sections for Investigator Brochures, DSURs, Protocols, ICFs, etc.
- Trains staff on drug safety principles and procedures
- Manages and mentors staff and assigns responsibilities as appropriate to meet timelines and quality metrics
- Responds to safety-related queries from regulatory authorities or Ethics Committees, if needed
- Ensures alignment among case handling, aggregate reporting, and signal detection activities
- Manages the budget and resources for the drug safety department
Qualifications and Experience
- Advanced degree in life sciences, nursing, pharmacy, or medicine and a minimum of 5 years’ pharmaceutical industry drug safety experience, optimally in a small-to-mid cap biotech environment or an equivalent combination of education and experience.
- Knowledge of and experience with international regulatory adverse event reporting requirements
- Demonstrated line management experience
- Hands-on experience with adverse event case processing in Argus/Aris-G database
- Proven experience and effectiveness at training and mentoring drug safety staff
- Excellent knowledge of MedDRA coding and WHODrug coding
- Ability to work independently, establish functional priorities and execute on goals
- Excellent interpersonal communication skills and ability to work effectively as part of teams
- Experience in oncology drug development desirable
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.