Director, Global Safety Operations
Director, Global Safety Operations
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.
Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.
- Collaborates with senior management team to develop and implement strategy, direction and priorities of pharmacovigilance activities. Ensures department and operational activities are aligned with corporate objectives
- Serves as the safety expert for all products globally and is accountable for the safety strategy and major safety deliverables, safety profile and product-related decisions and deliverables for assigned products.
- Contributes to clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data.
- Conducts medical review of individual case safety reports including appropriate follow-up requests and accuracy and timeliness of expedited reports.
- Leads product benefit-risk assessment discussions and updates reference safety information or risk minimization actions.
- Prepares safety information supporting licensing partners, reviews safety documents prepared by licensing partners, and communicates with licensing partners on safety matters per the safety agreement.
- May manage employees. Monitors performance, encourages growth and facilities the development of team members’ skills through training, mentorship opportunities and sharing of knowledge.
- Contributes to the successful implementation, execution and maintenance of safety processes and systems ensuring conformance with the company’s business strategy, industry standards and compliance with global regulations.
- Manages the preparation of operating and personnel budgets and plans. Authorizes expenditures, oversees forecasting activities and communicates anticipated variances to senior management, as required.
- Leads through example to establish an environment foster effective and collaborative working relationships.
Qualifications and Experience
- MD and a minimum of 10 years’ related experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry 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 with key stakeholder groups
- Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a rapidly growing organization
- In-depth product safety knowledge in the bio/pharmaceutical industry regulatory agency
- Extensive post-marketing safety experience
- Expertise in international regulations governing drug safety (US and EU) for pre- and post-marketing
- Experience with oncology products/early development
- Strong conflict management and negotiation skills
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment
- Able to think and act strategically, anticipate road-blocks and orchestrate plans to resolve issues and mitigate risks
- Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information.
- Strong oral, written and listening skills
- Demonstrated high level of integrity and ethics
- 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 http://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 forward your cover letter and resume to firstname.lastname@example.org.
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