Why Work for Us?
Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care
We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Zymeworks is a 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.
Zymeworks is seeking a highly motivated Director of Toxicology to help advance its preclinical programs. This position will be critical in shaping preclinical drug development strategy and IND-enabling programs. This individual will also play a key role in liaising with global pharmacovigilance to ensure safety of our clinical assets.
This position will report to the Head of Scientific Research and Development and will be based in Vancouver, BC. / Seattle, WA.
As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.
- Responsible for developing overarching toxicology strategy and corporate toxicology policies and serve as subject matter expert for toxicology, pharmacokinetics and pharmacodynamics of small and large molecule therapeutics.
- Oversee toxicology staff in their execution of toxicology studies
Provides operational direction and oversight to ensure that toxicology studies adhere to appropriate guidelines and regulatory test standards.
- Oversees and evaluates protocol preparation for toxicology studies.
- Ensures that all safety testing plans, registration activities, regulatory submissions, and design control activities are addressed in accordance with Research and Development requirements.
- Provides leadership and oversight of Toxicology participation in cross-functional teams.
- Contributes to non-clinical safety strategy of novel therapeutic candidates, delineating the toxicity of the company’s platforms from target-related toxicities.
- Ensures immediate communication and cross-functional investigation of safety issues as they emerge.
- Responsible for resource planning and management, maintaining current testing procedures, program development, performance monitoring, and budget planning.
- Engages with regulatory bodies to present data and interpretations, and to provide detailed science-based responses to regulatory questions.
- Serves as part of the global pharmacovigilance team ensuring the safety of clinical stage drugs.
Qualifications and Experience
- PhD in Toxicology/Pharmacology or Biological Sciences with 10+ years of industry experience in conducting biologics and pharmaceuticals research and development, or an equivalent combination of education and experience.
- Demonstrated experience authoring regulatory submissions, including BLA/NDAs and INDs.
- An equivalent combination of education and experience may be considered.
- 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.
Skills and Abilities:
- Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.
- Utilizes a deep understanding of QA, Regulatory, CMC and Clinical functions to guide key preclinical activities.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Ability to think and act strategically, anticipate road-blocks, and map out next steps.
- Demonstrated high level of integrity and ethics.
- Strong analytical reasoning ability.
- Proficiency with MS Office.
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.