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.
The Translational Sciences Department at Zymeworks Inc. is seeking highly motivated Research Scientist with expertise in Pharmacology/Toxicology. As a key team member, this role is responsible for the toxicology and pharmacokinetic studies needed to bring discovery candidates forward and to support development projects. The responsibilities include study design, dosage selection, study initiation and monitoring, data review, PK modelling and simulation, study reports and regulatory submissions. The position will report to the Director of Toxicology and will be based in either Vancouver, British Columbia. or Seattle, Washington.
- Design toxicology studies needed to support pharmaceutical development projects.
- Initiate studies at approved contract facilities following appropriate processes for protocol development, contract implementation, test article procurement, and timeline commitments.
- Monitor studies for accuracy and timely completion, audit raw data for accuracy, and review draft reports for completion.
- Ability to independently analyze, interpret and report clinical PK, PD and PKPD results for internal decision making and regulatory filings.
- Provide modeling and simulation support to project teams.
- Anticipate study problems and opportunities and raise issues with suggested resolutions to supervisor.
- Ensure appropriate project management and oversight for multiple CROs.
- Prepare verbal and written summaries of study reports for internal discussions.
- Contribute to various regulatory documents and ensure regulatory compliance.
Qualifications and Experience
- A minimum of 3 years of experience in the biotech/pharmaceutical industry in the area of nonclinical drug discovery and/or development
- A minimum of 3 years of experience as a toxicology Study Director or as a coordinator of toxicology programs at a pharmaceutical company.
- Strong research background with proven ability to contribute to the understanding of the pharmacologic/toxicologic mechanism(s) of drug-induced responses in animals.
- Ability to understand complex biologic pathways across multiple programs and identify key research activities of importance
- Working knowledge of GLP regulations, ICH and other regulatory guidance documents, and experience conducting, and monitoring toxicology studies are critical
- Proficiency in Win-NonLin an asse
- Experience in supporting drug development teams and preparing IND filings is beneficial
- Must be detail oriented with strong documentation and organizational skills, with a commitment to quality and accountability
- Strong oral communication skills and demonstrated proficiency at technical writing are essential
- Excellent organizational and project management skills required for extensive interactions with multiple CROs and external study monitoring responsibilities
- Effective problem-solving skills and judgment
- Proficient at working independently as well as in team settings
- An equivalent combination of education and experience may be considered.
- Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.
Education and Certification Requirements:
- DVM or Ph.D. or equivalent in Toxicology, Pathology, Pharmacology or related health science field strongly preferred; candidates with a M.S. degree will be considered if supported by additional years of demonstrated relevant experience.
- Certification by the American Board of Toxicology (DABT) strongly preferred
Why Work for Us?
At Zymeworks, we stand for innovation, integrity, collaboration and care.
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.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
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.