Associate Director, Clinical Pharmacology
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 Associate Director, Clinical Pharmacology who is looking to grow their career with our company.
This position will report to Senior Director, Pharmacokinetics and will be located in Seattle.
Job Description and Responsibilities
- Lead the clinical pharmacology development team, strategy and execution.
- Represent clinical pharmacology across studies, attend study team meetings and be the in-house subject matter expert for clinical pharmacology.
- Collaborate across departments and CROs to drive clinical pharmacology studies and high-quality clinical study reports completion.
- Plan and strategize interactions with regulatory agencies.
- Presentation of results at different forums (cross-functional teams, department meetings, governance meetings, conferences, etc.).
- Direct and implement methods to enable first in human dose selection and prediction using modeling & simulation.
- Contribute and author to the planning, implementation and preparation of regulatory filings and responses (e.g. IND, BLA, NDA, sNDA) and represent Clinical Pharmacology in regulatory meetings (e.g. End of Phase 2, pre-BLA/NDA, etc.)
- Lead and advise current clinical pharmacology principles, regulatory guidance and PK-PD methodologies.
- Publish manuscripts and posters, present at scientific conferences, and other scientific forums.
- MD or PhD, PharmD, or MS degree in pharmaceutical science, clinical pharmacology, pharmacy, biomedical engineering, or a related field.
- 5 year’s experience working as a clinical pharmacologist in the pharmaceutical industry.
- Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (e.g. NONMEM, Phoenix, R) is desired.
- Direct regulatory experience with FDA and other agencies is preferred
- Experience leading Clinical Pharmacology strategy for oncology programs in early development; experience with late-stage programs (e.g., pivotal trial design, NDA/MAA filings) is desired.
- Experience leading a clinical pharmacology team desired
- Excellent oral and written communication skills as evidenced by presentations at scientific meetings and publications in peer-reviewed journals.
- Willingness to challenge current paradigms and create new clinical and regulatory pathways to approval and commercialization.
- Team player, self-starter, high professional integrity and commitment to excellence.
- Effective at building alliances across functions.
- An equivalent combination of education and experience may be considered.
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.
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.