Job Req ID:  681

Seattle, WA, USA

Additional Locations:  Vancouver
Department:  Clinical Pharmacology

Associate Director, Clinical Pharmacology / Pharmacometrics

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, biospecific 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.  


Why Work With Us

Nothing is more critical to our success than the quality of our team.   The work we do is meaningful and impactful - we care about each other as well as the patients we serve.  We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.  


This position will report directly to the Senior Director, Clinical Pharmacology and Translational Sciences, and will be responsible for the design, leadership, and implementation of Clinical Pharmacology and Modeling & Simulation strategies across Zymeworks clinical and preclinical programs. This position will work in close partnership with colleagues in Clinical Development, Clinical Operations, Biostatistics, Nonclinical Development, Bioanalysis, Medical Affairs, Technical Operations, and Regulatory Affairs to execute the company’s overall development strategy. The successful candidate will have good quantitative pharmacology skills, scientific reasoning, regulatory affairs skills, written and verbal communication skills, exploratory graphical analysis skills, study design and report writing skills.


This individual will utilize a variety of analytic software to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information for PK/PD and Modeling and Simulation (M&S) analyses. This position will also work closely with other members of the Biometrics team to provide programming support across clinical development programs. The successful candidate will be familiar with quantitative approaches in drug development and have hands-on experience with relevant software (e.g. SAS, R).


Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Seattle, WA and Dublin, Ireland.  We offer a hybrid work environment with most team members working in-office three days per week.


Key Responsibilities

  • Act as Clinical Pharmacology Lead in the project team and other sub-teams as appropriate.
  • Provide the clinical pharmacology components of clinical development plan and provide clinical pharmacology expertise to the project team including planning, designing and overseeing clinical pharmacology studies with operational assistance from Clinical Operations.
  • Plan, write, and review the clinical study designs, study protocols, data analysis plans, study reports, and regulatory documents such as IBs, INDs, briefing books for regulatory meetings, and major sections of regulatory filings.
  • Use state of the art modeling and simulation approaches to interpret PK/PD data and to integrate PK, PD, safety, and efficacy data to ensure appropriate dose and schedule decisions.
  • Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, exposure-response analysis etc.

Qualifications and Experience

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline.  Equivalent combination of education and applicable experience may be considered.
  • Minimum 6 years of relevant Clinical Pharmacology experience is required.
  • Hands-on experience with at least 2 modeling and simulation software (e.g., Phoenix WinNonlin, NONMEM, Berkeley Madonna, R, S-Plus, SimCYP, and GastroPlus) is strongly preferred.
  • Prior regulatory interactions and working experience in the preparation of regulatory documents and filings are highly desired.
  • Demonstrates a breadth of diverse leadership experiences and capabilities, including the abilities to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Excellent interpersonal and collaborative skills, with a professional demeanor and the ability to interact with all levels of management, colleagues and external collaborators.
  • Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.
  • Ability to manage multiple, complex tasks with competing timelines.
  • Self-motivated and can independently manage responsibilities.
  • Ability to travel (<10%).


Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth.  We regularly benchmark our compensation against leading biotechnology companies in our geographies.  


Our team enjoys: 

  • Industry leading vacation and paid time off
  • Excellent health and wellness benefits
  • Zymelife health and wellness benefits
  • Paid time off to volunteer in your community
  • Matching RRSP / 401K program
  • Employee Share Purchase Program
  • Employee Equity Program


All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability. 


NOTE TO AGENCIES:  Zymeworks values our relationships with our recruiting partners.  We only accept resumes from those partners who have been contracted with us.  Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.  

Date:  Mar 9, 2023