Scientist (Sr), Clinical Pharmacokinetics

Clinical Pharmacology Vancouver, BC Canada


Description

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.

Company Description

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 professional who is looking to grow their career with our company.  

This position will report to the Senior Director, Clinical Pharmacology and can be Remote (Canada) or based in our offices in Vancouver, BC.  

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

About the Position 
The Scientist (Senior) will be responsible for understanding the pharmacokinetics (PK) of clinical-stage therapeutics during all 3 phases of Clinical Development. The qualified candidate will work closely in the design, conduct, analysis, interpretation and reporting of clinical PK, ADA and NAb studies in a fast paced and dynamic environment. Responsibilities of this position include extensive interaction and communication with multiple vendors (Contract Research Organizations) across the world as well as internal clinical project team leads in Data Management, Clinical Operations, Biomarkers, Biometrics and Modelling and Simulations.


Key Responsibilities 

  • Independently designs, direct, interprets and reports bioanalytical method development, validation and sample analysis using immunoassays (ELISA, MSD and IP/MS).
  • Provides guidance to troubleshoot assay-related problems and suggests follow-up experiments. Suggests modifications to protocols or alternative methods.
  • Writes relevant sections of clinical documents such as study protocols, IBs, CSRs and contributes to the development of DTAs, SAPs, SAOs and TLFs, in addition to regulatory documents. 
  • Reviews and approves method validation plans, validation reports and bioanalyltical reports.
  • Completes PK, ADA and NAb study reports and maintains adequate records in compliance with regulatory guidelines.
  • Summarizes and presents results to supervisor in a logical manner, verbally and in written reports or presentations. May present data to project team meetings.
  • May evaluate new technologies for the development of immunoassays using new formats or techniques.
  • Sets timelines for all clinical PK/ADA/NAb studies and collaborates with CROs and other clinical team members for prompt execution of timelines.
  • Works closely with SAS programmer and sample custodian to ensure deliverables are completed in a time-efficient manner. 

Qualifications and Experience 

  • PhD or equivalent in Biotechnology/Pharmacology/Biochemistry or related scientific discipline with a minimum 3-5 years of relevant experience within a pharmaceutical industry, contract research, or clinical research.
  • Proven ability to direct clinical work performed at CROs.
  • Experience developing and validating clinical PK, ADA and NAb assays is preferred.
  • Experience performing noncompartmental analysis in Phoenix Winnonlin is a must for this position
  • Experience writing PK/Immunogenicity sections of clinical and regulatory documents.
  • Advanced spreadsheet skills are desirable.
  • Exceptional analytical and problem-solving capabilities. 
  • Effective written and verbal communication skills. 
  • Ability to manage multiple projects, prioritize work, and meet deadlines.
  • Capable of anticipating and recognizing potential problems within project plans and effectively communicate alternatives.   
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. 

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.

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