Zymeworks

Senior Clinical Scientist

Clinical Research - Canada

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. The Senior Clinical Scientist has the primary responsibility for supporting the scientific integrity of clinical program and clinical trials including sponsor oversight of trial site protocol compliance.

This position will report to the Medical Director or Senior Medical Director and will be based in Vancouver, BC or Seattle, WA.

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

Key Responsibilities

• Maintain a thorough understanding of assigned programs, protocols, and protocol requirements.
• Study Design and Clinical Document Development.
• Give scientific input to program strategy and protocol design.
• Contribute to authorship of Study Protocols, ICF, Clinical Study Reports, Statistical Analysis Plans, Investigator Brochures, DSUR, Briefing Books, Health Authority Communications, Labels, etc.
• Develop Clinical Narrative plan and reviews clinical narratives.
• Contribute to database build and authorship of clinical report form completion guidelines.
• Training
• Educate study team members on protocol and protocol requirements.
• Provide training to sites and CRAs on protocol and protocol requirements and serves as primary contact for clinical questions.
• Study Conduct
• Plan and lead implementation of study startup/conduct/close-out activities in collaboration with CTM as applicable.
• Provide input to vendor SOW, contract, charter development.
• Assist with vendor management to ensure scientific integrity of the services they provide.
• Organize Trial Committees (SC, DMC, BICR, etc.).
• Data Review
• Review clinical data, including protocol deviations, to ensure accuracy of clinical database with an emphasis on scientific integrity.
• Identify trends in clinical data, provide trends and escalate medical questions to the Medical Monitor.
• Review of MedDRA and WHODRUG coding.
• Evaluation of safety, pharmacology, and efficacy data at a program level.
• Represent Clinical Research at study team meetings or other meeting venues as needed.
• Contribute to and review Clinical Research SOPs, Work Instructions, and Job Aids.
• Collaborate and serve as a primary liaison between external partners for scientific advice.
• Prepare manuscripts, abstracts, and presentations for scientific meetings Train and mentor Junior Staff.
• Other duties may be assigned.

Qualifications and Education

• Advanced Life Science and/or Medical Degree (RN, ARNP, PharmD, Physician Assistant, PhD, MD, or equivalent.).
• A minimum of 5 years relevant clinical experience in the biopharmaceutical industry or equivalent setting preferred.
• Proficient knowledge of ICH/GCP, drug development process, study designs, statistics, clinical operations.
• Proficient knowledge of oncology, KOLs, indications, compounds, preferred.
• Understanding of functional and cross-functional relationships.
• Ability to assimilate technical information quickly.
• Strong analytical, assessment and problem-solving skills.
• Demonstrated ability to read, analyze and interpret clinical data and information.
• Proficiency in Medical Terminology. Excellent verbal, written, communication and interpersonal skills.
• An ability to work collaboratively as a member of a cross-functional team.
• Outstanding attention to detail, organizational skills and a commitment to accuracy.
• Ability to manage and prioritize multiple activities and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
• Proficiency with Microsoft Office Suite.
• 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.

How to Apply

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.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 06/18/2022