Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
This position will report to the Vice President of Clinical Research and will be based in Seattle, WA or Vancouver, BC.
- Provides medical/scientific, strategic and operational expertise and support for the planning and execution of IND filings, Phase I trials, Phase II and later stage trials.
- Provides expert opinion on the pathophysiology, diagnosis, existing and emerging treatment options and unmet medical needs to inform key medical and business decisions.
- Conducts medical monitoring of clinical development programs; writes protocols, investigator brochures, informed consent documents; responses to questions from regulatory agencies, institutional review boards and ethics committees and study reports; reviews clinical data, case report forms and ensures final accuracy of clinical trial data.
- Conducts safety monitoring, oversees conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH), standard of care evaluation; trains investigators and travel to clinical sites to build relationships with investigators and study teams in support of study enrollment.
- Institutes and continuously improves operating procedures ensuring best practices.
- Establishes appropriate strategic partnerships with centres of excellence, advocacy groups and KOLs in the areas of scientific interest.
- Collaborates closely with key stakeholders to ensure tight strategic integration of product development plans and strategies. Plans and develops content for advisory meetings with opinion leaders and medical symposia.
- Participates in review of promotional and medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
- Keeps up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions and professional associations.
Qualifications and Experience
MD or MSc., with experience in the area of oncology, autoimmune or inflammatory disease and a minimum of 3 to 5 years of progressive experience in the biotech or pharmaceutical industry or an equivalent combination of post-fellowship training experience.
Skills and Abilities
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
- Strong leadership skills and the ability to lead through example.
- Experience in or knowledge about drug-development procedures. Industry/academic experience in planning, executing and reporting clinical trials is preferred.
- Strong understanding of clinical trials process with demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives.
- Early stage development and regulatory experience preferable.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong problem-solving skills and the ability to think and act strategically, anticipate road-blocks and map out next steps.
- Demonstrated high level of integrity, ethics and professionalism.
- Knowledge of scientific methods, research design and medical practices and procedures.
- Excellent written, oral and presentation skills. Demonstrated ability to communicate scientific results.
- Ability to travel.
Why Work for Us?
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. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.