Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
- Provides medical/scientific, strategic and operational expertise and support into the planning and execution of medical support activities including Phase I trials with IND filings, progressing into Phase II and later stage trials.
- Develops functional plans for managing clinical research activities, including activities performed through third-party relationships to complete clinical trials.
- Provides expert opinion and pathophysiology, diagnosis, existing and emerging treatment options and unmet medical needs to inform key medical and business decisions.
- Manages the Medical Writing group. Monitors performance, encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge. Leads through example to establish an environment fostering effective and collaborative working relationships.
- Oversees clinical research activities including data management strategies and systems development of required reports and regulatory filings to gain product approval.
- Conducts medical monitoring of clinical development programs including, involvement in authoring 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, oversight of conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH), standard of care evaluation, training 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.
- Remains informed of current therapeutic area specific developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations.
Qualifications and Experience
- MD or MSc., with experience in the area of oncology, autoimmune and inflammatory diseases and a minimum of 10 years of progressive experience in the biotech or pharmaceutical industry or an equivalent combination of education and experience.
- 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 with the proven ability to manage, develop and empower employees.
- 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 and effectively respond to data queries from customers and/or consultants.
- Ability to travel.
- Proficiency with MS Office and knowledge of database management Veeva Vault, an asset.
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 http://www.zymeworks.com/.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please forward your cover letter and resume to email@example.com.