Vice President, Clinical Operations

Seattle, United States

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary: Undisclosed

Position Type: Full Time

Job 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.

About the Position

This leadership position is accountable for resourcing, development, training and management of a high performing clinical operations team. The position will provide strategic direction for, and executive oversight of, operational matters impacting Zymeworks’ clinical development programs, including trial planning, study and protocol design and development, execution within budget and timelines, and quality and compliance.

This position will report to the Chief Medical Officer.

Key Responsibilities

• Develop strategy and oversee implementation of activities for clinical operations to support all development activities for pre-clinical, clinical and marketed products.
• Provide strategic and operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs.
• Lead the establishment, implementation and management of clinical trial processes, strategic outsourcing and performance indicators.
• Drive the performance, operational quality, innovative development strategies/trial designs, and the timely contributions of operations support to commercial and medical
• Partner with medical, regulatory, CMC, program management, and other functions to provide oversight and leadership that supports and ensures execution of programs that enable data generation of integrity and quality to support market claims, successful market access and generate valuable data for medical communication.
• Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; accountable for maintaining pro-active approach to inspection readiness
• Oversee and troubleshoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with direct reports/functional leads.
• Oversee relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget.
• Contribute to business development activities providing clinical expertise and strategic operational considerations.
• Ensure GCO representation as needed in governance or strategic teams or committees.
• Lead and/or mentor the clinical project management, clinical documentation, clinical supply and clinical compliance functions to ensure successful internal trainings are conducted, and project and organization goals are met. Serve as an advocate for professional development of Clinical Operations staff.
• Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.

Qualifications and Education

• Masters or Doctorate degree in a life-sciences discipline and minimum of 15 years progressive experience in clinical drug/device development, including global oversight of operations for oncology registrational programs and minimum 10 years managing Clinical Operations.
• Experience in inflammatory or autoimmune disease preferred.
• Domestic and international clinical trial execution experience required (must include global registrational trials, and experience managing multiple concurrent programs).
• Post-approval clinical management experience a plus.
• Direct management experience over clinically related functions and experience working in a dynamic environment with other functional groups (e.g. Regulatory, Medical Writing, Med Affairs, Commercial).
• In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to successfully manage early phase clinical programs up through regulatory filing
• Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities.
• Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and/or organization goals.
• Analytical thinker with excellent problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to travel domestically and internationally up to 30 percent.

Why work for us?

Innovation. Act with Integrity. Collaboration. 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.

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary($): Undisclosed

Position Type: Full Time

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