Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. Chinook recently in-licensed a late-stage product, atrasentan, and plans to initiate a phase 3 trial for chronic kidney disease in early 2021. Our pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021. We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital. We are a growing team of approximately 40 employees and are based in Vancouver, British Columbia and Seattle, Washington.
The Director, Data Management will be responsible for the planning, implementation and overall direction of clinical trial data management activities to achieve high quality databases, in a timely manner, to support drug development processes and global submissions. The role will be responsible for oversight of external business partners, including technology vendors and CROs, and management of external electronic data sources in order to support drug development processes and global submissions. The Director, Data Management will be based in the Seattle, Washington office and will report to the Head of Biometrics.
- Provide data management leadership, insight, and support to all internal and external Chinook projects and clinical trials
- Manage and provide oversight of data management personnel and activities of CROs and vendors
- Oversee, review, and approve all data management documentation
- Provide expertise in the development of CRF/eCRF for clinical trials and its impact into database design/development
- Assemble data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.)
- Confirm adherence to defined standards, and responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness
- Enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance
- Identify new data standards, technologies, and systems and ensure proper implementation
- Develop SOPs to support data management and biometrics activities
- Provide technical oversight of contracts supporting clinical trial activities
- Manage biometrics deliverables from CROs
- Provide project management expertise to ensure quality and timely completion of project milestones
- Participate in clinical project teams and support regulatory submission activities
- Contribute to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- Bachelor’s degree or higher with a minimum of 15 years directly related experience including leading data management activities in clinical research for all phases of global clinical trials
- Knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements
- Extensive knowledge of and experience with CDISC standards including SDTM and AdAM dataset specifications and Define-XML
- Proven experience with system design and implementation
- Ability to analyze information, review reports, communicate outcomes, and prioritize actions
- Excellent computer skills; strong verbal and written communication skills
- Ability to work well in a team environment both as a contributor and leader
- Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships
- Positive attitude and high personal and ethical standards in achieving corporate goals
Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.