Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.
Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.
The Clinical Trial Manager (CTM) is a key member of the Clinical Operations Team, supporting the successful execution of clinical trials. The CTM has primary responsibility for implementing studies across clinical trial sites and quality oversight of site management and monitoring activities across both early and late stage clinical trials. This position reports to the Director of Clinical Trial Management.
- Support clinical trial management efforts on global, late-stage clinical trials and/or serve as lead CTM on early phase clinical trials.
- Partner with investigative site personnel, CROs, and other study vendors to drive key study activities.
- Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites.
- Contribute to the design and review of clinical trial protocols, CRFs, and Clinical Study Reports in collaboration with cross-functional study team members.
- Develop informed consent forms and other patient-facing materials.
- Contribute to the development and maintenance of study plans and documents, including but not limited to Study Start-up Plans, Clinical Monitoring Plans, Site Instructions, Forms, and Binders.
- Contribute to development of study timelines and milestone setting.
- Contribute to study forecasting and tracking of enrollment, investigational drug, and financials.
- Perform data cleaning activities.
- Oversee relevant CRO and/or vendor activities.
- Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
- Facilitate information flow between clinical trial sites, study team members, CRO’s, and vendors.
- Ensure completeness of Trial Master File (TMF) and various tracking systems for assigned studies.
- Participate in the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.
- May train and mentor new clinical staff and may contribute to dotted-line management of team members.
Education, Experience, and Skills:
- 8 years of relevant clinical trial management experience
- BA/BS or equivalent
- Experience managing and overseeing CROs is strongly preferred
- Ability and willingness to travel is required (domestic and internationally)
- Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required
- Strong leadership, communication, and organization skills
- Exceptional ability to plan, organize and conduct clinical studies with minimum oversight
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)
- Consideration given to candidates with therapeutic experience in kidney disease
Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We respect and value different experiences and viewpoints. We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.