Senior Clinical Trial Manager:
Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapies with novel mechanisms of action in key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and well-defined clinical development opportunities. Our lead program, atrasentan, is a potent and selective, small molecule inhibitor of the endothelin A receptor that is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, in 2021. We are advancing BION-1301, an anti-APRIL monoclonal antibody, in an ongoing phase 1b trial for IgA nephropathy, and CHK-336, an oral small molecule LDHA inhibitor for primary hyperoxaluria, towards trial initiation in 2021. Our pipeline also includes several additional preclinical programs at the validation and lead optimization stages, and we continue to actively evaluate business development opportunities around early and late-stage clinical assets in kidney disease.
Chinook completed the third quarter of 2020 with over $290 million in operating capital and trades on Nasdaq under the ticker symbol, “KDNY.” The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.
The Senior Clinical Trial Manager (CTM) is a key member of the Clinical Operations Team, supporting the successful execution of clinical trials. The Senior 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 Operations in the Berkeley, CA office.
- Manage Phase 1-3 local and or global clinical trials. May serve as Study Lead for more than one trial
- Ability to draft an RFP and review vendor proposals and budgets
- Review Invoices and track study budget according to projections
- Contribute to BID Defense Meetings and vendor selection
- Manage multiple study vendors including, CROs, IRT and central laboratories with oversite of activities
- Partner with investigative site personnel 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
- Collaborate with Clinical Scientist/Medical Director on development of Site Initiation Visit slides
- Contribute to the development and maintenance of study plans and documents, including but not limited to the following: Study Start-up Plans, Clinical Monitoring Plans, Pharmacy Binder, Safety Monitoring Plan, Recruitment Plan, Investigative Site File Binder
- Contribute to development of study timelines and key milestone activities
- Contribute to site and enrollment projections vs actuals
- Collaborate with CMC on investigational product to support study needs
- Review and approve vendor invoices and track financials
- Assist with data cleaning activities
- Partner with Translational Medicine to oversee research specimen collection, including accountability, monitoring, reconciliation, and shipments to reference labs as needed. Utilize central laboratory portal to track specimen results and disposition
- Facilitate information flow between clinical trial sites, internal study team members, CROs, and vendors.
- 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 be responsible for dotted-line management of team members
- Escalate study issues/risks in a timely manner with solid communication skills
Education, Experience, and Skills:
- 8 years of relevant clinical trial management experience
- BA/BS in a science related degree
- Experience managing and overseeing activities performed by CROs is required
- Ability and willingness to travel is required (domestic and internationally)
- Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as additional regulatory requirements based upon study need is necessary
- Strong cross functional 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.