Chinook Therapeutics Job Description: Clinical Project Manager
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. Our lead program, atrasentan, is a late-stage clinical program for the treatment of primary glomerular kidney diseases planned to move into a phase 3 trial for IgA nephropathy in early 2021. We are also advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease. In addition, our pipeline has several other internal programs at the validation and lead optimization stages and we are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook raised a $65 million Series A financing in 2019 from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital, and recently announced a proposed merger with Aduro Biotech, Inc., which we expect to close in the second half of 2020. Chinook will be the surviving company following the merger and will trade on Nasdaq. Chinook currently has approximately 45 employees and is based in Seattle, Washington and Vancouver, British Columbia.
Chinook has an exciting opportunity for an experienced Clinical Project Manager who will support planning and execution of clinical trials with a primary focus on facilitation of cross-functional activities, establishment and maintenance of project milestones, timelines, and trial related forecasts. This position reports to the Director, Clinical Operations and is based in Chinook’s Seattle location.
- Champion study priorities and healthy team dynamics
- Facilitate cross-functional study teams in the timely delivery of clinical trials
- Assist in development of study design, documents, and plans (e.g., protocol, IB, CSR, etc.). Track and help drive development to completion
- Support development of comprehensive study budgets in partnership with CTM and other functions as relevant and help the team manage costs to established budgets
- Develop study-related forecasts (e.g., enrollment, drug supply, spend, team performance, etc.)
- Establish and maintain comprehensive timelines for each study, and uses these timelines to help drive study team activities
- Initiate and facilitate RFI, RFP, and other vendor management and oversight activities
- Contribute to development and implementation of various cross-functional study plans and materials (e.g., CRO oversight plans, vendor oversight plans, communication plans, data management plans, safety management plans, IND safety report distribution, etc.)
- Facilitate ongoing risk management activities
- Facilitate cross-functional team meetings and vendor meetings
- Establish and review Key Performance Indicators /metrics for performance and quality
- Negotiate and manage competing priorities across functions to ensure on time, within spec delivery
- Manage, coordinate, and oversee vendors involved in the clinical study, e.g. central lab, CROs
- Prepare reports (financial, project, etc.) for management on program status
- Ensure study activities are conducted in compliance with applicable regulations
- Actively learn and increase understanding and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions
- Contribute to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- Bachelor's degree or equivalent, preferably in a health, science, finance, or business-related field
- At least 8 years prior work experience with at least 2 years experience as a project coordinator or project manager, preferably in a biotech, pharmaceutical, health, science, finance, or business-related field.
- Project management training and knowledge of project management methodologies and tools
- Experience forecasting and managing project budgets preferred
- Vendor contracting and management experience
- Knowledge and understanding of research regulatory guidelines and policies, i.e., GCP/ICH, the Code of Federal Regulations as well as other global regulations
- Highly effective written/verbal communication skills
- Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote
- Demonstrated Proficiency with either SmartSheet or MS project and has experience developing comprehensive study/project timelines (e.g., study concept through CSR)
- Willingness and ability to travel globally up to 30%
- Demonstrated strategic and tactical abilities
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.