Associate Director, Clinical Project Management

Clinical Ops (600) · Seattle, Washington
Department Clinical Ops (600)
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Company:

 

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.

 

Position:

 

The Associate Director, Clinical Project Management will contribute to the strategic development of the function to ensure the CPM team delivers high-quality, on-spec clinical trials. As a facilitative leader who partners across functions and vendors to optimize and drive the planning and execution of clinical trials, the AD CPM will be responsible for one or more clinical trials and serve as role model and mentor to junior staff in establishing and maintaining project milestones, integrated study timelines, forecasts, and ongoing risk management. This position reports to the Director, Clinical Operations or above and is based in Chinook’s Seattle location.

 

 Responsibilities include:

 

  • Help establish and continuously cultivate the CPM function, building and maintaining a fit-for-purpose infrastructure
  • Grow the CPM team commensurate with the portfolio and infrastructure needs
  • Collaborate with Program Management to ensure alignment of program and studies
  • Contribute to the development of project, program, and department goals, and implement strategies to meet those goals
  • Develop and aggregate content to optimize communications between study team, program team, and Chinook leadership, including our Board of Directors, conveying study status, risks and mitigations, and escalating issues as relevant, etc.
  • Initiate and lead process improvement initiatives, developing and maintaining CPM best practices and ensuring consistency of implementation across studies
  • Identify and assign CPM resources to ensure clinical trial success
  • Ensure high-quality monthly reporting and dashboards
  • Guide the team to ensure ongoing project lessons learned, change management, re-forecasting, budget variance tracking, and trial execution are consistently well managed
  • Lead periodic review of project management plans, project overviews, timelines and risk assessments across the portfolio
  • May serve as CPM for one or more studies, championing study priorities and healthy team dynamics:
    • Enable: using project management methodology and tools, optimize study execution in collaboration with individual team members as well as the whole
    • Shepherd: as a catalyst responsible for driving the project forward, model and create a respectful space for all study team members to do their best work, motivating the team through recognition of their contributions, inspiring them through shared vision and common goals, and demonstrating courage by having timely and sometimes difficult conversations as needed for the sake of the team and the project
    • Harmonize: provide continuity to the team via unified perspective garnered from deep cross-functional collaborations; manage barriers to the on-spec delivery of the trial, balancing priorities, risks, and opportunities, cost, quality, and time
    • Communicate: ensure all study team members have a clear sense of direction and priorities; listen to hear each team member, offering a lens through which continuity of information may be understood and shared.  Ensure the right information reaches the right people at the right time
    • Champion: empower team members to share their perspectives and ideas, make recommendations and make decisions.  Help remove roadblocks.
  • May manage and develop direct reports as well as supporting the development of other Clinical Development Operations staff

 

Education, Experience, and Skills:

 

  • Bachelor's degree or equivalent, preferably in a health, science, finance, or business-related field and at least 12 years experience with at least 6 years as a project manager, preferably in a biotech or pharmaceutical field; or a master’s degree with at least 8 years prior experience; or a PhD with at least 5 years experience
  • Project management training and knowledge of project management methodologies and experience wielding project management tools
  • Experience forecasting and managing multi-million-dollar project budgets
  • 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
  • Ability to set expectations and hold individuals and teams accountable
  • Detail focused and organized with an understanding that communication and transparency are critical to achieving success 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)
  • Willing and able to travel globally up to 30%
  • Demonstrated strategic and tactical abilities
  • Experience with alliance management preferred
  • 2 years supervisory experience preferred

 

 

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.

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  • Location
    Seattle, Washington
  • Department
    Clinical Ops (600)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor