Senior Project Manager, CMC

CMC (700) · Seattle, Washington
Department CMC (700)
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 therapeutics with novel mechanisms of action against key kidney disease pathways. Our 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 diseases, which is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, both in early 2021. We are also evaluating BION-1301, an anti-APRIL monoclonal antibody, in a phase 1b trial for IgA nephropathy, and are advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease.  In addition, our pipeline has several other preclinical 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 launched in 2019 with a $65 million Series A financing from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital.  In October 2020, we merged with Aduro Biotech, Inc. and completed a $115 million financing with leading healthcare investors, including EcoR1, Orbimed and others.  Chinook now has over $275 million in operating capital and trades on Nasdaq under the ticker “KDNY”.  The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.

 

Position:

 

The Senior Project Manager is a crucial role in the CMC group.  The Sr. Project Manager has an overall understanding of CMC function, with responsibility for managing key activities across CMC disciplines. The successful candidate will work with internal project teams covering early to late stage development, registration, and commercialization, and external partners including CMOs and CROs. This position is preferably based out of Chinook's Seattle location, but for the right candidate, we may consider other locations.


Responsibilities Include:

 

  • Coordinate and synchronize CMC activities and team meetings with CMOs or other external partners by planning meeting agendas, providing minutes, and ensuring milestones and action items are assigned, tracked, and completed.
  • Develop and manage integrated CMC timelines for contract manufacturing partners (CMOs), and internal teams for clinical product development, analytical development, drug substance and drug product manufacturing and release of clinical batches.
  • Manage CMC-related activities including but not limited to regulatory filings, budget tracking, quarterly accruals, long range planning, purchase request, invoices, contracts, agreements, and meeting scheduling.
  • Work closely with Chinook program management group, project, and launch teams and insure seamless communication throughout the organization.
  • Contribute to and assist with establishing master contracts and work orders for CMC activity and serve as departmental point of contact for securing internal review and approvals.
  • Develop and apply best practices in the planning, initiation, execution, and closing of projects.
  • Provide leadership in project tracking by developing and providing consistent best practices and project reporting to CMC leadership and project teams.
  • Anticipate issues and lead risk assessment processes and review of mitigation plans across projects and programs. Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances, or the overall business relationship.
  • Optimize information distribution and communication to cross-functional study teams.
  • Ensure alignment with cross functional team project managers. Provide clear directions to meet expectations of all stakeholders.

 

Education, Experience, and Skills:

 

  • Bachelor’s degree or equivalent with 7 years in a life sciences discipline or engineering. Prefer 5 years project management experience within the pharmaceutical industry, with emphasis on pharmaceutical sciences, CMC, product development, related regulatory requirements, and supply chain management.
  • This position requires a broad-based CMC specialist, ideally with experience working in a highly outsourced operating environment.
  • Experience managing external relationships with CMO and CRO partners, central laboratories including RFP processes, budgeting, and supply chain coordination. Ideally, experience will span all stages of development, registration, and commercialization.
  • Outstanding interpersonal skills and excellent oral and written communication skills including attention to detail and ability to adapt to evolving priorities.
  • Demonstrated critical thinking skills, decision making and problem-solving skills, coupled with the ability to operate autonomously under general direction.
  • Outstanding organizational skills. Strong initiative and desire to work in a fast paced, team oriented dynamic environment and able to reinforce Chinook Culture and improve processes where needed.
  • Proficiency in Microsoft Office suite and other project management tools.

 

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
    CMC (700)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor