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Chinook Therapeutics

Sr. Clinical Project Manager

Clinical · Seattle, Washington
Department Clinical
Employment Type Full-Time
Minimum Experience Experienced

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.  Our development focus is on rare, serious disorders with clear unmet medical needs and with defined and rapid clinical development opportunities.  Chinook recently in-licensed a late-stage product from large pharma, and plans to initiate a phase 3 trial for chronic kidney disease during 2020.   Our pipeline  has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021.  We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.

Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital.  We are a growing team of approximately 25 employees and are based in Vancouver, British Columbia and Seattle, Washington.


Position:
 

Reporting to the Head of Clinical Development Operations, the Sr. Clinical Project Manager will be responsible for the overall planning, initiation, completion, and reporting of clinical trials. The Sr. Clinical Project Manager will be responsible for leading cross-functional teams to meet clinical project milestones and objectives consistent with the Clinical Development Plan. 


Responsibilities include:
 

• Integrated, cross-functional planning and execution of clinical trials to ensure quality deliverables are met on time and within budget.

• Support team members to ensure study deliverables are clearly established and met. 

• Forecast and monitor project timelines, cost, and clinical supply inventory.

• Support development of project plans.  

• Lead the evaluation, selection, contracting, and management of CROs and third-party service providers to ensure successful clinical trial execution.

• Support development of clinical study protocols, informed consent forms, and other clinical documents.

• Establish and track appropriate performance metrics for trends.

• Report study metrics and project status to leadership.

• Perform proactive risk identification, management, and escalation.

• Ensure clinical trials are carried out according to the study protocol, SOPs, ICH/GCP and any study-specific guidelines. 

• Facilitate study team meetings and vendor meetings.

• Manage internal communication and serve as a liaison and resource for third-party service providers. 

• Support the establishment of a high-performing Clinical Development Operations Department focussed on innovation and excellence.

• Guide and manage both internal and external talent to execute on clinical study deliverables.


Education, Experience, and Skills:

• Bachelor’s degree in Life Sciences or related discipline.

• 8+ years progressive clinical operations experience in the pharmaceutical/biotech industry.

• Experience managing Phase I-III clinical trials. 

• Experience managing CROs and other third-party vendors.

• Knowledge of CFR and GCP/ICH requirements. 

• Proven leadership success supporting teams to collaborate and excel.  

• Excellent communication skills and organizational skills. 

• Strong interpersonal skills with the ability to work collaboratively as a member of a cross-functional team, with CRO personnel, and with investigative site staff. 

• Project management training and knowledge of project management methodologies and tools.

• Experience managing direct reports is preferred.

• Consideration given to candidates with therapeutic experience in kidney disease. 

 

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.

 

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  • Location
    Seattle, Washington
  • Department
    Clinical
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced