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Chinook Therapeutics

Sr. Clinical Trial 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 Trial Manager will be responsible for planning and execution of clinical trials at investigative study sites across the globe. The Sr. Clinical Trial Manager will provide key support to investigative sites and quality oversight of site management and monitoring activities in both early and late stage clinical trials.


Responsibilities include:

• Lead the evaluation, selection and management of investigative sites to ensure successful clinical trial execution.

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

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

• Develop site and patient-facing material.

• Develop global, regional, and site-specific recruitment plans to ensure timely completion of study enrollment.

• Review monitoring reports and metrics for quality oversight and to monitor site trends. 

• Support data review and cleaning to ensure compliance and data integrity. 

• Plan and participate in site initiation visits, study meetings, and vendor meetings.

• Assist in the preparation and follow-up of quality audits and regulatory authority inspections.

• Manage site related interactions and serves as a liaison and resource for investigational sites. 

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

• Guide and develop talent and resources.

 

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. Global Phase III experience preferred. 

• Thorough knowledge of CFR and GCP/ICH requirements. 

• Excellent communication skills, organizational skills, and exceptional attention to detail. 

• Solutions-focused and able to work in a dynamic start-up environment.

• Proficiency with clinical systems such as CTMS, EDC and eTMF. 

• 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. 

• 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