Associate Director, Data Management

CMC (700) · Seattle, Washington
Department CMC (700)
Employment Type Full-Time
Minimum Experience Experienced

Chinook Therapeutics Job Description: 

Associate Director, Clinical Data Management

 

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 Associate Director, Clinical Data Management (A.D. CDM) will be responsible for operational execution of CDM responsibilities for clinical trial programs including but not limited to the oversight of data management activities including Case Report Form (CRF) design, database design, developing Data Management Plan, implementing edit check programs, data entry and query status tracking, and database closure. This role is responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in routine and ad hoc meetings. This role will work collaboratively with biostatistics, clinical, safety, regulatory groups and CROs, as needed, on global clinical trials.  

 

 Responsibilities include:

  • Provide data management leadership, insight, and support to all internal and external Chinook projects and clinical trials
  • Supports study teams by providing standards for data capture and safety data, assessing the overall quality of data and identifying and escalating key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
  • Manage and provide oversight of data management personnel and activities of CROs and vendors
  • Provide expertise in the development of CRF/eCRF for clinical trials and its impact into database design/development.
  • Assemble data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.)
  • Confirm adherence to defined standards, and responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness
  • Enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
  • Identify new data standards, technologies, and systems and ensure proper implementation
  • Develop SOPs to support data management activities
  • Provide technical oversight of contracts supporting clinical trial activities
  • Provide project management expertise to ensure quality and timely completion of project milestones
  • Participate in Clinical Project Teams and support regulatory submission activities
  • Contribute to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

  • Bachelor’s degree or higher
  • Minimum of 10 years experience in leading and supporting data management activities in clinical research for all phases of clinical trials, supporting global trials.
  • Experience in managing and leading DM Staff.
  • Knowledge and experience with various clinical databases and key technologies (e.g., EDC, eCOA, CTMS, IRT)
  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements.
  • Strong working knowledge of and experience with CDISC standards including SDTM and AdAM dataset specifications and Define-XML.
  • Proven experience with system design and implementation.
  • Ability to analyze information, review reports, communicate outcomes, and prioritize actions.
  • Excellent computer skills; strong verbal and written communication skills. 
  • Ability to work well in a team environment both as a contributor and leader
  • Self-sufficient and able to work with minimal oversight.
  • Proficiency in Microsoft Office applications.
  • Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships
  • Positive attitude and high personal and ethical standards in achieving corporate goals

 

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
    Experienced