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Chinook Therapeutics

Head of Regulatory Affairs and Quality Assurance

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. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities.  Chinook’s pipeline currently has several internal programs at the validation and lead optimization stages rapidly progressing for multiple programs 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.

Role:

In anticipation of a potential initiation of a late-stage clinical program for Chinook’s growing pipeline, we have a new opportunity for a Head of Regulatory Affairs and Quality Assurance, responsible for leading all aspects of regulatory and quality strategy and implementation across Chinook’s pipeline from discovery through to global approvals and commercialization. This role will serve as the primary point of contact representing the company to global regulatory agencies, manage content and operational aspects for all regulatory submissions, and oversee quality management across R&D, CMC, and ultimately Commercial functions. The position will be based in Seattle, Washington or Vancouver, BC, report to the Chief Medical Officer, and be a key member of the development leadership team.

Responsibilities include:

  • Building and leading the Regulatory Affairs function in the development and implementation of regulatory strategies and processes to gain global product approvals
  • Building and leading the Quality Assurance function and ensuring appropriate quality systems and standard operating procedures are in place to support manufacturing, development, and commercialization
  • Providing guidance and education to the organization on the impact of regulatory and quality issues on overall corporate strategy
  • Serving as the primary point of contact for global regulatory authorities, regulatory inspections, and overseeing the company’s vendor/site audit plans
  • Ensuring the company is in full compliance with global regulatory requirements and all applicable standards
  • Managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.), including the oversight of vendor activities and budgets
  • Overseeing the review and approval for product packaging and labeling, and when appropriate participating in approval of advertising and promotional materials and activities
  • Coordinating quality investigations, root cause analyses, risk assessments and implementation of change control, and corrective and preventive actions, as appropriate
  • Partnering with the executive leadership team on presentations to the Board of Directors, investors, potential corporate collaborators and all other external constituents
  • Contributing to the development and maintenance of a positive team-focused company culture 

Education, Experience, and Skills:

  • Minimum of BA/BS in a scientific discipline with at least 15 years of pharmaceutical and/or biotechnology industry experience – regulatory affairs certification (RAC), auditor certification (CQA), and/or graduate work in life sciences/engineering preferred
  • Strong leadership skills and proven ability to translate corporate objectives into effective regulatory and quality action plans
  • Experience leading global regulatory and quality organizations through critical product milestones, preferably with some experience in rare disease development involving novel regulatory strategies and approval pathways
  • Experience with all phases of product development, including complex international late stage development programs and global approvals
  • Extensive hands-on experience in the development of key regulatory submissions including NDAs, BLAs, MAAs, and INDs as well as interacting with regulatory authorities and supporting site/sponsor regulatory inspections
  • Experience building quality systems, training systems and associated infrastructure to support compliance in a growing development organization
  • Outstanding leadership abilities with a track record of recruiting, developing, retaining, and motivating high performing teams
  • Thorough understanding of GCP and ICH Guidelines governing the conduct of clinical trials, applicable sections of the Code of Federal Regulations, and GMP requirements
  • Solution-oriented team player with executive presence and demeanor, excellent written and verbal communication skills, and outstanding analytical abilities
  • Ability to adapt quickly to changing environments and priorities
  • Positive attitude and high personal and ethical standards in achieving corporate goals 

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 basis of 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
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