Sr. Director, Regulatory Affairs CMC

Company:

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook's product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook's lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.

Position:

The Sr. Director Regulatory Affairs CMC will provide oversight for global development, implementation, and execution of regulatory CMC strategies for investigational programs, through to and eventually beyond marketing applications. They will be integral in developing the standards for the Regulatory Affairs CMC function within Chinook. This role will report into the SVP, Regulatory Affairs and can be based in one of our office locations or remote within the United States.

Responsibilities include:

• Develop strategic CMC leadership in all stages of development
• Lead the CMC Regulatory Affairs CMC activities in line with US, European, and other applicable regulations globally
• Build processes and standards to establish the Regulatory Affairs CMC practices within Chinook
• Develop CMC strategy in partnership with CMC/Technical Operations and Quality functions
• Assess impact of CMC changes on global clinical trial and marketing applications
• Represent Regulatory Affairs CMC function for internal and external collaborations
• Manage the preparation, review and submission of documentation to regulatory authorities
• Maintain compliance with all applicable requirements
• Lead interactions with US and international health authorities regarding CMC topics
• Participate in ongoing assessment of relevant CMC changes in regulatory environment as applicable to Chinook products
• Contribute to the development and maintenance of a positive team-focused company culture

Education, Experience, and Skills:

• Minimum of a BS/BA in life science of related scientific discipline
• At least 10 years of regulatory CMC experience
• Expert working knowledge of FDA, EMA, and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory submissions
• Prior large molecule/biologics development through NDA/MAA, ROW filings and post-marketing experience
• Experience with biologics and/or drug-device combination products a plus
• Is driven by a commitment to patients, and appreciation of clinical trial participants
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, and quality

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.