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 Medical Director, Clinical Development will be responsible for supporting two clinical programs in Chinook’s pipeline and will be the medical representative for global regulatory interactions, statistical analysis plans, and study conduct. The position will report to the Vice President, Clinical Development, and will be a key member of the clinical development leadership team. The Medical Director, Clinical Development will be a global medical monitor and will support life cycle management planning. The role will partner with clinical operations, biometrics, regulatory affairs, quality assurance, pharmacovigilance, and medical affairs to produce high quality pivotal trial that supports successful global registrations and launch.

Responsibilities include:

• Execution of clinical and regulatory strategy for Chinook’s assets in renal disease including supporting early and late-stage programs.
• Collaborate with physicians, scientists, regulatory professionals (etc.), to develop and execute clinical trials from beginning to end.
• Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and safety data review.
• Medical strategy for life cycle management planning for these assets.
• Ensure that clinical development programs are compliant and conducted in accordance with applicable regulatory requirements and guidelines.
• Train/guide field medical directors on protocols and messaging.
• Evaluate and train potential clinical investigators on protocols and clinical data.
• Provide clinical leadership to publication strategy and execution.
• Serve as the medical office accountable for ensuring appropriate precautions are taken to minimize risk to patients participating in clinical studies.
• Update key documents as new safety information becomes available.
• Develop and maintain strong medical relationships with all external constituents and consultants, including thought leaders, clinical trial investigators, academic centers, community-based trials consortia, and advocacy groups.
• Work with the VP, Clinical Development and other key executives on business development and alliance management issues which can leverage the company’s scientific expertise.
• Contribute to the development and maintenance of a positive team-focused company culture.

Education, Experience, and Skills:

• Medical degree required with 5+ years of post-fellowship experience and 3+ years of industry experience.
• Expertise in nephrology, immunology, and/or rare drug development is preferred.
• Strong leadership skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget.
• Experience in the execution of early, mid, and late-stage development programs.
• Skilled at critically evaluating business development opportunities from the clinical perspective.
• Thorough understanding of GCP and ICH guidelines governing the conduct of clinical trials, good working knowledge of FDA and EMA regulations and expertise in the execution of clinical trials, particularly those relating to rare disease settings.
• Solution-oriented, with a demonstrable track record of identifying and solving difficult clinical development challenges in a competitive clinical trial landscape.
• 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 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.