Chinook Therapeutics Job Description:
Director, Medical Writing
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 1b 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.
The Director, Medical Writing will be responsible for developing and authoring clinical and regulatory documents and clinical communications in support of Chinook’s early and late-stage drug development programs. This role will also lead the development of medical writing processes and infrastructure and oversee resourcing needs.
- Develop, author, and publish clinical protocols, clinical study reports, investigator brochures, informed consents, clinical trial disclosures, statistical analysis plans, clinical summaries and other medical/regulatory documents to support global product development.
- Develop, author, and submit abstracts, slides, and posters presenting clinical study data at medical congresses and the development of manuscripts for publication in peer-reviewed journals
- Partner with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.
- Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
- Drive the overall process for document development including timelines, team member engagement, content development, document review, and approvals.
- Work closely with study teams to gain a comprehensive understanding of the data supporting document development to ensure documents are scientifically accurate and meet the intended purpose.
- Prepare documents in accordance with internal standards and external regulatory guidelines.
- Develop and implement document templates, style standards, reference library, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables.
- Manage direct reports and/or third-party service providers.
Education, Experience, and Skills:
- Minimum of 8 years of clinical experience in the biopharmaceutical industry with at least 6 years direct medical writing experience.
- Bachelors degree in life sciences. Masters or doctorate degree qualification in life sciences is preferred.
- Expertise in preparing clinical regulatory documents and scientific publications.
- Prior NDA/BLA/MAA submission experience is preferred.
- Excellent written and verbal communication skills.
- Expert ability to interpret and present statistical and clinical data.
- Expert abilities in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
- Excellent project management skills to organize work and to influence and guide teams during document development.
- Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.
- Advanced knowledge of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process.
- Knowledge of clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards.
- Must have the ability to lead and prioritize multiple projects in a fast-paced environment.
- Experience managing a high performing team is preferred.
- Additional consideration given to candidates with therapeutic experience in kidney disease.
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.