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 recently in-licensed a late-stage product, atrasentan, and plans to initiate a phase 3 trial for chronic kidney disease by the first half of 2021. Our pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing 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 40 employees and are based in Vancouver, British Columbia and Seattle, Washington.
Chinook has an opportunity for an experienced and versatile Head of Medical Writing to establish and lead the medical writing function within Chinook. As a key member of Chinook’s Clinical Development team, the Head of 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.
• Lead the development, authoring, and publishing of clinical protocols, clinical study reports, investigator brochures, informed consents, clinical trial disclosures, statistical analysis plans, Investigational New Drug (IND) applications, annual reports, NDAs, MAAs and other documents to support global product development.
• Lead the development, authoring, and submission of 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 the medical writing function, including managing 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.
• Consideration given to candidates with therapeutic experience in kidney disease.
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 disability or any other federal, state, provincial or local protected ground.
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