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.
The Associate Director, Clinical Trial Management, will be responsible for operational planning and execution of late-stage global clinical trials. The AD, Clinical Trial Management will lead one or more pivotal trials and will manage and oversee a large internal study team as well as the assigned CRO and multiple study vendors. The AD, Clinical Trial Management will provide key support to the broader team, quality oversight of site management and monitoring activities and inspection preparation which may contribute to a New Drug Application. The AD, Clinical Trial Management will lead tactical meetings and other clinical trial management specific meetings. In addition, the AD, Clinical Trial Management may provide support to Clinical Operations lead for Global Product Team and Leadership Team presentations, providing insight and direction for operational considerations including study amendments. The AD, Clinical Trial Management may be asked to present study updates at key company meetings. The position reports to the Director, Clinical Trial Management.
- Lead, delegate and direct clinical trial management activities on a large global trial or multiple early phase studies, including but not limited to the following activities:
- Partner with investigative site personnel, CROs, and other study vendors to drive key study activities.
- Lead the evaluation, selection, and oversight of clinical trial sites.
- Provide quality oversight of site management and monitoring activities
- Contribute to the design and review of clinical trial protocols, Case Report Forms, and Clinical Study Reports.
- Develop informed consent forms and other patient-facing materials
- Facilitate information flow between clinical trial sites, study team members, CRO’s, and vendors.
- Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
- Collaborate with Clinical Project Management to help develop and maintain country, site and IP forecasts, study timelines, set site-facing milestones, and track screening and enrollment.
- Support Operations Lead and Global Product Team by offering clinical operations expertise and study level perspective to inform development of the overall project strategy and decision-making.
- Ensure clinical trial planning and execution aligns with program priorities and that any issues from clinical study teams are escalated to Global Product Team as appropriate.
- Prepare and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
- Hire, train, and develop new clinical staff and may contribute to dotted-line management of team members.
- Act as line manager to Clinical Trial Managers and other junior team members on one or more studies.
- Identify risks, anticipate issues, and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.
- Present study progress to Global Product Team/Leadership Team and company meetings as requested
- Contribute to ongoing strategy discussions with the Clinical Operations Lead and Project Managers
- Alongside the Clinical Operations lead, Quality Assurance and Inspection Team, help guide study team through inspections
- Contribute/lead ongoing initiatives within the Clinical Trial Management Department, including process improvements and SOP development
- Contribute to the development and maintenance of a positive team-focused company culture.
Education, Experience, and Skills:
- 10+ years of relevant clinical trial management experience in the biotechnology or pharma industry with BA/BS or equivalent
- 3 + years as a Senior Clinical Trial Manager on a late-stage program with experience in the full life cycle of a clinical trial
- Thorough knowledge and understanding of Code of Federal Regulations (CFR) and Good Clinical Practice/International Council for Harmonization (GCP/ICH) requirements as well as general knowledge and awareness of global regulatory requirements
- Expertise managing early and late-stage clinical trials and overseeing outsourced trial deliverables through cross-functional teams as well as CROs and other third-party vendors
- Experience managing direct reports and work deliverables through an extended team
- Experience with regulatory submissions (IND, BLA, MMA, etc.)
- Strong leadership, communication, and organization skills
- Ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Flexible and adaptable in constantly changing environments and growing organization with strong critical thinking skills
- Ability and willingness to travel up to 25% may be required if safe to do so (domestic and internationally)
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF) as well as virtual meeting technologies such as Zoom and Teams
- Kidney disease experience a plus
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.