Chinook Therapeutics

Manager, Clinical Trial Associates

Clinical Ops (600) - Remote, Washington

Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

Position:

The Manager, Clinical Trial Associates (CTAs) is responsible for direct line management of multiple CTAs, ensuring appropriate study resourcing, onboarding, training, and oversight to promote consistent and high-quality study operations support and maintenance of Trial Master File (TMF) inspection readiness across the portfolio. As a subject matter expert, the Manager, CTAs will support a wide range of activities including process development, study and people management support, and department and business critical initiatives/ deliverables. This position will report to an Associate Director or above.

Responsibilities include:

• Oversee day-to-day activities of the CTA team providing guidance, coaching, and supporting issue escalation.
• Support CTA team to successfully achieve individual, business, and development goals.
• Collaborate closely with global and/or regional Clinical Study Leads to ensure appropriate CTA utilization, matrix management, performance, workload, and expectations management.
• Identify and assign resources to ensure clinical trial success.
• Provide development and growth opportunities for CTA team via training plans, quality oversight, including quality checks, and development discussions.
• Ensure appropriate training and on-time training compliance.
• Develop and maintain onboarding and training plans.
• Manage individual and team performance.
• Responsible for CTA hiring and onboarding, ensuring CTA team growth commensurate with the portfolio and infrastructure needs.
• Further cultivate the CTA team, building and maintaining a fit-for-purpose infrastructure (SOPs, Forms, Tools) contribute to strategic plans for the team’s growth and development.
• Help facilitate change management.
• Promote understanding of relevant SOPs, TMF and other clinical systems use and expectations through ongoing education and discussion.
• Initiate and lead process improvement initiatives, developing and maintaining functional best practices and ensuring consistency of implementation across studies.
• Other responsibilities and activities as assigned.
• Contribute to the development and maintenance of a positive team-focused and collegial company culture.

Location:

Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC

• This position may be located at any Chinook office location or remote (within US or Canada).

Education, Experience, and Skills:

Required

• Undergraduate degree or equivalent experience and education and at least 6+ years of relevant clinical trial management experience in the biotechnology or pharma industry.
• Experience with line management required.
• Knowledge and understanding of the Code of Federal Regulations (CFR) and Good Clinical Practice/International Council for Harmonization (GCP/ICH) as well as general knowledge and awareness of global regulatory requirements.
• Familiarity with all aspects of the clinical trial process including, but not limited to TMF maintenance, study documents, study start-up activities and study related tracking activities.
• Exceptional ability to lead and develop a team with minimum oversight, including ability to provide work direction, such as organizing, prioritizing, and professional business conduct and communication.

Preferred:

• Demonstrated critical thinking and leadership skills, proficient communicator, highly organized.
• Flexible and adaptable in constantly changing environments and growing organization with strong critical thinking skills.
• Ability and willingness to travel domestically.
• 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.

Salary Range: $125,000 - $145,000

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

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.

To Apply:

Chinook Therapeutics

Chinook Therapeutics is an Equal Opportunity Employer

Submitted: 01/28/2023