Director of Clinical Trial Operations

We are seeking a detail oriented and strategic Clinical Trial Operations Director to oversee clinical study operations within our healthcare organization. The successful candidate will oversee resourcing, developing, training, and managing a successful clinical trial operations team. This leader is responsible for the planning, oversight, management, and delivery of clinical development programs within Seattle Children's Therapeutics (SCTx), with a focus on early phase cell and gene therapy clinical trials.

The Director will ensure that early phase trials are executed with efficiency, collaboration, and a service mindset. This leader of Clinical Trial Operations will partner with investigators/sponsors as well as the core clinical, regulatory, data science, research and manufacturing teams to deliver seamless research experience while upholding the highest standards of safety, compliance, and data quality. They will manage the financial and budgetary aspects of clinical study development for trials conducted by SCTx.

• Bachelor's in nursing, Life Sciences, Healthcare Administration, or related field.
• Minimum 8 years of relevant experience with expertise in the areas of clinical trial operations and 5 years in a leadership/manager role with increasing responsibility overseeing early phase oncology trials; developing, implementing, and leading early-phase (I/II) clinical trials. and FDA regulations and guidelines including the IND
• Direct experience managing early phase cell, gene and protein therapy trials and/or stem cell transplant clinical trials is strongly preferred.
• Proven success in building trial operations infrastructure, including SOP generation, managing contracts and clinical budgets; managing trial operations supporting clinical product development from early to late stage trials.

N/A.

• Masters in nursing, Life Sciences, Healthcare Administration, or related field.
• 10 years of relevant experience with expertise in the areas of clinical trial operations

$ - $ per year

This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.

This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors .

Seattle Children’s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Additional details on our benefits can be found on our website (Use the "Apply for this Job" box below). .

As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine.

Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report’s top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of…