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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.

Required Education and Experience

Education & Experience

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.

Required Credentials

N/A.

Preferred

Masters in nursing, Life Sciences, Healthcare Administration, or related field.

10 years of relevant experience with expertise in the areas of clinical trial operations

Compensation Range

$180,884.00 - $271,326.00 per year

Salary Information

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.

Disclaimer for Out of State Applicants

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

Benefits Information

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 www.seattlechildrens.org/careers/benefits .

About Us

Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

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 medicine's most complex problems.

We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

Our Commitment

Seattle Children’s welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families. Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves.

Seattle Children’s is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.