Senior Director, Clinical Trial Startup & Amendments
Job ID: 28135
Type: Regular Full-Time
Location: US-WA-Seattle
Category: Clinical Research Support Services
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
The CRS Senior Director, Clinical Trial Startup & Amendments, will provide senior operational leadership for clinical trial startup and amendments implemented at the main campus and Fred Hutch Community Sites. The role is a key leadership position within Clinical Research Support, the central clinical trials office at Fred Hutch that serves Fred Hutch and the UW/Fred Hutch/Seattle Children's Cancer Consortium and oversees 4+ teams composed of 40+ FTEs in a rapidly growing area of the operation. The incumbent reports to the AVP, Clinical Trial Startup, Financial Management & Strategic Initiatives. The individual who holds this role exemplifies the Fred Hutch mission, vision and values and acts to support & enhance every aspect of our clinical research support activities.
Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.
Responsibilities
- Define direction and enhance workflows to deliver integrated startup services & implementation of post startup amendments for oncology trials that include investigator-initiated, and industry sponsored trials conducted at the main campus and the Fred Hutch Community Sites.
- Expand current central startup services to include structured project management of early feasibility, site qualification processes, and research group reviews, prior to studies formally entering the startup pipeline.
- Integrate study financial/regulatory startup activities with clinic implementation activities including orders development and implement end-to-end project management of study startup.
- Scale the central startup team to support higher volumes.
- Drive continuous process improvement to maintain startup timelines of less than 100 days for intake to open to accrual.
- Expand post start-up amendments service.
- Integrate study financial/regulatory management for amendments with clinical implementation & orders management.
- Drive continuous process improvement to maintain amendments implementation timelines as necessitated by subject activity on trials.
- Partner with CRS finance and drive continuous process improvement to maintain a complete feedback loop from post award activity into study startup & amendments workflows.
- Define and maintain quality, performance, and utilization metrics; report key measures to leadership identifying risk, and opportunities for growth and improvements.
- Integrate key workflow improvement technologies such as REDCap, Zendesk, Smart Sheet and OnCore CTMS into team workflows.
- Help implement key model improvements over the next 1-3 years such as enhanced approaches for MCA development, coding, pricing, and contracts for the Oncology study portfolio.
- Build and maintain flexible staffing model, be able to determine metric driven staffing levels, select, develop, and evaluate personnel to ensure efficient and scalable operation to serve needs of expanding portfolio.
- Create, refine, and maintain operational policies, Standard Operating Procedures (SOPs), and quality assurance processes; hold teams accountable for adhering to policies and best practices.
- Oversee changes in operations as necessary and develop systems for continuous monitoring; standardize individual and team performance metrics.
- Define and implement innovative outreach, hiring, onboarding, and training strategies that create a steady pipeline of talent to support the growth and needs of the trial portfolio.
- Promote equity, diversity, and inclusion in all aspects of cancer clinical trial conduct including hiring a diverse and inclusive workforce.
- Form strong partnerships with disease group faculty and administrative leaders, developing standard report-outs for each centrally managed portfolio.
- Guide the successful implementation of training programs including new staff training, ongoing refresher training and mentoring opportunities for staff at all levels of experience.
- Maintain defined career pathways for project managers, budget specialists, reg coordinators and clinical trial nurses, advocate and manage resources for professional development opportunities.
- Remain keenly focused on team building and fostering a culture of excellence across teams.
Qualifications
MINIMUM QUALIFICATIONS:
- Bachelor's degree
- Minimum eight (8) years' experience in study start-up/activation with a minimum of five (5) years in the direct management of oncology clinical trials, preferably at an Academic Medical Center, NCI Cancer Center, or Research Institute, or similar organization
- Minimum six (6) years' professional experience managing teams. Strong leadership skills are required to lead resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:
- manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day division operations.
- effectively lead individual teams as well as act collaboratively across an organization.
- Ideal candidates will demonstrate high level executive functioning skills, strong collaboration and communication, and the ability to build and maintain strategic relationships.
- Demonstrated track record of hiring, training, and mentoring a team of clinical trial professionals.
- Knowledge and working understanding of laws, regulations, and policies that govern clinical research.
PREFERRED QUALIFICATIONS:
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
The annual base salary range for this position is from $181,438 to $302,390, and pay offered will be based on experience and qualifications.
This position may be eligible for a sign-on bonus.
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.
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