Program Operations Director

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 Program Operations Director is a high-level career position which is responsible for the fiscal management, clinical and daily operations of research projects conducted by faculty within the Clinical Research Division. The Program Operations Director provides support in grants and contract management (Pre- and Post- Award), budget development, negotiation and monitoring, regulatory administration, and general day-to-day operations of the program faculty. This position requires understanding of oncology research protocols and translation of the research needs into operations. The financial portfolio is comprised of various sources of NIH, foundation, industry, professional society, internal pilot, subawards, and institutional support and includes regulated activities.

This position will report to the Associate Vice President in the Clinical Research Division and will act independently in performing responsibilities, partnering with program faculty and interfacing with other departments as needed to provide research administration.

This position works independently in developing operational goals and determining courses of action to accomplish goals. They also advise PIs and the Associate Vice President on relevant matters, develop effective solutions to administrative challenges, and provide input to broader program and division planning as needed.

This role can be hybrid-remote or on-campus, with a preference for on-campus. There will be a period of required on-campus training. Applicant must specify preference during the application process.

Responsibilities

 Funding Source Administration

• Responsible for all pre- and post-award operations for each faculty in their assigned portfolio, providing operational oversight of the administrative implementation and financial management of interventional clinical research studies and associated agreements within the Program.
• Manage and oversee the fiscal and operational lifecycle of clinical trial protocols, from study implementation through closeout, to include:
• Create, negotiate, and finalize budgets based upon protocol requirements.
• Partner with clinical sites of practice to obtain research pricing.
• Facilitate Clinical Trial Agreement review in conjunction with General Counsel, escalate CTA language as needed.
• Collaborate with and oversee clinical research staff to ensure appropriate logistical implementation of protocols within our clinical sites of practice. Attend study implementation meetings.
• Tracking and auditing of participant research procedures to ensure compliance with Medicare coverage requirements.
• Amend and negotiate budgets as needed through the life of a study.
• Manage multi-site components as needed.
• Manages grant submissions and post-award activity by conducting tasks such as:
• Preparing grant application budgets
• Completing/collating of all technical/non-scientific steps and assigned technical or scientific portions of funding/grant submissions
• Review budgets, identify discrepancies and provide recommendations to the PI on scenarios to resolve the issues with appropriate stakeholders
• Identify/forecast personnel and other resource requirements (including long-range forecasting across multiple budget years)
• Working with faculty to respond to requests from other departments and external organizations Perform post-award activities, including annual progress report submission and sub-award activation and management.
• Manage non-sponsored budgets, such as discretionary accounts and gift funds.
• Prepare monthly budget summaries and reports for PIs.
• Track all projects in startup, developing plans with parallel workstreams and clear timelines, communicating between stakeholders, and holding accountable the team members whose input is required.
• Ensure project invoices are submitted and sponsor payments are received in a timely manner.

Fiscal Support

• Develop, monitor, track and forecast the budgets for a portfolio of projects with multi-variable aspects (multi-site, sub awards, clinical trials, milestone-based budgets etc.)
• Monitor spending for adherence to grant/contract guidelines and policies, as well as internal policies.
• Develop, run, and analyze reports to identify funding issues and develop recommendations.
• Develop customized report formats to share information with each faculty member and for broad audiences across the organization.
• Provide ongoing cost analysis for studies to ensure projects are adequately funded; provide budget information to internal partners for negotiation of budget revisions with sponsors.

Regulatory Support

• Prepare non-scientific portions of regulatory applications/submissions related to human subjects research.
• Identify missing regulatory components that are required and resolve issues to ensure successful submission, modification, or renewal.
• Serve as a central point of contact to answer questions and facilitate solutions.
• Prepare/consult/advise PIs and maintain Data/Material Use Agreements and other data compliance documentation.

Administrative Support

• Partner with the Associate Vice President to develop short- and long-term goals, procure necessary resources and determine courses of action to accomplish goals for the research administration team.
• Identify administrative needs for the department or PIs; prioritize and ensure related tasks are completed timely.
• Delegate appropriate tasks to junior RAs and/or Administrative Coordinator and follow up as necessary.
• Participate in divisional or institutional improvement projects and problem resolution related to research administration.
• May supervise administrative staff, to include hiring, performance evaluation, and professional development.

Qualifications

MINIMUM QUALIFICATIONS

• Bachelor’s degree in business, public administration or a related field
• Minimum of 8-10 years of federal research administration management experience
• Minimum of 3-5 years of supervisory and leadership experience
• Demonstrated success managing and engaging diverse stakeholders across a complex research portfolio
• Experience with translating science into strategy in creating and executing strategic plans
• Strong communication and budgetary skills

 PREFERRED QUALIFICATIONS

• Master's degree in public administration, business administration, or other relevant field.
• 3-5 years of experience in supporting faculty in an academic and/or research environment.
• Understanding of clinical research trial implementation and conduct, preferably with industry-sponsored clinical trials.
• Prior exposure to Oncology research and Phase 1-3 clinical trials
• Experience with pre-award and post-award grants and contracts management.
• Experience in identifying areas for process improvement and implementing associated change management strategies to successfully rollout and sustain initiatives.

This position is patient facing and/or requires access to Fred Hutch clinical facilities. As such, full COVID-19 vaccination is required as a condition of employment, without exception. Booster doses are strongly recommended but not required. If declining a booster, completion of the COVID-19 Vaccination Status Form Questionnaire and COVID-19 Booster Declination Training is required. Because of our immunocompromised patient population, there are no medical or religious accommodations available for any employee who is patient facing and/or requires access to Fred Hutch clinical facilities. Only employees whose positions are fully remote, who are not patient facing and/or require no access to clinical facilities, may apply for medical or religious accommodations. As a condition of employment, newly hired employees must provide proof of vaccination before their first day of employment.

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 $123,203.00 to $194,739.00 and pay offered will be based on experience and qualifications. This position may be eligible for relocation assistance or 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 (22 days per year), paid sick leave (up to 30 calendar days per occurrence of a qualifying reason), paid holidays (up to 13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 12 months for professor track faculty, up to 6 months for other scientific staff).