Program Operations Director, Solid Tumor Program

Company: 340B Health
Location: Seattle
Posted on: January 23, 2025

Job Description:

OverviewFred 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 makes 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 responsible for the fiscal management, clinical, and daily operations of research projects conducted by solid tumor faculty employed by the Clinical Research Division of Fred Hutch Cancer Center. The Program Operations Director of the Solid Tumor program oversees the administrative team that provides support to the faculty within the program. The position oversees and 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 an understanding of oncology research protocols and the 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, with a dotted line to the CRD Section Head of the Solid Tumor program, and will act independently in performing responsibilities, partnering with program faculty and interfacing with other departments as needed to provide comprehensive research administration. This position works independently in developing operational goals and determining courses of action to accomplish goals. They also advise faculty (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 is expected to be present in person on the South Lake Union Seattle campus at least 3 days per week in general.ResponsibilitiesFunding Source Administration

• Responsible for oversight of 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, which includes tasks such as:
  • Create, negotiate, and finalize budgets based upon protocol requirements.
  • Partner with clinical sites of practice to obtain research pricing.
  • Facilitate Clinical Trial Agreement (CTA) review in conjunction with General Counsel, escalate CTA language as needed.
  • Collaborate and develop strong working relationships with Clinical Research Support (CRS) staff to implement trials, hand off post-award work, and budgetary oversight, when appropriate.
  • Collaborate with and oversee clinical research staff to ensure appropriate logistical implementation of protocols within our clinical sites of practice. Attend study implementation meetings.
  • Collaborate with colleagues at the University of Washington who could be involved in pre- and/or post-award operations.
  • 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 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.Management
          • Partner with the Associate Vice President and Section Head, Solid Tumor Program, to develop short- and long-term goals, procure necessary resources, and determine courses of action to accomplish goals for the team.
          • Serve as a resource to all staff in the program (admin, study staff, sci staff, etc.), including training and support on navigation of Fred Hutch systems, processes, etc. Examples include procurement, purchasing, compliance/regulatory systems.
          • Identify administrative needs for the department or PIs; prioritize and ensure tasks are completed timely.
          • Delegate appropriate tasks to Research Administrators, Administrative Coordinators, and other staff, and follow up as necessary.
          • Develop strong partnerships with colleagues across the enterprise, including those from different departments or partner organizations, such as University of Washington, Seattle Children's, etc. Participate in divisional or institutional improvement projects and problem resolution related to research administration.
          • Meet with all assigned PIs (and other scientific staff or research associates) on a regular basis to identify and assess administrative needs and gaps. Ensure progress to improve support and fill gaps. Escalate challenges or unmet needs to leadership, as needed.
          • Oversee the HR systems and practices for the individuals in your assigned area, ensuring adherence to Fred Hutch and HR policies and procedures.
          • Supervise assigned staff and assist with supervising research staff, to include hiring, performance evaluation, and professional development.QualificationsMINIMUM QUALIFICATIONS
            • Bachelor's degree in business, public administration, or a related field.
            • 8+ years of research administration experience.
            • 5+ years of supervisory/leadership experience.
            • Demonstrated success managing and engaging diverse stakeholders in complex environments.
            • Experience with translating science into strategy in creating and executing strategic plans.
            • Strong communication and budgetary skills.PREFERRED QUALIFICATIONS
              • Master's degree in public, health, or business administration, or other relevant field.
              • 5+ years of clinical trials management experience.
              • 5+ years of experience in supporting faculty in an academic and/or research environment.
              • 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.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 $130,728 to $206,585, and pay offered will be based on experience and qualifications. 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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Keywords: 340B Health, Edmonds , Program Operations Director, Solid Tumor Program, Executive , Seattle, Washington