Seagen

Senior Investigator Budgets Analyst (Remote)

Development - Remote, Bothell, United States

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Sr. Investigator Budgets Analyst is responsible for supporting the overall budget development process for site-facing budget templates. The position focuses on the coordination of multiple activities required to manage budget development to support clinical studies from start to close-out. The position requires the ability to work cross functionally to ensure timely support of site activation. Training of internal Clinical Contracting team on budget processes, Company best practice, and negotiation strategy. Responsible for development of process and acceptable guidelines for approvable budgetary requirements. The position will serve as a key contributor to clinical contracts process improvements, as well as quality initiatives related to the function.

Essential Functions:

• To accomplish this job successfully, an individual must be able to perform with expertise, each essential function listed below satisfactorily:
• Investigator Budget Build
• Works with Clinical Operations, Finance, Legal, Clinical Contracting, Functional Service Providers, and Clinical Research Organizations to ensure proper clinical trial budget development, training and dissemination occurs.
• Accountable for drafting, reviewing, and finalizing the creation of global clinical trial budget templates for Phase I through IV studies in accordance with Fair Market Value and industry best practices. Amendment responsibility as needed as protocol requirements mandate.
• Utilizes grant planning/industry cost benchmarking tools, ICD-9/10 codes, and CPT codes to ensure standardization of budget template format.
• Collaborates with Clinical Operations as needed for clarifications, providing education on the budget development process and rationale for items in the budget template.
• Creates comprehensive parameters and tools for the Contracting team to use through the budget negotiations.
• Maintains documentation and database of approvals and for Master templates.
• Monitors timelines for all clinical studies to ensure global budgets are built within study required timelines for both original and amended protocols and delivered to business partners on time.
• Responsible and accountable for leading a meeting for budget delivery and explanation of the master template and/or Parameters to Clinical Operations, Finance, Clinical Contracting, Functional Service Providers, and/or Clinical Research Organizations to ensure proper understanding to allow a high level of negotiation.
• Supports business partners requests for ad hoc cost benchmarking analysis and global budget template development. Serves as subject matter expert for cost benchmarking and cost benchmarking tool; provides internal training and ongoing support on a global level.

General duties:

• Ensure new users are granted access to GrantPlan and provide initial training
• Assist global team with system use and provide clarifications as needed
• Point person for vendor communications and GrantPlan version updates with IQVIA
• Create Master Budget Templates in GrantPlan for Seagen users (Phase I-IV)
• Update Master Budget Templates as appropriate in terms of benchmarks and exchange rates
• Update the Master Investigator Fee Budget Template to align with Seagen’s internal processes and tools such as the new site payment system
• Continue to update the budget templates to conform with internal budget negotiation parameters and in line with current industry trends
• Contribute to Clinical Contracts team onboarding plan and curriculum
• Provides input into and supports global clinical site budgeting process and negotiation
• Collaborates and supports colleagues on the negotiation of site budgets and ancillary documents
• Applies and understands benchmark cost data, relationships, and trends to real world situations
• Support the development and delivery of site budgeting process training and documentation
• Leading ongoing process improvements and training sessions (including participating in pivotal initiatives)
• Onboarding, training, and mentoring peers on site budgeting
• Staying abreast of changes in industry standards and helping to identify new standard methodologies to contribute to continuous improvement
• Development of site budgeting process and guidance documents
• Identify training needs, formulate strategies to address training gaps, and conduct training
• Contribute to VSM quality, systems, and process initiatives
• Adhere to Clinical Development Operations or project specific quality documents (e.g., SOPs, work practices, training guides), as applicable
• Work on problems of diverse scope, as assigned by Manager/Director, where analysis of situations or data requires evaluation of identifiable factors. Exercise judgment within generally defined procedures and policies in selecting methods and techniques for obtaining solutions.

Qualifications:

• A minimum of 5+ years of relevant pharmaceutical industry experience, including 2-3 years as a Contracts/Budget Analyst, preferred Proficient with Microsoft Office software
• Proficient with IQVIA GrantPlan
• Strong communication (written and verbal) skills in order to interact with internal/external groups
• Strong analytical capabilities
• Advanced presentation skills
• Able to proactively identify opportunities, challenges/risks and implement appropriate actions
• Able to understand, clearly articulate and defend budget template budget decisions and rationales
• Thorough understanding of budgeting process and ability to summarize high-level feedback
• Can identify, communicate, and propose solutions for potential budget issues that may arise
• Knowledge of CFR and GCP/ICH requirements
• Demonstrated ability to successfully contribute as a member of a project team
• Demonstrated ability to successfully manage multiple competing priorities
• Excellent planning and organizational skills
• Effective written and verbal communication and presentation skills
• Demonstrated ability to lead by example and to encourage team members to seek solutions
• Proven interpersonal skills, including strong mentoring, and motivational skills

Education:

• Bachelor’s degree or equivalent or relevant and qualifying training/experience

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/05/2022