About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.
About the Role:
The Site Engagement Senior Manager will focus on developing, implementing, and managing site contracting strategies, site payment processes, and financial reporting in support of SpringWorks' multiple clinical development programs. The ideal candidate is an all-around team player who is passionate, enthusiastic, has excellent communication skills, and thrives under pressure and deadlines.
Proactively manage clinical site contracting and site payment activities, ensuring adherence to department strategy, company policies and procedures, as well as legal, government and regulatory requirements where relevant.
Build partnerships with clinical operations, legal, finance, and other departments as appropriate to ensure that site contracting needs are met and handled in an optimal and efficient manner.
Establish and support clinical site relationships.
Negotiate final site budgets with input from functional stakeholders in clinical operations, finance and legal, ensuring adherence to Fair Market Value (FMV) thresholds.
Facilitate the review and execution of Site Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and CTA amendments.
Meet with study leads as needed to review progress metrics and document metrics in centralized database.
Establish and maintain site contracting and site payment SOPs.
Manage document translations as needed.
Assist with strategic direction for establishing outsourcing-related business practices, including development of standard pricing, budgeting and reporting processes, contractual language and documentation, payment terms and other standards.
Assist study managers with preparation of monthly grant accruals and quarterly grant forecasts.
Work closely with finance, program management, and clinical operations to ensure the assumptions for studies/projects are aligned.
Administer clinical trial insurance as necessary on global programs.
Assist study teams with invoice disputes through resolution.
Participate in special projects and/or initiatives to help achieve business objectives.
Perform other duties and responsibilities as assigned.
About You: Required Education, Skills, and Experience
Education: Bachelors in Life Sciences, Business, Finance, or related field, or equivalent industry experience.
7+ years of global site contract and payment management experience
Operational knowledge of clinical trial study execution activities (e.g., study start-up, maintenance, and closeout activities).
Knowledge and experience related to managing relationships with CROs and/or other technical service providers.
Demonstrate clear understanding of clinical trial-related costing, including initial budget creation, forecast updates, monthly/quarterly accruals and expense reconciliation.
Thorough understanding of the operational impact of proposed changes to study protocols, timelines, and budget.
Familiarity with GCPs and applicable regulatory and legal requirements governing the conduct of clinical trials.
Advanced MS Office skills, especially Excel.
Ability to influence key stakeholders and decision makers as an individual contributor.
Can negotiate skillfully in tough situations with both internal and external groups.
Excellent verbal & written cross-functional communication skills to ensure optimal level of engagement with all key stakeholders.
Ability to work in a fast-paced environment, prioritize appropriately, manage change, and handle multiple tasks simultaneously.
Able to work independently and autonomously.
Ability to travel approximately < />
Preferred Education, Skills, and Experience
Are you a SpringWorker?
How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?
At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we're in it together. We are looking for ambitious, smart, and hardworking colleagues to join our growing team.
Organization SpringWorks Therapeutics
Employee Status Regular Full -Time
Benefits Competitive compensation and benefits package
SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual's age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
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Springworks Therapeutics, Inc.