Compliance Manager, Transparency

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

HARMONi:
Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3:
Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7:
Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

HARMONi-GI3:
Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

The Compliance Manager, Transparency, is responsible for the monitoring and reconciliation of transactions to ensure data is accurate and compliant with the Sunshine Act, the company’s policies and procedures related to reportable transfers of value, and other applicable law. The Compliance Manager, Transparency is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events as required by federal and state government reporting and regulations.

• Support the company’s transparency reporting activities in accordance with all applicable laws and company policies for Healthcare Providers (HCPs) and Healthcare organizations (HCOs)
• Ensure correct reporting for all Transfers of Value (TOV) from the company to the reportable HCPs and support HCP dispute resolutions.
• Achieve transparency monthly, quarterly, and annual reporting deadlines with accurately reported data as well as conduct weekly data scrubbing for submission into the reporting system.
• Maintain up-to-date knowledge of Sunshine Act transparency reporting requirements to assess general data quality issues that may impact ability to report information to the applicable agencies.
• Resource for day-to-day processes related to compliance with Sunshine Act Transparency, analyze and determine the best course of action for each inquiry/problem, while producing timely reports and providing supporting documentation for audits.
• Support the implementation of transparency monitoring policies and procedures and training on them.
• Provide support in the annual certification process.
• Partner with multiple stakeholders throughout the Company (e.g., Legal, Clinical Operations, Medical Affairs, Sales and Marketing, HR, Internal Audit, QA)…