Associate Director, Medical Affairs Operations

About Summit 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.

About Summit 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

Non-small Cell Lung Cancer (NSCLC)

• 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.

Colorectal Cancer (CRC)

• 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.

Overview of Role: The Associate Director, Medical Affairs Operations (AD), is responsible for leading and managing all operational aspects of the Medical Affairs team to ensure the effective execution of strategic initiatives. This role serves as a key liaison between internal stakeholders, external partners, and cross-functional teams, facilitating timely communication and alignment of project objectives. The AD will oversee process improvement efforts, contribute to the development and implementation of medical affairs policies and procedures, and support compliance with regulatory requirements.

The AD will focus primarily on US activities and will collaborate closely with its European counterpart.

Role And Responsibilities

• Manage the implementation of all operational components for medical affairs projects, including coordinating and negotiating CDAs, contracts, and sponsorship agreements with both external vendors and internal stakeholders.
• Collaborate with compliance and finance teams to ensure that thorough Fair Market Value assessments are performed on all external payments in accordance with company and industry standards.
• Uphold precise documentation and reporting practices to promote compliance and transparency, ensuring adherence to regulations such as FMV and the Sunshine Act.
• Design and roll out operational policies, procedures, and best practices aimed at enhancing efficiency, quality, and regulatory compliance across Medical Affairs operations.
• Evaluate vendor proposals, statements of work, and contracts for their operational viability and…