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 of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory environment. Global regulatory experience is required. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.
Role and Responsibilities:
Provide scientific and biological regulatory guidance to project teams and key sub-teams at the clinical study level, applying knowledge of biological sciences and the regulatory requirements governing the clinical development of biological therapeutics.
Assess, develop, and implement competitive global regulatory strategies for ivonescimab , taking into consideration the biological and scientific aspects of the therapeutic, applicable regulatory requirements, and potential risks and mitigation strategies.
Independently manage regulatory activities at the molecule and clinical study levels, including Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions; review and approve investigator document packages and associated FDA submissions; and oversee other day-to-day regulatory activities associated with the clinical development of the biological therapeutic.
Apply broad scientific, biological, and technical knowledge, together with an understanding of applicable government regulations, in evaluating and addressing regulatory requirements throughout the clinical development process.
Present and communicate study-level regulatory activities to project teams, providing interpretation and application of regulatory requirements in the context of the scientific and biological aspects of the clinical studies.
Maintain effective working relationships with regulatory agencies and subject matter experts to coordinate written responses to agency queries, track…