Corporate Counsel, Clinical Contracts at Summit Therapeutics

Job description

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 Corporate Counsel, Clinical Contracts is responsible for supporting the review, negotiation, and execution of company contracts across multiple departments. This position supports the Legal Department and partners with clinical, quality, medical affairs, finance, research & development, HR, IT and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities: Collaborate with attorneys and other legal staff in other practice areas to proactively identify and address key legal issues for the business teams. Draft, review, analyze and negotiate clinical related contracts, including clinical trial agreements (including ancillary agreements, such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements), investigator sponsored studies (ISTs), collaboration and development agreements, sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft and negotiate consulting agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT software license agreements, HR benefit and contractor agreements, leases, and confidentiality or non-disclosure agreements. Liaise between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met. Promptly respond to complex inquiries regarding contract obligations and revisions Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk Reviews and tracks in-process and on-going agreements Supports company employees regarding the Contract Management process Interacts with