Corporate Counsel, Clinical Contracts

🕒 Maio 27

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Summit Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2003

🧬 Biotecnologia

💊 Farmacêutico

🔥 Investimento no último ano

💰 $500.000.000 Post-IPO Equity - Summit Therapeutics em 2025-10

Biotechnology • Pharmaceuticals

A Summit Therapeutics, Inc. é uma empresa biofarmacêutica especializada em oncologia, focada na descoberta, desenvolvimento e comercialização de novas terapias medicinais para melhorar a qualidade e a duração de vida de pacientes com necessidades médicas não atendidas. A empresa está avançando com o ivonescimab (SMT112), um novo anticorpo biespecífico que tem como alvo PD-1 e VEGF, através de múltiplos ensaios clínicos de Fase 3 para o câncer de pulmão de não pequenas células e outros tumores sólidos sob licença da Akeso. A Summit enfatiza o desenvolvimento clínico, estratégias de registro regulatório e potencial comercialização em seus territórios licenciados enquanto promove opções de tratamento que beneficiam tanto pacientes quanto cuidadores.

Descrição

• 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 Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements • Interacts with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters • Interacts with Quality Assurance to ensure appropriate handling of quality matters. • Prepare template agreements, modify existing templates and prepare unique agreements as required • Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts • Handle miscellaneous legal tasks or special assignments on an as-needed basis • All other duties as assigned

🎯 Requisitos

• Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing • Minimum of 5+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company, with a minimum of 2+ years reviewing and negotiating Clinical Trial Agreements (U.S. and ex-U.S) • Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including data privacy • Proficient with Word and have a working knowledge of Excel and Microsoft Access • Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel • Strong organizational and planning skills and meticulous attention to detail • Self-starter with the ability to work independently as well as collaboratively in a team environment • Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment • Must be flexible due to rapidly changing business environment for a growth company.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options