Summit Therapeutics, Inc.
Corporate Counsel, CMC/Supply Chain
Summit Therapeutics, Inc., Princeton, New Jersey, us, 08543
Overview
Location: Princeton, NJ / Miami, FL / Menlo Park, CA (on-site 4x a week) About Summit Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi Phase III, ivonescimab with chemotherapy vs placebo with chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who progressed after a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 Phase III, ivonescimab with chemotherapy vs pembrolizumab with chemotherapy in first-line metastatic NSCLC. HARMONi-7 Phase III, ivonescimab monotherapy vs pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression. Ivonescimab is an investigational therapy and is not approved by regulatory authorities in Summits license territories, including the United States and Europe. It was approved for marketing in China in May 2024. Ivonescimab has been granted Fast Track designation by the FDA for the HARMONi trial setting. Role: Corporate Counsel, CMC/Supply Chain
The Corporate Counsel, CMC/Supply Chain is responsible for supporting the review, negotiation, and execution of critical company contracts across multiple departments. This position is part of the Legal Department and partners primarily with CMC/Supply Chain as well as clinical, quality, finance, research & development, IT and other internal clients to draft, review, and negotiate contracts that protect the company from risk, support business objectives, and ensure compliance with company guidelines. Responsibilities
Serve as the primary legal liaison for the companys international CMC/supply chain business team Draft, review, and negotiate clinical and commercial supply and manufacturing agreements, statements of work, change orders, technical transfer agreements; vendor master service agreements and statements of work; real estate leases/subleases; professional services agreements; agency/placement agreements; IT/software license agreements; and confidentiality or non-disclosure agreements Liaise between internal business units and external parties; escalate matters as necessary to reduce risk and meet business objectives Ensure budgets, milestones, and KPIs align with business needs and company policies Respond promptly to complex inquiries regarding contract obligations and revisions Identify risks and issues and suggest alternatives that meet business objectives while reducing risk Prepare and disseminate information regarding contract status, compliance, modifications, etc. Work with Intellectual Property Counsel to ensure appropriate handling of IP issues in agreements Interact with Compliance and Quality Assurance to ensure proper handling of compliance and 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 contract status or issues Handle miscellaneous legal tasks or special assignments as needed All other duties as assigned Experience, Education, and Specialized Knowledge
Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing Minimum of 5 years of contracting and negotiation experience at a law firm and/or in-house with a pharmaceutical, medical device, or healthcare company Prior CMC/supply chain contract negotiation experience with a pharmaceutical company Precise drafting and strong legal analysis skills; knowledge of regulations, statutes, and industry guidelines impacting pharmaceutical R&D and contracts including data privacy Proficient with Word; working knowledge of Excel and Microsoft Access Excellent written and oral communication skills; ability to work with all levels of management Ability to comprehend and manage complex contracts and multiple projects Strong interpersonal skills and teamwork orientation Ability to diagnose legal problems and present creative solutions Strong organizational and planning skills with meticulous attention to detail Ability to work independently and collaboratively; flexible in a changing growth environment Works well under pressure to meet deadlines Salary: The pay range for this role is $168,500 - $198,500 per year. Actual compensation is based on factors including skill set, depth of experience, certifications, and location. The total package may include bonus, stock, benefits, and/or other variable compensation. Summit does not accept referrals from employment businesses or agencies. All agencies must contact Summits Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring candidates. Seniority level
Mid-Senior level Employment type
Full-time Job function
Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x. Get notified about new Corporate Lawyer jobs in Princeton, NJ. #J-18808-Ljbffr
Location: Princeton, NJ / Miami, FL / Menlo Park, CA (on-site 4x a week) About Summit Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi Phase III, ivonescimab with chemotherapy vs placebo with chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who progressed after a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 Phase III, ivonescimab with chemotherapy vs pembrolizumab with chemotherapy in first-line metastatic NSCLC. HARMONi-7 Phase III, ivonescimab monotherapy vs pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression. Ivonescimab is an investigational therapy and is not approved by regulatory authorities in Summits license territories, including the United States and Europe. It was approved for marketing in China in May 2024. Ivonescimab has been granted Fast Track designation by the FDA for the HARMONi trial setting. Role: Corporate Counsel, CMC/Supply Chain
The Corporate Counsel, CMC/Supply Chain is responsible for supporting the review, negotiation, and execution of critical company contracts across multiple departments. This position is part of the Legal Department and partners primarily with CMC/Supply Chain as well as clinical, quality, finance, research & development, IT and other internal clients to draft, review, and negotiate contracts that protect the company from risk, support business objectives, and ensure compliance with company guidelines. Responsibilities
Serve as the primary legal liaison for the companys international CMC/supply chain business team Draft, review, and negotiate clinical and commercial supply and manufacturing agreements, statements of work, change orders, technical transfer agreements; vendor master service agreements and statements of work; real estate leases/subleases; professional services agreements; agency/placement agreements; IT/software license agreements; and confidentiality or non-disclosure agreements Liaise between internal business units and external parties; escalate matters as necessary to reduce risk and meet business objectives Ensure budgets, milestones, and KPIs align with business needs and company policies Respond promptly to complex inquiries regarding contract obligations and revisions Identify risks and issues and suggest alternatives that meet business objectives while reducing risk Prepare and disseminate information regarding contract status, compliance, modifications, etc. Work with Intellectual Property Counsel to ensure appropriate handling of IP issues in agreements Interact with Compliance and Quality Assurance to ensure proper handling of compliance and 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 contract status or issues Handle miscellaneous legal tasks or special assignments as needed All other duties as assigned Experience, Education, and Specialized Knowledge
Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing Minimum of 5 years of contracting and negotiation experience at a law firm and/or in-house with a pharmaceutical, medical device, or healthcare company Prior CMC/supply chain contract negotiation experience with a pharmaceutical company Precise drafting and strong legal analysis skills; knowledge of regulations, statutes, and industry guidelines impacting pharmaceutical R&D and contracts including data privacy Proficient with Word; working knowledge of Excel and Microsoft Access Excellent written and oral communication skills; ability to work with all levels of management Ability to comprehend and manage complex contracts and multiple projects Strong interpersonal skills and teamwork orientation Ability to diagnose legal problems and present creative solutions Strong organizational and planning skills with meticulous attention to detail Ability to work independently and collaboratively; flexible in a changing growth environment Works well under pressure to meet deadlines Salary: The pay range for this role is $168,500 - $198,500 per year. Actual compensation is based on factors including skill set, depth of experience, certifications, and location. The total package may include bonus, stock, benefits, and/or other variable compensation. Summit does not accept referrals from employment businesses or agencies. All agencies must contact Summits Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring candidates. Seniority level
Mid-Senior level Employment type
Full-time Job function
Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x. Get notified about new Corporate Lawyer jobs in Princeton, NJ. #J-18808-Ljbffr