ZipRecruiter
Corporate Counsel, CMC/Supply Chain
ZipRecruiter, Menlo Park, California, United States, 94029
Job Description
Corporate Counsel, CMC/Supply Chain
Location: Princeton, NJ / Miami, FL/ Menlo Park, CA oniste 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 is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role
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 from other departments to draft, review, and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities
Serve as the primary legal liaison for the company’s 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
Liaises 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
Ensure budgets, milestones, and KPIs align with business needs and company policies
Promptly respond to complex inquiries regarding contract obligations and revisions
Identify risks and issues, suggest alternatives that meet company business objectives while also reducing company risk
Prepares and timely disseminates information regarding contract status, compliance, modifications, etc.
Work with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements
Interacts with Compliance and Quality Assurance to ensure appropriate handling of compliance and quality matters, respectively
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
Experience, Education and Specialized Knowledge and Skills
Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing.
Minimum of 5 years of experience with contracting and negotiation 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, 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.
Able to comprehend and manage business contracts and other complex documents
Able to handle multiple projects in a timely manner
Strong interpersonal skills including a strong sense of being a team player
A keen understanding of business and the ability to diagnose legal problems and present positive, creative solutions and alternatives for management
Strong organizational and planning skills and meticulous attention to detail
Able to work independently while exercising initiative, flexibility and good judgment
Works well under pressure to meet specific deadlines
Self-starter with the ability to work independently as well as collaboratively in a team environment
Must be flexible due to rapidly changing business environment for a growth company
The pay range for this role is $168,500 - $198,500 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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Location: Princeton, NJ / Miami, FL/ Menlo Park, CA oniste 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 is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role
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 from other departments to draft, review, and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities
Serve as the primary legal liaison for the company’s 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
Liaises 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
Ensure budgets, milestones, and KPIs align with business needs and company policies
Promptly respond to complex inquiries regarding contract obligations and revisions
Identify risks and issues, suggest alternatives that meet company business objectives while also reducing company risk
Prepares and timely disseminates information regarding contract status, compliance, modifications, etc.
Work with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements
Interacts with Compliance and Quality Assurance to ensure appropriate handling of compliance and quality matters, respectively
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
Experience, Education and Specialized Knowledge and Skills
Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing.
Minimum of 5 years of experience with contracting and negotiation 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, 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.
Able to comprehend and manage business contracts and other complex documents
Able to handle multiple projects in a timely manner
Strong interpersonal skills including a strong sense of being a team player
A keen understanding of business and the ability to diagnose legal problems and present positive, creative solutions and alternatives for management
Strong organizational and planning skills and meticulous attention to detail
Able to work independently while exercising initiative, flexibility and good judgment
Works well under pressure to meet specific deadlines
Self-starter with the ability to work independently as well as collaboratively in a team environment
Must be flexible due to rapidly changing business environment for a growth company
The pay range for this role is $168,500 - $198,500 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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