Clinical Contracts Manager

Location:
Menlo Park, CA; Miami, FL; Princeton, NJ onsite

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 generation 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 Clinical Contracts Manager is responsible for the drafting, negotiation, and execution of company contracts across multiple departments. This position is within the Legal Department and partners with clinical operations, medical affairs, finance, research & development, IT, human resources, facilities, 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

• Draft, review, analyze and negotiate a wide range of contracts, with an emphasis on clinical trial agreements and ISTs. In addition to clinical trial agreements and ISTs, draft, review, and negotiate agreements with contract research organizations (CROs), sponsored research agreements, advisory board agreements, collaboration agreements, licensing agreements, consulting and contractor agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT/software agreements, facilities and lease agreements, human resource/employee benefit agreements, and confidentiality or non-disclosure agreements.
• Acts as the primary contact between the internal business units and external parties, ensuring that all contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met.
• Develop strong working relationships with functional groups and project teams.
• Promptly respond to complex inquiries regarding contract obligations and revisions.
• Prepares and timely disseminates information regarding contract status, compliance, modifications, etc.
• Reviews, analyzes and tracks in-process and on-going agreements.
• Reports the status of contracts to internal clients using established processes and updated processes as necessary.
• Escalate legal issues to the Sr. Corporate Counsel, as needed
• Effectively interact with Intellectual Property Counsel and Compliance to ensure appropriate handling of intellectual property and compliance issues in contract matters.
• Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters.
• Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts.
• Handle miscellaneous tasks or special assignments on an as-needed basis.
• All other duties as assigned.

Experience, Education And Specialized Knowledge And Skills

• Bachelor's degree in relevant legal or business field
• Minimum of 5+ years of experience with contracting and negotiation
• Extensive clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company
• Precise drafting and negotiation skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including GDPR and other data privacy laws.
• Experience with contract lifecycle management (CLM) systems
• Proficient with Word and have a working knowledge of Excel.
• Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel.
• Able to handle multiple projects in a timely manner
• Strong interpersonal skills including a strong sense of being a team player
• Works well under pressure to meet specific deadlines
• Must be flexible due to rapidly changing business environment for a growth company

The pay range for this role is $118,500-$139,000 annually. 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 differences 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 to obtain prior written authorization before referring any candidates to Summit.