Clinical Contracts Manager

Location

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

Ivonescimab, known as SMT
112, 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 – Evaluate ivonescimab with chemotherapy vs. placebo + chemotherapy in EGFR‑mutated, locally advanced or metastatic NSCLC who have progressed after a 3rd generation EGFR TKI.
• HARMONi‑3 – Evaluate ivonescimab with chemotherapy vs. pembrolizumab + chemotherapy in first‑line metastatic NSCLC.
• HARMONi‑7 – Evaluate ivonescimab monotherapy vs. pembrolizumab monotherapy in first‑line metastatic NSCLC with high PD‑L1 expression.

Ivonescimab is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and received Fast Track designation by the FDA for the HARMONi clinical trial setting.

The Clinical Contracts Manager is responsible for drafting, negotiating, and executing company contracts across multiple departments, ensuring risk protection, business support, and compliance with company guidelines. The position partners with clinical operations, medical affairs, finance, R&D, IT, HR, facilities, and other internal clients.

• Draft, review, analyze, and negotiate a wide range of contracts, focusing on clinical trial agreements and ISTs, but also including CRO agreements, sponsored research, advisory board, collaboration, licensing, consulting, master services, promotional speaker bureau, vendor and service contracts, IT/software agreements, facilities and lease agreements, human resources/employee benefit agreements, and confidentiality agreements.
• Act as the primary contact between internal business units and external parties, ensuring efficient resolution of contractual matters and escalating issues to reduce risk.
• Develop strong working relationships with functional groups and project teams.
• Respond promptly to complex inquiries regarding contract obligations and revisions.
• Prepare and disseminate timely information regarding contract status, compliance, and modifications.
• Review, analyze, and track in‑process and ongoing agreements.
• Report contract status to internal clients using established processes and update them as necessary.
• Escalate legal issues to the Senior Corporate Counsel as needed.
• Coordinate with Intellectual Property Counsel and Compliance on IP and compliance matters.
• Collaborate with Quality Assurance on quality related issues.
• Ensure clear and prompt communication with company employees and external parties about contract status or issues.
• Handle miscellaneous tasks or special assignments on an as‑needed basis.
• Perform all other duties as assigned.

• Bachelor’s degree in a relevant legal or business field.
• Minimum of 5+ years of experience in contracting and negotiation.
• Extensive clinical trial agreement negotiation and drafting experience (U.S. and ex‑U.S.) with a pharmaceutical company.
• Proficient drafting and negotiation skills, knowledge of regulations, 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 working knowledge of Excel.
• Excellent written and oral communication skills; ability to work effectively with all management levels.
• Ability to handle multiple projects in a timely manner.
• Strong interpersonal skills and a team‑player mindset.
• Works well under pressure to meet deadlines.
• Flexible to rapidly changing business environments in a growth company.

$118,500–$139,000 annually. Actual compensation packages are based on factors such as skill set, depth of experience, certifications, and work location. The total compensation may also include bonus, stock, benefits, and other variable components.

Seniority Level: Mid‑Senior

Employment Type:

Full‑time
Job Function:
Strategy/Planning and Information Technology

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