Legal Corporate Counsel - Contracts

Job Title: Legal Corporate Counsel - Contracts

Location: Menlo Park, CA US

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities

We have in-licensed Ivonescimab, which 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. We plan to initiate phase-III clinical studies in the following NSCLC indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)

Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

The Legal Corporate Counsel-Contracts provides assistance with the development, negotiation, and execution of company contracts. This position is within the Legal Department and partners with clinical, finance, research & development, market access, marketing, manufacturing and other internal clients from other departments to independently negotiate contracts that protect the company from risk and ensure compliance with company guidelines.

Role and Responsibilities:

• Draft, review, analyze and negotiate contracts relating to research, development and commercial activities which include: collaboration and development agreements, collaboration agreements, sponsored research agreements, licensing agreements, clinical trial agreements, technology transfer agreements, clinical and commercial supply agreements, market access agreements, materials transfer agreements, service agreement, agreements with contract research organizations (CROs), agreements with third party logistics (3PL) providers, specialty pharmacy distributors, wholesalers, health plans, pharmacy benefits management (PBM) companies, and group purchasing organizations, contract manufacturing agreements, advertising agency agreements, health professional consulting contracts, master services agreements, benefits/staffing/HR agreements, promotional speaker bureau agreements, sales operations agreements, vendor and service contracts, IT and consulting agreements, confidentiality or non-disclosure agreements, and market research agreements in support of the research, manufacturing agreement, GPO agreement, NDA or CDA, as well as Work Orders and Amendments thereof.
• Acts as the primary contact between the project team and/or business unit and the external party, ensuring that all legal and contractual matters are addressed efficiently and promptly
• Develop strong working relationships with functional groups and project teams.
• Responds to complex inquiries regarding contract obligations and revisions.
• Identifies risks and issues, suggests alternatives that lead to the best solution.
• Prepares and disseminates information regarding contract status, compliance, modifications, etc.
• Reviews, analyzes and tracks in-process and on-going agreements.
• Assist in implementing and maintaining a contract lifecycle management system.
• Reports the status of contracts to internal clients using established processes.
• May provide training to company employees regarding the Contract Management process
• Responsible for effectively interacting with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements.
• Effectively interacts with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters.
• Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters.
• Prepare template agreements, modify existing templates and prepare unique agreements as required.
• Generally, works to ensure clear and prompt communication with company employees, and outside parties regarding contracts.
• Handle miscellaneous legal tasks or special assignments on an as-needed basis.

Experience, Education and Specialized Knowledge and Skills:

• JD plus 5 years of experience with pharmaceutical or healthcare contracting and negotiation at a law firm and/or in-house with a pharmaceutical, medical device, or healthcare 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; professional manner. Able 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 team.
• 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

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