Sr Corporate Counsel, Contracts

Job Title: Senior Counsel, Global Contracts

Location: Menlo Park, CA

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 Senior Counsel, Global Contracts is responsible for the development, negotiation, and execution of company contracts across multiple departments. This position is within the Legal Department and reports to the VP, Legal, and partners with clinical, finance, research & development, market access, marketing, manufacturing 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:

• Develop, implement, manage, and improve contracting processes for the company, with an emphasis on standardizing, creating and reporting meaningful metrics with respect to the total number of contracts processed for review, the total number of contracts reviewed, the amount of time spent reviewing each contract (i.e., turn time), and the total time from contract in-take to signature to ensure company business objectives are met.

• Manage, train, supervise, and evaluate a dedicated legal staff comprised of attorneys, paralegals, and other staff as necessary

• Provide training to other attorneys, paralegals, legal staff, and internal clients on the contracting processes and associated metrics to ensure company business objectives are met in a timely manner.

• Collaborate with attorneys and other legal staff in other practice areas to proactively identify and address key legal issues for management.

• 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 internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters to the VP, Legal, 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.

• Identify risks and issues, suggests alternatives that meet company business objectives while also reducing company risk.

• Prepares and timely disseminates information regarding contract status, compliance, modifications, etc.

• Reviews, analyzes and tracks in-process and on-going agreements.

• Assist in implementing and maintaining an effective contract lifecycle management system, which includes the ability of the system to obtain and provide consistent metrics of performance from contract in-take through contract execution.

• Reports the status of contracts to internal clients using established processes and updated processes as necessary.

• 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.

• Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts.

• Provide regular status and metric updates to VP, Legal

• Handle miscellaneous legal tasks or special assignments on an as-needed basis.

Experience, Education and Specialized Knowledge and Skills:

• JD plus 10+ 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.

• Open to feedback, leads by example, and maintains a positive attitude.

• 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 $232,000 To $250,000 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits 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 Summits human resources department to obtain prior written authorization before referring any candidates to Summit.