Description:

Non-small Cell Lung Cancer (NSCLC)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:
The Sr. Commercial Attorney, Transactions for Summit Therapeutics (the “Company”) will be integral to supporting the successful commercial/product launch of Ivonescimab. This position reports directly to the Chief Legal Officer and serves as the primary legal liaison for the review, negotiation and drafting of all Company commercial, marketing, and market access related agreements. This role requires in-depth knowledge of pharmaceutical industry regulations and the ability to advise on commercialization, market and distribution strategies.

Role and Responsibilities:

Lead the drafting and negotiation of the agreements associated with the Company's commercial activities, including but not limited to, product launches, promotional/and marketing materials, sales activities, advisory boards, speaker bureaus, patient assistance programs, patient advocacy groups, sponsorships, charitable contributions, and similar activities
Draft and negotiate pricing, distribution (3PL, specialty distributors, specialty pharmacy providers, GPOs, PSPs), payer, and reimbursement agreements, including value-based and outcomes-based contracts, Including defining service levels for cold chain management and temperature sensitive biologics
Support government program contracting, including Medicare, Medicaid, 340B, and VHCA
Review, negotiate and draft general Master Services Agreements, Statements of Work/Purchase Orders, Amendments for the Commercial, Marketing, Market Access, and G&A functions
Develop template agreements that support the Company's commercial activities
Advise on the legal structure of limited distribution networks for specialty drugs, including exclusive provider arrangements with payors or pharmacy benefit manager (PBMs.)
Ensure all distribution practices adhere to federal and state laws, including the Drug Supply Chain Security Act (DSCSA), FDA regulations and Good Distribution Practice (GDP) standards
Partner with commercial teams to navigate complex reimbursement, prior authorization support and co-pay assistance programs for high-cost medications
Work with internal Compliance team to ensure contracts comply with Company policies and applicable law, such as False Claims Act, Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), GDPR, DOJ Bulk Data Rule, BIOSECURE Act, and state/federal transparency laws (e.g., Open Payments/Sunshine Act), especially in the context of discount safe harbors, administrative fees and rebate structures
Establish, and serve on, relevant Company committees to support Commercial/Marketing and Market Access activities
Provide legal advice for formulary placement, managed care agreements in U.S. and international markets
Monitor regulatory changes and enforcement trends in pharmaceutical commercialization and communicate timely to relevant business teams
Provide training and educational sessions for internal stakeholders on various legal topics for contracting related to commercialization of pharmaceuticals
Develop, implement, review and update policies, procedures, and controls to ensure contracting adheres to legal and regulatory requirements
Ability to identify, evaluate, and advise on risks associated with commercial transactions; as necessary, proactively provide innovative alternatives to the meet business goals while also reducing Company risk
Ensure clear and prompt communication with internal stakeholders 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

Education, Experience and Skills:

Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing
Minimum of 8+ years of major law firm and/or in-house relevant experience in a pharmaceutical company
Must have extensive independent contract negotiation and drafting experience in the pharmaceutical industry
Strong understanding of contract law and commercial regulations and industry standards
Experience supporting product launches in the pharmaceutical sector
Strong knowledge of relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting healthcare compliance laws and pharmaceutical manufacturers, focused on drug labeling, drug advertising, fraud and abuse (anti-kickback, off-label promotion), product liability, clinical trials, etc.
Precise drafting and strong legal analysis skills
Ability to communicate complex legal issues to senior management and non-legal stakeholders
Regulatory Knowledge and deep expertise in the Anti-Kickback statues , the Sunshine Act, and the Prescription Drug Marketing Act
Excellent written and oral communication skills; professional manner. Able to work effectively and efficiently with all levels of management and personnel
A keen understanding of business and practical problem solver that presents positive, creative solutions and alternatives for management
Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment
Self-starter with the ability to work independently as well as collaboratively in a team environment

The pay range for this role is $203,000-$253,000 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.