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
This is the pay for this position
Pay Transparency
$217,000-$271,000 USD
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 [redacted] to obtain prior written authorization before referring any candidates to Summit.
