Senior Commercial Attorney

Location: Princeton, NJ (On-Site)

Overview of Role:

The Senior Commercial Attorney provides legal expertise and support to Summit Therapeutics (the Company) on product marketing, promotional, commercial, and pricing/compliance matters. This position reports directly to the VP, Head of Legal and partners with commercial, marketing, market access, finance, clinical, manufacturing and other internal departments to protect the Company from risk, support Company business objectives, and ensure compliance with Company guidelines.

Role and Responsibilities:

• Commercial/Product Launch
  • Provide legal advice and guidance on all aspects of the Company's commercial activities, including product launches, promotional materials, medical education programs, advisory boards, speaker bureaus, research grants, patient assistance programs, patient advocacy groups, foundation grants, sponsorships, charitable contributions, corporate giving, and similar activities.
  • Provide legal guidance on go-to-market strategies, including distribution models, payer coverage, and pricing frameworks.
  • Review promotional materials, marketing campaigns, and patient engagement programs to ensure regulatory compliance.
  • Advise on interactions with healthcare professionals (HCPs), patient advocacy groups, and payer organizations, including speaker programs, advisory boards, and medical education initiatives.
  • Ensure compliance with all laws and industry guidelines on advertising, promotion, and product labeling.
  • Serve as the Legal representative on the Company's Promotional Review Committee (PRC)

• Sales and Marketing
  • Provide legal advice to field-based teams, including sales, reimbursement, and market access personnel.
  • Advise on sales team trainings, incentive compensation programs, and risk mitigation strategies.
  • Work with Compliance team to ensure Company compliance with False Claims Act, Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), and state/federal transparency laws (e.g., Open Payments/Sunshine Act).
  • Support medical communications, disease awareness campaigns, and marketing initiatives.
• Pricing, Market Access & Reimbursement
  • Provide legal guidance on pricing strategies, contracting, and compliance with government price reporting requirements, including Medicaid and Medicare, 340B Drug Pricing Program, and the Inflation Reduction Act (IRA).
  • Advise on payer negotiations, value-based agreements, and commercial insurance reimbursement strategies.
  • Support government price reporting compliance and calculations; provide legal risk assessments for government pricing and contracting initiatives.
  • Advise on state drug price transparency laws and compliance with Medicaid rebate programs and price concessions reporting.
  • Provide legal support for formulary placement, managed care agreements in U.S. and international markets.
  • Draft, negotiate, and review pricing, distribution, payer, and reimbursement agreements, including value-based and outcomes-based contracts.
  • Manage legal aspects of patient support programs, reimbursement hubs, and pharmacy benefit manager (PBM) agreements.
  • Advise on manufacturer coupon programs, patient assistance programs (PAPs), co-pay assistance, and hub service compliance.
• Cross-Functional Collaboration
  • Train internal stakeholders on pricing, reimbursement, and commercial compliance issues.
  • Monitor regulatory changes and enforcement trends in pharmaceutical commercialization.

• • Collaborate with cross-functional teams on new product development, lifecycle management, and marketing support of pharmaceutical products.
  • Provide training and educational sessions for internal stakeholders on various legal topics related to the commercialization of pharmaceuticals.
  • Develop and implement policies, procedures, and controls to ensure adherence to legal and regulatory requirements.
  • Timely identify risks and issues; as necessary, proactively provide alternatives to the business teams that meet Company business objectives 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.

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 experience.
• Experience supporting product launches in the life sciences industry is required, with a strong preference for experience in the pharmaceutical sector.

• Strong knowledge of relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting 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
• 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 $230,000-$260,000 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.

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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.