Senior Commercial Attorney

Location: Princeton NJ (OnSite)

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 Companys 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 gotomarket 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 Companys Promotional Review Committee (PRC)

• Sales and Marketing
  • Provide legal advice to fieldbased 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 AntiKickback 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 valuebased 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 valuebased and outcomesbased 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) copay assistance and hub service compliance.
• CrossFunctional Collaboration
  • Train internal stakeholders on pricing reimbursement and commercial compliance issues.
  • Monitor regulatory changes and enforcement trends in pharmaceutical commercialization.

• • Collaborate with crossfunctional 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 asneeded 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 inhouse 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 (antikickback offlabel 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 fastpaced environment and exercise sound commercial and legal judgment.
• Selfstarter with the ability to work independently as well as collaboratively in a team environment.

The pay range for this role is $230000$260000 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.