Commercial Legal Counsel

Ardelyx • Waltham, MA

11h • Onsite

About The Position

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Commercial Legal Counsel will be responsible for providing tactical legal support and sound counsel on a wide array of legal issues pertaining to Ardelyx. The Commercial Legal Counsel will report to the Senior Director of Legal and will work closely with other Legal team members to support internal business partners including Commercial, Market Access, Patient Advocacy, and Medical Affairs. The candidate will be expected to effectively manage a high volume of operational legal matters and, as Ardelyx and the Legal department scale, grow their professional expertise within the organization.

Requirements

• A Juris Doctor (J.D.) from an ABA-accredited law school with 3-5 years of relevant experience at a law firm and/or pharmaceutical/biotech company.
• Strong foundational knowledge of commercial, compliance and regulatory matters related to the commercialization of branded pharmaceutical products
• Proven experience in contract drafting and negotiating, specifically involving market access, sourcing, complex commercial agreements in biopharmaceuticals, and HCP-related agreements
• A solid understanding of relevant federal and state healthcare laws (Anti-Kickback Statute, False Claims Act, FDA Rules, Sunshine Act)
• Excellent interpersonal, written and verbal communications skills, with the ability to explain legal concepts to non-attorneys
• Strong organizational skills with a "roll up your sleeves" approach to managing high-volume contract cycles and compliance workflows in a fast-paced environment
• A collaborative style and an ability to work effectively within a cross-functional team
• Business pragmatism and the ability to apply legal requirements to practical business solutions
• Ability to travel periodically as needed

Nice To Haves

• Experience or interest in market access-related regulations (Medicare, Medicaid, 340B)

Responsibilities

• Provide day-to-day sound, practical and timely legal advice to internal clients on matters related to the operation of a commercial business
• Provide operational legal advice to cross-functional business partners on matters including, but not limited to, patient services, market access and HCP interaction
• Contribute to special legal projects and strategic initiatives in areas outside of the core commercial function to support broader business objectives.
• Support senior Legal leadership to assess business needs and assist in the identification and mitigation of legal risks
• Draft, review and negotiate a variety of agreements including trade/distribution, supply, specialty pharmacy, patient support services, and other commercial agreements
• Draft, review, and negotiate HCP-related agreements, including consulting, speaker bureau, and advisory board agreements, ensuring compliance with internal policies
• Collaborate with the Compliance team in ensuring that the company’s healthcare compliance programs reflect applicable laws and regulations governing drug promotion, field customer engagement, and financial arrangements with healthcare providers and associated transparency reporting
• Liaise with Commercial and Medical Affairs teams to provide legal oversight on HCP engagement workflows and associated documentation
• Manage independent legal projects and contribute to the development of legal processes and templates to improve departmental efficiency
• Collaborate with other departments in developing and presenting training materials on various legal issues

Benefits

• 401(k) plan with generous employer match
• 12 weeks of paid parental leave
• up to 12 weeks of living organ and bone marrow leave
• equity incentive plans
• health plans (medical, prescription drug, dental, and vision)
• life insurance and disability
• flexible time off
• annual Winter Holiday shut down
• at least 11 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees