Jobs and Careers

Senior Director, Legal

United Statesfull_timeVerifiedPosted 24 Feb 2025

💰 $326,000/yr($266,000/yr – $326,000/yr)

About the role

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 submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Senior Director, Legal will be responsible for providing proactive and strategic expert counsel on a wide array of legal issues pertaining to Ardelyx. The Senior Director will report directly to the SVP of Legal and will work closely with other Legal team members to support internal business partners including Commercial, Market Access, Technical Operations, Human Resources, Patient Advocacy, Government Affairs, Finance, IT, R&D and Compliance. The candidate will be expected to take on strategic assignments and, as Ardelyx and the Legal department scale, potentially take on a leadership role. The ideal candidate will have prior experience in the pharma or biotech sector with demonstrated experience in health care regulatory and/or market access matters. Familiarity with the following areas is strongly preferred: healthcare fraud and abuse, government price reporting, patient services, and privacy and data protection. Responsibilities:

Ensure that internal clients receive sound, practical and timely legal advice on a wide variety of legal matters related to the operation of a commercial business that markets to health care professionals
Partner with the SVP of Legal to assess the needs of the business, and to identify, scope and mitigate risks
Draft, review and negotiate various types of agreements including trade/distribution and supply (including specialty pharmacy and patient support services), commercial, corporate, and other critical business agreements
Collaborate with the Compliance team to ensure that the company’s healthcare compliance programs reflect applicable laws, rules, regulations and guidance governing drug promotion, field customer engagement and incentive compensation, financial arrangements with healthcare providers
Liaise with Government Affairs colleagues on proposed and enacted laws relating to pricing, Medicaid, Medicare, and other market access matters and issues
Provide proactive and strategic legal advice to cross-functional business partners on a wide range of legal matters including, but not limited to, patient services, privacy and data protection, AI-related matters, and employment
Provide appropriate counsel and guidance to other members of the Legal department, and serve as a mentor in order to foster the team’s professional growth and development, and support the team’s achievement of Company and/or department expectations and goals as identified by senior management
Work independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues

Qualifications:

A Juris Doctor (J.D.) from an ABA-accredited law school with 8+ years of relevant experience at a law firm and/or pharmaceutical/biotech company, with a strong preference for at least 5 years in-house with a pharmaceutical/biotech company
In-depth knowledge of commercial, compliance and regulatory matters related to the commercialization of branded pharmaceutical products
Contract drafting and negotiating experience involving complex market access, sourcing and supply, and other commercial agreements in biopharmaceuticals is required
A robust understanding of pharmaceutical business transactions and regulatory issues, relevant federal and state healthcare laws and regulations (Anti-Kickback Statute, FCPA, False Claims Act, FDA Rules) is required. Experience with market access-related regulations (Medicare, Medicaid, the 340B drug pricing program, the Affordable Care Act and the Inflation Reduction Act of 2022), employment law, privacy and data protection laws is preferred
A preferred candidate is one who wants to develop professionally by learning about new subject matters and thinking strategically