New

Senior Director, Legal

Ardelyx
life insurance, parental leave, paid holidays, flex time, 401(k)
United States, Massachusetts, Waltham
Feb 25, 2025
Description 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 Exceptional interpersonal, written and verbal communications skills, including the ability to communicate complex issues and concepts clearly and concisely to non-attorneys and influence across a cross-functional matrix organization Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems Strong sense of accountability and ownership, highly collaborative with the ability to independently and effectively manage a substantial workload in a fast-paced, rapidly evolving environment Ability to travel periodically as needed Ardelyx is also looking for the right fit for its legal team and the Company, which means the successful candidate must also have: a passion for performing work that impacts patients' lives an eagerness to help create a meaningful place for colleagues to work and grow the highest integrity and sound judgment sophisticated emotional intelligence, strong interpersonal skills, a collaborative style and an ability to exert "soft influence" and build consensus a proficiency to manage differing opinions, ambiguity and conflict effectively and to escalate issues appropriately business pragmatism and an appreciation for and comfort with appropriate and intentional risk-taking confidence navigating a highly regulated, intellectual property-intensive, public company environment excellent oral and written communication and presentation skills an innate and unshakable sense of ownership, and an open willingness to roll up your sleeves and be an everyday hands-on contributor a serious passion, curiosity, receptiveness and capacity to learn about the Company, its complex and evolving businesses and industry, the underlying clinical use of its products, and the sale, delivery and use of its products within the healthcare system Work Environment: Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $266,000 - $326,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 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, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.