Associate Director, Legal Counsel

Ardelyx•Waltham, MA

3d•Hybrid

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. The Associate Director, Legal Counsel will be responsible for providing tactical legal support and sound counsel on a wide array of legal issues pertaining to Ardelyx. This role 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. This position is hybrid-based (2-3 days) out of our Waltham, MA office.

Requirements

A Juris Doctor (J.D.) from an ABA-accredited law school with 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

Nice To Haves

Experience or interest in market access-related regulations (Medicare, Medicaid, 340B)
Ability to travel periodically as needed

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 as the legal business partner 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