Senior Counsel, Privacy & Healthcare Regulatory

About SmithRx

SmithRx is a rapidly growing, venture-backed Health-Tech company.  Their mission is to disrupt the expensive and inefficient Pharmacy Benefit Management (PBM) sector by building a next-generation drug acquisition platform driven by cutting-edge technology, innovative cost-saving tools, and best-in-class customer service.  With hundreds of thousands of members onboarded since 2016, SmithRx has a solution that is resonating with clients all across the country.

SmithRX prides itself on its mission-driven and collaborative culture that inspires its employees to do their best work. They believe that the U.S healthcare system needs transformation, and they come to work each day dedicated to making that change a reality. At their core, they are guided by their company values of:

• Integrity: Our purpose guides our actions and gives us confidence in the path ahead. With unwavering honesty and dependability, we embrace the pressure of challenging the old and exemplify ethical leadership to create the new.
• Courage: We face continuous challenges with grit and resilience. We embrace the discomfort of the unknown by balancing autonomy with empathy, and ownership with vulnerability. We boldly challenge the status quo to keep moving forward—always.
• Together: The success of SmithRx reflects the strength of our partnerships and the commitment of our team. Our shared values bind us together and make us one. When one falls, we all fall; when one rises, we all rise.

The Role

SmithRx is looking for a Senior Counsel, Privacy & Healthcare Regulatory, who will be responsible for privacy, healthcare regulatory, and compliance issues impacting SmithRx. Reporting to the General Counsel, this candidate will be responsible for all strategic and day-to-day privacy matters for the company. You will help ensure SmithRx maintains strong privacy and data protection practices, including the responsible handling of sensitive health information in alignment with applicable privacy laws and internal policies. You will also review and analyze applicable federal and state laws and regulations in order to provide corporate compliance and risk mitigation guidance to various functions in the company, including the Product and Engineering team, Clinical Strategy team, and Customer Success team. You will oversee SmithRx’s relationships with various administrative agencies and regulators, including responding to regulatory inquiries. You will also assess and provide guidance from a healthcare regulatory standpoint for new products, services, and strategies to ensure that SmithRx’s innovative pathways to reduce drug costs are in compliance with applicable law and properly captured in commercial agreements. You will have the opportunity to work on other legal matters as needed as part of a lean, efficient legal organization.

The successful candidate will have a passion for impacting the U.S. healthcare ecosystem and is excited for the challenge of helping build the legal function at a high-growth healthcare technology company.

Responsibilities

• Collaborate with, and provide strategic and legal advice to, various cross-functional teams, including the Product and Engineering, Clinical Strategy, and Customer Success teams
• Provide tailored advice on privacy and data protection laws and emerging AI regulatory frameworks, bearing in mind privacy by design and privacy by default principles.
• Advise on all aspects of US healthcare privacy laws and regulations, including HIPAA and HITECH.
• Oversee SmithRx’s regulatory compliance posture with various government regulatory agencies, including handling periodic required regulatory filings and responding to regulatory inquiries as necessary
• Review, analyze, and advise business leaders regarding new and existing federal and state laws and regulations applicable to SmithRx’s products and services
• Work with the Product, Engineering, and Clinical Strategy teams to develop new products and services to deliver cost savings to SmithRx’s clients
• Work with the Revenue team and Commercial Counsel to draft contracts in accordance with regulatory requirements
• Ensure that SmithRx’s business functions, including its clinical review function, maintain compliance with applicable laws and regulations in various jurisdictions.
• Draft and revise internal policies and guidance for the business relating to compliance with applicable healthcare and privacy laws and regulations
• Collaborate with and supervise outside healthcare counsel
• Effectively prioritize and manage additional ad-hoc requests and responsibilities across a spectrum of complex business, legal, and strategic issues

Requirements

• J.D. degree and membership in at least one state bar
• At least six years of experience as a practicing attorney at a law firm and/or in-house
• Substantive previous experience with HIPAA and healthcare privacy laws.  
• Relevant experience and strong foundation in the healthcare legal/regulatory frameworks, ideally those affecting the pharmaceutical industry and PBMs, including working knowledge of HIPAA, PBM/TPA licensing, anti-kickback statutes, utilization review laws, pharmacy laws, and ERISA
• Experience interacting with government administrative agencies and regulators
• Strong written and oral communication skills to effectively collaborate and negotiate with internal stakeholders and external counterparties
• Highly analytical and solutions-focused with sound business judgment
• Quick learner who can adapt to a fast-paced, high-growth environment and can navigate complex cross-functional situations
• Works well under pressure, with regular prioritization and timely and transparent communication
• Comfortable operating with a high degree of autonomy
• Has an interest and passion for improving access to convenient and affordable healthcare

Bonus points:

• At least two years of experience at a top-tier law firm
• In-house counsel experience
• Experience advising (as either in-house or outside counsel), and/or contracting with PBMs, pharmaceutical manufacturers, and/or pharmacies
• Located in the Bay Area would be a plus.

Compensation:

• The salary range for this position is $240,000 – $280,000 per year, plus bonus, equity, and a competitive benefits package. A candidate’s salary is determined by various factors, including, but not limited to, relevant work experience, skills, certifications, and location.

Location

• San Francisco, California, or Remote

SmithRx has exclusively engaged Kerwin Associates to conduct this search. Any resumes sent directly to SmithRx will be forwarded to Kerwin Associates. If interested in this role, please contact Anne Kerwin Payne (anne@kerwin.com) and Spencer Britschgi (spencer@kerwin.com) at Kerwin Associates.