VP, Associate General Counsel, Healthcare Compliance and Privacy Officer

About the position We’re looking for a thoughtful, collaborative, pragmatic, and experienced attorney to help support the company as it expands its commercial footprint in domestic and international markets. Reporting to Karius’s Chief Legal Officer, the preferred candidate will primarily serve as the senior legal advisor to the executive and commercial leadership teams on legal, healthcare compliance, and privacy matters related to the Company’s commercialization strategies, tactics, and operations. The right individual will thrive in a fast-paced, entrepreneurial environment and exhibit uncompromising ethics, excellent communication and influencing skills, as well as sound judgment to effectively balance risk mitigation and achievement of business objectives.

Responsibilities

• Advise the Company and Commercial Leadership team on legal issues related to product development, scientific exchange, pricing, market access, strategic partnerships, and sales and marketing strategies and tactics to mitigate legal risk as the business scales in domestic and international markets.
• Oversee the development, implementation, and documentation of Karius’s healthcare compliance and privacy programs, including identifying areas of risk, developing policies and procedures, deploying appropriate training, conducting periodic monitoring, auditing, and investigations, implementing necessary corrective action programs, providing routine updates to the Company’s Leadership regarding healthcare compliance matters, in collaboration with cross-functional partners.
• Partner in the development and review of externally facing communications, including marketing materials, press releases, social media engagements, field sales customer engagements (speaker bureaus, launch tactics, pricing discussions), market access materials, medical affairs customer engagement (KOL interactions, publications, advisory boards, medical education, investigator-initiated grants, research collaborations).
• Collaborate with cross-functional partners on the development of communications and responses to healthcare regulatory authorities, related to the Company’s commercial activities, privacy, and healthcare compliance matters.
• Advise and develop compensation plans and policies regarding field sales, and customer targeting.
• Maintain current knowledge of applicable federal and state laws related to the commercialization of diagnostics and operations of healthcare compliance and privacy compliance programs and provide cross-functional education to inform strategic decision-making and mitigate operational legal and compliance risk.
• Advise regarding healthcare regulatory, privacy, and compliance concerns related to various company activities, including financings, joint ventures, clinical research agreements, and commercial collaborations.
• Collaborate with legal team members to support contracting matters for commercial, medical affairs, and business development.

Requirements

• JD or L.L.M. from an accredited law school in the United States.
• Bar admission and active membership in a US state, CA required.
• 10+ years of relevant industry or law firm experience with at least 8 years as in-house counsel supporting commercial products for a biotech or preferably, a diagnostics company.
• Proven ability to lead teams and achieve challenging objectives with direct and indirect management of functional internal and external resources.
• Substantive experience advising regarding fraud and abuse (AKS, Stark, FCA, EKRA, CMPL, FCPA), regulatory (FDCA, corporate practice of medicine), privacy (HIPAA, GDPR, CCPA), and unfair trade practices/anti-trust laws and regulations.
• Proven ability to support product launches.
• Demonstrated skill in developing strategic vision, performing informed risk assessments, and operational implementation of effective policies and procedures across multi-functional teams and business units.
• Experience building and leading Healthcare Compliance Program in a growth-stage corporate environment requiring strategic deployment of resources to mitigate risk and appropriately scale with business.
• Experience in a growth-stage company collaborating with the Chief Legal Officer on building the legal function, including managing budgets, identifying appropriate outside counsel resources, deploying technology solutions, and advising regarding staffing.
• Strong oral and written communication skills with an ability to communicate effectively to, and advise, the Karius Leadership Team.
• Ability to effectively collaborate with peers and team members in other functions.
• Ability to identify risk, define problems, gather data, establish facts, and draw valid conclusions and recommendations.
• Adaptability and flexibility to changing priorities, demonstrating strong people and project management skills.
• Strong business acumen and use of business analytics to prioritize, lead, and influence.
• Strong attention to detail, and being comfortable making decisions amid ambiguity
• Excellent analytical and abstract reasoning skills.

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