VP, Associate General Counsel, Healthcare Compliance and Privacy Officer jobs in United States
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Karius · 14 hours ago

VP, Associate General Counsel, Healthcare Compliance and Privacy Officer

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed. They are seeking an experienced attorney to serve as the senior legal advisor on healthcare compliance and privacy matters as the company expands its commercial footprint.

BiotechnologyGeneticsHealth CareInformation TechnologyLife SciencePrecision Medicine

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

Qualification

JDL.L.M.Bar admissionHealthcare compliance experiencePrivacy law knowledgeFraudAbuse regulationsProduct launch supportAnalytical skillsCommunication skillsCollaboration skillsAttention to detail

Required

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

Company

Karius

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Karius delivers genomic insights into infectious diseases, helping clinicians make critical, life-saving treatment decisions.

Funding

Current Stage
Growth Stage
Total Funding
$354M
Key Investors
SoftBank Vision FundOxford Finance LLCDCVC
2024-05-02Series C· $100M
2020-02-24Series B· $165M
2018-11-30Debt Financing· $25M

Leadership Team

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Alexander Ford
Chief Executive Officer
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Tim Blauwkamp
Chief Scientific Officer, Co-founder
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Company data provided by crunchbase