About Karius
Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed. Combining next-generation sequencing and proprietary data analysis we can identify over 1000 pathogens from a single blood sample with a typical turnaround time of one business day. By unlocking the information present in microbial cell-free DNA were helping doctors quickly solve their most challenging cases with a future vision of accelerating clinical trials discovering new microbes and reducing patient suffering worldwide.
Position Summary
Were 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 Kariuss 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 Companys 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.
Why Should You Join Us
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The Companys platform is already delivering unprecedented insights into the microbial landscape providing clinicians with a comprehensive test capable of identifying more than 1000 pathogens directly from blood and helping industry accelerate the development of therapeutic solutions. The Karius Spectrum TestTM we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of incredible work done by our scientists statisticians engineers and physicians all driven by the same mission. You as part of the Karius team will be able to see how your work directly has a life-changing impact on people and at scale.
Reports to: Chief Legal Officer
Location: Redwood City CA (Hybrid) or Remote (USA)
Primary 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 Kariuss 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 Companys 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 Companys 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.
Whats Fun About the Job
Karius is operating at the leading edge of what is now known to be possible in infectious disease diagnostics. With that comes a wave of new and incredible challenges and opportunities. To deliver on that value you will be tapping into some of the most advanced technologies architecting and innovating where the current solutions simply dont suffice. You will get to see how much your work really matters.
Travel: Required up to 20%
Physical Requirements
Subject to extended periods of sitting and/or standing vision to monitor and moderate noise levels. Work is generally performed in an office environment.
Position 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.
Personal Qualifications
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.
Disclaimer
The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties responsibilities and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.
Equal Opportunity Employer
At Karius we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people in our hiring recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individuals race color sex gender identity and gender expression (including transgender individuals who are transitioning have transitioned or are perceived to be transitioning to the gender with which they identify) religion age national origin or ancestry citizenship physical or mental disability medical condition family care status marital status domestic partner status sexual orientation genetic information military or veteran status or any other basis protected by federal state or local laws. If you are unable to submit your application due to a disability please contact us at emailprotected and we will accommodate qualified individuals with disabilities.