Job Description

Overview Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Kardigan’s mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. The company is led by co-founders who previously led MyoKardia to discover and develop mavacamten, resulting in an acquisition by Bristol Myers Squibb in 2020. Kardigan has a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patients’ lives. Our values guide how we work, interact, and achieve our goals, including a patient-first mindset, authenticity, eagerness to learn, teamwork, and enabling the impossible because patients are counting on us. Position Title: Director, Healthcare and Compliance Department: Legal Reports To: Vice President, Corporate Law Location: Princeton, NJ or South San Francisco, CA – On-site 4 days per week (Mon to Thurs) Responsibilities Provide legal guidance on compliance with healthcare regulations including Medicare/Medicaid requirements and other healthcare regulatory laws, such as Anti-Kickback Statute, Stark Law, Sunshine Act, state fraud and abuse laws, corporate practice of medicine and fee-splitting prohibitions. Develop and implement healthcare compliance policies, procedures, and programs. Support or participate in healthcare compliance committees and oversee compliance auditing. Lead compliance monitoring activities, conduct regular risk assessments, and implement corrective action plans as needed. Advise on healthcare compliance matters related to pharmaceuticals, medical devices, physician practices/remote patient monitoring, and other digital health products as applicable. Provide legal guidance on patient rights, informed consent, and medical ethics issues. Support healthcare transactions and business arrangements with regulatory analysis as applicable. Monitor and analyze emerging healthcare legislation and regulatory changes. Interact with local counsel in foreign jurisdictions to ensure compliance with local healthcare laws. Privacy & Data Protection: support privacy compliance across the organization (HIPAA, GDPR, CCPA/CPRA and other applicable privacy laws); advise on privacy requirements for cross-border transfers, clinical operations, and new products; review data collection, storage, processing activities, PIAs, and DPAs; manage privacy incident response and breach notification; collaborate with IT and security teams on data protection measures. Contract Management: draft, review and negotiate agreements (data sharing/transfer agreements, master services agreements, consulting agreements, and other commercial agreements); develop contract templates and playbooks; provide strategic guidance on contract terms and risk allocation. Qualifications JD degree from an accredited law school with admission to practice law. Minimum of 7 years of legal experience with mix of law firm and in-house experience at pharmaceutical, biotechnology, or medical device companies. Strong expertise in healthcare regulations and data/privacy laws for pharmaceuticals, devices, and digital health products. Experience with FDA regulations and regulatory framework in foreign jurisdictions. Working understanding of HIPAA, GDPR, and other privacy frameworks. Contract drafting, review and negotiation skills. Excellent problem-solving, organizational and planning skills; ability to manage changing priorities and multiple projects. Strong interpersonal, written and verbal communication skills; ability to collaborate with stakeholders at all levels. Ability to operate in a fast-paced, rapidly growing workplace; able to work independently with initiative and good judgment. Motivated and enthusiastic; willing to support special projects and initiatives. Understand and support a patient-first mentality. Compensation : Exact compensation may vary based on skills, experience and location. Pay range: $227,000 - $309,000 USD Apply Interested in building your career at Kardigan? Please apply through Kardigan Careers or the company’s official application channel. #J-18808-Ljbffr Kardigan, Inc.

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