Director, Healthcare and Compliance (Princeton, NJ) chez Kardigan

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) 

Job Overview 

Kardigan is seeking an experienced Director, Healthcare and Compliance. This will be a strategic legal role responsible for providing comprehensive legal guidance on healthcare regulations and regulatory compliance, with additional responsibilities in privacy and contract management. This person will serve as a key legal advisor primarily focused on helping business leaders navigate complex regulatory landscapes while supporting secondary areas of privacy compliance and contract review. 

This position reports to the Vice President of Corporate Law, based in South San Francisco, CA. The role has one opening and may be located in either our Princeton, NJ office or our South San Francisco, CA office.

Essential Duties and Responsibilities 

Healthcare Compliance 

• Provide legal guidance on compliance with healthcare regulations including Medicare/Medicaid requirements and other healthcare regulatory laws, including Anti-Kickback Statute, Stark Law, Sunshine Act, comparable state fraud and abuse laws, and other state healthcare laws, including corporate practice of medicine and fee splitting prohibitions. 

• Develop and implement healthcare compliance policies, procedures, and programs. 

• Support or participate in compliance 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 jurisdiction to ensure compliance with local healthcare laws. 

Privacy & Data Protection 

• Support privacy compliance across the organization, including HIPAA, GDPR, CCPA/CPRA and other applicable US and foreign privacy laws. 

• Advise on privacy and data protection requirements, including, as applicable for cross border transfers, clinical operations, new products and services. 

• Review and approve data collection, storage, and processing activities, privacy impact assessments, and data protection agreements. 

• Manage privacy incident response and breach notification processes. 

• Collaborate with IT and security teams on data protection measures. 

Contract Management 

• Draft, review and negotiate agreements, including data sharing and transfer agreements, master services agreements, consulting agreements, and other commercial agreements. 

• Develop and maintain contract templates and playbooks. 

• Provide strategic guidance on contract terms and risk allocation. 

Qualifications and Preferred Skills 

• JD degree from an accredited law school with admission to practice law. 

• A minimum of 7 years of legal experience with a 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 capabilities. 

• Strong organizational and planning skills, ability to manage changing priorities and workflow, and the ability to effectively advance multiple simultaneous projects. 

• Strong interpersonal and written and verbal communication skills, with an ability to communicate and collaborate with individuals at all levels inside and outside of the organization in a positive and effective manner. 

• Ability to operate in a fast-paced, rapidly growing workplace, with a keen interest in providing a consistently high level of service. 

• Able to work independently while exercising initiative and good judgment. 

• Motivated and enthusiastic. 

• Assist and support with any special projects and initiatives. 

• Perform other duties as directed by the manager. 

• Understand and supports a “patient-first” mentality.