Job Summary:

Reporting to the Chief Legal Officer, the Senior Counsel will be a key member of Legal Affairs and will assist in global legal matters including healthcare regulatory, corporate governance, M&A, data privacy & security, intellectual property, marketing/sales, employment / HR matters and other general legal matters. The Associate General Counsel will be involved in strategic and tactical legal initiatives, advise management on legal issues and implications, assist in managing and overseeing outside counsel, assist in managing the company’s patent portfolio and manage a high volume of contracts. This role has a high degree of interaction with management and offers the potential for expansion of duties and the opportunity to make a significant impact on the Company's continued growth.

Supervisory Responsibilities:

· The Senior Counsel will supervise junior staff and interns.

Duties/Responsibilities:

· Provide practical counsel to corporate development, operations, regulatory, commercial, clinical, R&D, marketing, sales and HR teams on legal issues.

· Strong knowledge of global healthcare regulations and industry guidelines applicable to medical devices and commercial clinical laboratories, including FDA, CLIA, HIPAA, CCPA, GDPR, fraud & abuse laws (including False Claims Act, Anti-Kickback Statue, Physicians Self-Referral Laws), healthcare reimbursement and Sunshine Act requirements.

· Experience managing intellectual property filings, including patent and trademark applications prepared by outside counsel and working with scientific and marketing teams to strengthen applications and appeal rulings.

· Draft, review and negotiate a wide range of contracts, including commercial contacts, venture and other financing agreements, real estate leases, employment-related agreements, clinical study-related agreements, service agreements, consulting agreements, vendor agreements, and non-disclosure agreements and advise on contact status and legal risks and liabilities.

· Participate in and assist with all aspects of the Company's M&A, collaboration and joint venture transactions, including preparation of letters of intent and term sheets, due diligence, deal document review and negotiation, and handling legal and operational tasks post-closing.

· Advise on risk management and mitigation (e.g., information privacy and security, intellectual property rights and obligations, and insurance coverage issues).

· Support the development of policies, training materials, forms, processes and templates on industry-specific issues.

Required Skills/Abilities:

· Ability to communicate effectively across business units

· Practical and logical thinker with a commercial focus and ability to deliver risk assessment to business units for their ultimate decision

· Ability to efficiently manage a high-volume of work on tight deadlines with limited supervision

· Ability to quickly integrate legal, business and pragmatic analysis

· Ability to function well in a high-paced and at times stressful environment

· Team-oriented, low-ego with an excellent sense of humor

· Excellent oral and written communication and project management skills

· Excellent organizational skills and attention to detail.

· Strong analytical and problem-solving skills.

Education and Experience:

· A JD and member of a state bar in good standing, with ability to register as In-house Counsel

· At least 5-7 years of broad corporate and healthcare law experience practicing in a mix of large firms and in house – public company and diagnostics experience preferred

· Experience drafting a variety of R&D and commercial agreements

· Experience researching and advising on complex healthcare and corporate matters to minimize business risk

Working Conditions and Physical Effort:

· Work is normally performed in a typical interior/office work environment

· Prolonged periods of sitting at a desk and working on a computer.

· Limited exposure to physical risk

· Limited physical effort required