The General Counsel is a member of the Executive Team. Responsible for advising the Chief Executive Officer, members of the executive leadership team and the Board of Directors on various critical legal and business matters. The General counsel will provide legal advice on contracts, legal risks, and business terms. He/she will develop a good understanding of the Company’s operations and possess the ability to evaluate and balance both legal and business factors when providing recommendations. The successful candidate will have a broad knowledge base in areas appropriate for an experienced in-house counsel at a medical device company.
Essential Duties and Responsibilities
- Advise executives, senior management and the Board of Directors on various matters such as legal rights, and new and existing laws.
- Provide legal advice related to public company reporting and compliance, including SEC rules and regulations and NASDAQ listing standards; handling statutory filings, managing and advising on corporate governance and disclosure matters; maintain corporate records; routine counseling on corporate issues including close interaction with executive management.
- Provide expert and strategic legal advice to management regarding domestic and international commercialization, including expansion in select geographies.
- Actively participates in corporate level transactions, including identifying key issues and risks, evaluate new business partnerships with vendors and subcontractors; work closely with other members of the Company’s management team and inform and advise the Company’s Board of Directors as needed.
- A hands-on approach and attention to detail in performing various duties, including drafting, reviewing, and negotiating various agreements. Example agreements include domestic and international distribution agreements, specialized product purchase/use agreements with physicians, manufacturing/supply contracts with suppliers of materials or services, clinical trial agreements, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, and other miscellaneous contracts and corporate documents.
- Advise business managers throughout the contract negotiation process with respect to the areas of legal risk and exposure, while recommending strategies to achieve a satisfactory outcome.
- Create/modify appropriate template contracts tailored to the business needs; draft agreements that minimize risks and maximize legal rights; manage contract database.
- Ensure that the Company is compliant with its data protection obligations, including (but not limited to), requests for personal data, DSARs, privacy policies, privacy assessments and data processing agreements.
- Develop corporate governance, business and compliance policies and practices, enforce policies and regulations in all aspects and levels across the Company.
- Oversee compliance with corporate governance and the Company’s privacy compliance program, including applicable policies and procedures; participate in training of employees, including field and sales teams.
- Work closely with the various departments and provide recommendations and comprehensive legal and compliance support where required; guide interdisciplinary teams and management on regulatory issues and health care compliance and provide time and effective legal advice and risk guidance on daily activities; provide risk management and mitigation counseling.
- Advise on applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, patients, advocacy groups and other business partners, including, but not limited to compliance with Federal and state anti-kickback statutes, False Claims Act, the Food, Drug and Cosmetic Act, HIPAA and product liability law.
- Preserve all corporate records. Handle all statutory filings, such as licensing forms.
- Negotiate, draft, and implement a variety of multi-party agreements including mergers and acquisitions, strategic alliances, and joint ventures.
- Oversee the selection, retention, management, and evaluation of all outside counsel.
- Provide overall leadership and management of legal function including leading, mentoring, and developing the legal team.
Education and Experience
- J.D. degree from a national law school and strong academic credentials
- 10+ years of hands-on legal experience supporting corporate governance issues, corporate and commercial contracting activities and healthcare compliance activities, and corporate secretarial duties
- Leading law firm and/or in-house medical device/biotechnology/pharmaceutical industry experience is required
- Active member of the California State Bar or California State Bar eligibility
- Strong knowledge of contract documents and concepts and strong drafting skills, attention to details is important
- Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, patient privacy, and related issues
- Experience in strategic M&A activities.
- Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business
- Great negotiating skill, ability to prioritize, handle multiple tasks and work independently under tight deadlines
- Proven track record of delivering consistently on complex projects under challenging circumstances with a sense of urgency, but with the ability to also keep broader strategic objectives in focus
- Ability to communicate effectively both verbally and in writing in both individual and group settings
- Ability to work calmly under pressure, manage a significant number of projects simultaneously and to thrive in a dynamic and fast paced environment
Skills, Abilities, and Other Requirements
- Proficient knowledge and skill in Microsoft Office Suite applications.
- Excellent oral written communication skills and critical thinking skills.
- Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
- Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
- Ability to lift 10-15 pounds.