Deputy General Counsel / Vice President, Healthcare Law & Compliance
We are looking to add a senior leader to our growing legal team. This is a strategic, high-impact role in a small-company environment. It is designed for an experienced healthcare attorney with deep FDA regulatory and fraud and abuse expertise with proven ability to lead cross-functional legal and compliance strategy.
The Deputy General Counsel / Vice President, Healthcare Law & Compliance will provide strategic legal guidance on the company's planned commercialization activities and serve as lead counsel for healthcare regulatory matters. This role will also oversee the company's compliance function, including building and maintaining a compliance program that scales with our growth. This role will report to our General Counsel and collaborate cross-functionally with executive leadership, Clinical, Commercial, and Medical Affairs.
Responsibilities
- Advise members of the leadership team on a wide range of commercialization issues with broad enterprise impact.
- Serve as legal representative on Commercial and Medical committees and teams, including promotional review, medical materials, and educational and charitable grants.
- Serve as lead counsel for healthcare regulatory law, including the FDCA and related regulations and guidance documents, fraud and abuse laws and guidance (Anti-Kickback Statute, False Claims Act, OIG guidance and advisory opinions), and federal and state transparency and reporting laws.
- Oversee the company's healthcare compliance function and build, implement, and maintain a healthcare compliance program consistent with industry best practices.
- Develop and maintain healthcare compliance policies, procedures, and controls, including those governing promotional materials, scientific exchange, and interactions with healthcare professionals and patients.
- Oversee healthcare compliance training, auditing and monitoring, risk assessments, and investigations, and reporting processes.
- Lead the company's federal and state transparency and aggregate spend reporting.
- Provide strategic legal advice on patient support programs, patient hubs, and market access, and oversee commercial contracting.
- Monitor emerging healthcare regulatory and healthcare compliance trends, and assess and communicate their impact on the company.
- Build and manage a high-performing healthcare law and compliance team in a dynamic, high-growth environment.
Required Qualifications
- JD degree.
- Active membership in good standing with a State Bar.
- 15+ years of legal experience, including leadership experience at a commercial-stage biotech or pharmaceutical company.
- Demonstrated experience building, leading, or overseeing a healthcare compliance program.
- Deep familiarity with FDA advertising and promotion compliance.
- Experience supporting product launches.
- Strong contracting acumen; ability to advise clinical, medical, and commercial teams.
- Exceptional executive communication, stakeholder management, and negotiation skills; ability to convey complex legal risks in clear, business-centric terms.
- Experience hiring and developing legal and healthcare compliance teams.
- Collaborative, flexible, and pragmatic work style, with excellent interpersonal skills that build trust and alignment across functions.
- Ability to maintain confidentiality and operate with the highest ethical standards and professionalism.
- Sence of urgency
The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $350,000-$390,000
