Deputy General Counsel / Vice President, Healthcare Law & Compliance
About The Position
LB Pharmaceuticals is seeking a senior leader to join its growing legal team in a strategic, high-impact role in a small-company environment. The role is intended for an experienced healthcare attorney with deep FDA regulatory and fraud and abuse expertise and a demonstrated ability to lead cross-functional legal and compliance strategy. The Deputy General Counsel / Vice President, Healthcare Law & Compliance will provide strategic legal guidance on planned commercialization activities and serve as lead counsel for healthcare regulatory matters. The position will oversee the healthcare compliance function, including building and maintaining a program that scales with company growth. It reports to the General Counsel and collaborates with executive leadership and the Clinical, Commercial, and Medical Affairs functions.
Requirements
- 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 and ability to advise clinical, medical, and commercial teams.
- Exceptional executive communication, stakeholder management, and negotiation skills, including the ability to explain 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.
- Sense of urgency.
Responsibilities
- Advise leadership team members on commercialization issues with broad enterprise impact.
- Serve as the legal representative on Commercial and Medical committees and teams, including promotional review, medical materials, and educational and charitable grants.
- Lead counsel for healthcare regulatory law, including the FDCA and related regulations and guidance; fraud and abuse laws and guidance, including the Anti-Kickback Statute, False Claims Act, and OIG guidance and advisory opinions; and federal and state transparency and reporting laws.
- Oversee the 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, investigations, and reporting processes.
- Lead 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 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
