Executive Director, Compliance
Vera Therapeutics
- Brisbane, CA
- Permanent
- Full-time
- Develop, execute, and oversee Vera’s Compliance Program, in partnership with Vera Legal, including drafting relevant policies and procedures.
- Develop and deliver compliance training to employees, ensuring understanding of industry-specific compliance risks and regulatory obligations.
- Monitor evolving federal and state compliance developments that may impact business operations and product launches, and update company compliance policies and procedures, as necessary.
- Provide strategic guidance on emerging healthcare compliance risks, including clinical trials, patient support programs, expanded access programs, and commercialization strategies.
- Partner with key stakeholders to develop policies and procedures for all relevant transfers of value to HCPs/HCOs (e.g., FMV, Sunshine Act Reporting, etc.) and ensure compliance with relevant regulatory requirements (including reporting, tracking, identifying, and reconciling payments) and Vera policies.
- Ensure compliance with state transparency reporting laws (i.e. gift, meals, and/or other transfers of value) in partnership with relevant business stakeholders.
- Develop policies/processes to identify, investigate, and resolve compliance issues/concerns within the company as well as potential areas of compliance vulnerability and risk; work collaboratively with the relevant business function(s) to implement corrective action plans for resolution of problematic issues; and provide guidance on how to prevent or address similar situations in the future.
- Provide compliance expertise for global healthcare-related initiatives, as may be required.
- Manage external compliance vendors.
- Lead Vera’s Corporate Compliance Committee.
- Serve as the primary compliance advisor to cross-functional team members, including commercial, medical affairs, and other functions, as necessary, and to align compliance strategy with business objectives.
- Ability to be flexible and adapt with a growth mindset while providing practical compliance solutions to complex challenges.
- Effectively partner and collaborate with Legal stakeholders, as may be required by the Compliance role.
- Other responsibilities and tasks, as may be reasonably required, to advance Legal/Compliance department objectives and goals.
- JD (Juris Doctor) from an accredited law school and admission to practice law in at least one relevant jurisdiction is strongly preferred.
- Minimum of10-12 years of directly relevant compliance experience in the biotech, pharmaceutical, or life sciences industry.
- Strong knowledge of U.S. and global healthcare compliance regulations, including OIG elements, compliance with AKS/FCA, PhRMA Code, Sunshine Act Reporting, FCPA, HIPAA, etc.; additional experience with relevant ex-US laws and regulations is preferred.
- Experience with FMV assessments, Transfer of Value reporting, price transparency regulations, and industry compliance best practices.
- Experience designing healthcare compliance programs and delivering related training programs.
- Excellent communication, analytical, and relationship-building skills with proven ability to work independently and cross-functionally.
- Ability to commute to the Brisbane office at least one day a week is preferred, although qualified remote candidates will be considered.