Executive Director, Compliance

Title: Executive Director, Compliance

Location: Brisbane, California or Remote

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

The Executive Director, Compliance will report to the report to the SVP, Legal, Healthcare/Commercial Law, Compliance, & Operations with dotted-line reporting directly to the CLO. This role will serve as the key Compliance representative to the company, overseeing and evolving Vera’s Healthcare Compliance Program.

Responsibilities:

Training & Policy Development

• 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.

Compliance Program Oversight

• 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.

Leadership & Stakeholder Engagement

• 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.

Qualifications:

• 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.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $ - $. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.

Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.

Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.