Executive Director, Healthcare Legal

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 fusion protein self-administered at home as a subcutaneous once 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 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, Healthcare Legal will report to the report to the SVP, Legal, Healthcare/Commercial Law, Compliance, & Operations. This role will serve as the primary healthcare attorney for Vera’s Commercial functions.

Responsibilities:

Advising the Commercial Function:

• Extensive experience serving as the primary legal advisor to commercial team members and partner with commercial teams on business strategies and risk mitigation, particularly during launch.
• Proven ability to influence Marketing, Market Access, and Sales at both a strategic and tactical level by identifying and clearly communicating risks associated with complex business activities.
• Extensive experience advising market access clients on discount, rebate/price concession strategies, government pricing, copay/patient assistance programs, policy development, risk mitigation, and interactions with payers/HCPs/HCOs.
• Experience with reviewing and negotiating commercial and market access-related agreements, including: HCP/HCO services agreements, PBM agreements, Specialty Pharmacy agreements, discount and rebate agreements, distribution agreements, and market research agreements.
• Extensive experience advising on promotional review committees for marketing, market access, and patient support materials and assets.
• Assist with investigations and resolutions of compliance issues, including responding to challenges from competitors, governmental agencies, or other regulatory authorities regarding product claims, comparative advertising, and other healthcare-related matters.
• Work with business, legal, and compliance colleagues to assist with adherence to Vera’s policies, including provision of training to clients on applicable legal issues.
• Provide value-added legal and business insight to evaluate and mitigate risks effectively.

Legal Leadership Engagement

• Collaborate and confer with other Legal and Compliance colleagues to provide holistic legal support to the organization.
• Ability to be flexible and adapt with a growth mindset while providing practical solutions to complex legal challenges.
• Keeping abreast of changes in healthcare policies, laws, regulations and guidance and advise on necessary actions, in response.
• This role requires a high level of good and balanced judgment, including but not limited to internal escalation decisions, and an ability to independently discern and establish priorities. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are highly valued.
• This role may routinely collaborate with senior leadership and is intended for someone with little need for frequent, immediate supervision.
• 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 California (CA RIHC license is acceptable), if required.
• Minimum of 10-12 years of directly relevant healthcare law experience in the bio-pharmaceutical industry; in-house experience launching a commercial drug (or line extension) is strongly preferred.
• Strong knowledge of U.S. and global healthcare laws and regulations, including the AKS/FCA (and related regulations, guidances, and safe harbors), FDACA, PhRMA Code, FCPA, relevant FDA Guidance and OIG Guidance and Advisory Opinions, FTC/FCC/SEC guidance (as applicable), etc.; additional experience with relevant ex-US laws and regulations is preferred.
• Excellent communication, analytical, and relationship-building skills with proven ability to work independently and cross-functionally.
• Desire to grow, develop, and learn outside of immediate subject matter expertise as opportunities arise.
• Ability to commute to the Brisbane office at least one day a week is preferred, although qualified remote candidates will be considered.

Notice to Recruiters/Staffing Agencies

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

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