Job Description

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are — it is in our chromosom es — and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs), and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job (brief description)

The Vice President, Compliance Officer role will report to the General Counsel and oversee Soleno’s compliance and privacy functions. This position requires an onsite presence in Redwood City, CA, several days per week.

Responsibilities

• Serve as a key subject matter expert in supporting the compliance needs of the Commercial, Clinical, Medical Affairs, and Regulatory functions of the organization.
• Primary responsibility for implementation and maintenance of policies with respect to healthcare corporate compliance, sales and marketing compliance, privacy compliance, and data governance.
• Assist with marketing strategies, manage contracting arrangements with HCPs, evaluate promotional and non-promotional practices, and manage the process and capture of data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act and state law reporting.
• Provide guidance across the commercial and medical affairs organizations on interactions with patients and HCPs, including on topics such as fair market value, advisory board participation, and speaker programs.
• Provide guidance on U.S. advertising and promotion laws, as well as acting as brand counsel, supporting sales, marketing, and medical affairs functions.
• Monitor regulatory, legislative, and enforcement landscape to guide internal practices and policies.
• Develop and track internal training and monitor compliance with applicable policies.
• Serve on the promotional review committee, medical review committee, compliance committee, and other committees as may be assigned.
• Implement and maintain an effective compliance reporting program including use of a compliance hotline and other internal reporting systems.
• Implement privacy controls and data strategy, including compliance with GDPR and HIPAA, including permissible data uses and regulatory guidance to current business processes, new product development, research collaborations, and commercial partnerships.

Qualifications

• A U.S.-based law degree from an accredited law school.
• Active member of state bar, preference for California.
• 10+ years of compliance and privacy experience in in-house biotech, pharmaceutical, other life sciences, or healthcare companies, relevant law firm experience, and/or government experience.
• Comprehensive knowledge of the laws, regulations, industry standards, and guidelines for interactions with HCPs and other ethical codes and regulations. Experience with product launches a plus.
• Excellent communication skills, both oral and written, and the ability to convey complex legal issues clearly.
• Well-organized and hardworking, with the ability to manage numerous projects simultaneously as well as be an individual contributor.
• Self-directed with a desire to be part of a small team within a high-growth, transformational company. Role will not initially have any direct reports.

Salary Range: $295,000 - $335,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)

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