Medical legal counsel

About Serova

Serova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. We work directly with patients, more like a consumer health company than a hospital, and we get them treatments through expanded access. That puts us in new legal territory.

The role

You'll help us understand and manage the legal side of two things: the expanded access pathway and our direct-to-consumer model.

What you'll do

• Own the legal framework for expanded access: single-patient and cohort INDs, state right-to-try laws, and Montana's experimental treatment law
• Advise on our direct-to-consumer model: telehealth, corporate practice of medicine, state licensing, and how we market to and talk with patients
• Keep how we charge, recover costs and work with referring physicians compliant with fraud and abuse rules
• Own patient consent, terms and privacy across the US and UK
• Handle contracts with partner sites, physicians, manufacturers and labs
• Flag legal risk early, with a recommended route

Who you are

• A healthcare regulatory lawyer who has advised a hospital or cancer center from the inside
• You give practical answers: how to do something, not only why we shouldn't
• Comfortable in untested areas of law
• High agency, friendly and low ego

Requirements

• A qualified US attorney
• 7+ years in healthcare or life sciences regulatory law, including time in-house
• Based in the San Francisco Bay Area or London, or willing to relocate
• Authorized to work in the US or UK, or a realistic path to get there

What will make you stand out

• In-house counsel at a hospital or cancer center: licensure, reimbursement and clinical research regulation
• FDA experience, at the agency or advising on it
• Expanded access, right-to-try or investigational treatment law
• Fraud and abuse: Anti-Kickback, Stark and the False Claims Act
• Direct-to-consumer healthcare: telehealth, corporate practice of medicine, patient advertising
• HIPAA and patient data

Details

• Location: San Francisco or London
• Type: Full-time or fractional

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