Legal Counsel, Therapeutic Area Products

Genentech • Daly City, CA

8d • $181,800 - $337,600 • Onsite

About The Position

Genentech is hiring a Legal Counsel, Therapeutic Area Products, based at its campus in South San Francisco, California. The role is part of the Roche Global Legal Pharma group and serves as a key business partner and strategist, providing U.S. and global legal advice and support throughout the lifecycle of Roche/Genentech’s growing portfolio of innovative medicines. Supported functions include global product strategy, sales and marketing, commercial strategy and operations, regulatory, market access, U.S. medical affairs, government affairs, and certain global teams.

The position provides legal counseling on matters affecting the commercialization of biotech products, supports product lifecycle and cross-functional business teams, and advises on business strategies, transactions, regulatory matters, partnerships, and compliance. The role also develops and delivers training, works with co-promotion partners, and participates in company committees and advisory or project teams. The position is not eligible for a fully remote arrangement. Relocation benefits are not available.

The expected salary range for the California primary location is $181,800 to $337,600. Actual pay depends on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. The position qualifies for benefits described at a link in the posting.

Requirements

• Advanced law degree (JD).
• Currently licensed to practice law in good standing in at least one U.S. state.
• Registered or currently eligible as a Registered In-House Counsel in California.
• At least 5 years of legal counseling experience in-house or at a law firm.
• Significant knowledge of enforcement trends, the Federal Food, Drug, and Cosmetic Act and related regulations, the False Claims Act, and laws concerning fraud and abuse in the life sciences, biotech, or pharmaceutical industries.
• Excellent oral and written communication skills.
• Team-oriented and able to collaborate in global, matrixed environments.
• Ability to influence without authority and present complex information to senior leaders.
• Adaptability for possible early-morning or late-evening calls to accommodate global time zones.
• Willingness to undertake necessary international travel to provide effective global support and alignment.

Nice To Haves

• Experience counseling on therapeutic-area product support for biotech or pharmaceutical clients.

Responsibilities

• Provide advice, education, training, and legal direction on healthcare fraud and abuse laws, pricing, access, FDA labeling and promotion, cGMP compliance, product liability, antitrust, privacy, and other laws affecting biotech product commercialization.
• Serve as lead legal counsel, as appropriate, for product lifecycle and cross-functional product- or therapeutic-area-focused business teams and initiatives.
• Advise on business strategies, tactical plan development and implementation, and other business issues, including legal assessments and solutions-oriented risk mitigation strategies.
• Advise on transactions supporting external collaborations and partnerships.
• Advise regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations, privacy, and data use.
• Counsel on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities.
• Develop and implement training for internal clients, partners, and stakeholders on healthcare and related legal compliance policies, procedures, practices, requirements, and current enforcement trends.
• Liaise and negotiate with co-promotion partners’ legal counsel to support successful partnership outcomes.
• Identify opportunities to create value for the business and Legal colleagues; manage legal issues; foster strong client and Legal colleague relationships; create efficient and effective client processes; advise senior business leaders; and serve as a standing or ad hoc member of business or leadership teams.
• Participate in, lead, or present to company committees and other advisory, project, or work teams.

Benefits

• Benefits are available as detailed at the link referenced in the posting.
• A discretionary annual bonus may be available based on individual and company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior