Legal Counsel, Therapeutic Area Products

Genentech; South San Francisco (CA); On-site; USD 182,000 - 338,000; Full time

Job summary

Genentech, Inc. is seeking a Legal Counsel for Therapeutic Area Products based on the Genentech campus in South San Francisco, CA. The role provides US and global legal guidance across the lifecycle of biotech medicines, supporting commercial, medical affairs, market access and regulatory teams.

The candidate will advise on FDA labeling, pricing, PMDA/EMA considerations, data privacy, and cross-functional matters. Strong communication, collaboration, and a willingness to travel are essential.

Qualifications

• J.D. degree and active U.S. bar admission; in-house counsel eligibility in California.
• 5+ years of legal counseling experience in-house or at a law firm, preferably biotech/pharma.
• Significant knowledge of enforcement trends, FDA regs, False Claims Act and life sciences laws.
• Excellent written and oral communication; ability to influence senior leaders.
• Willingness to travel internationally as needed.

Responsibilities

• Provide legal advice on healthcare, pricing, labeling, promotions, and compliance matters.
• Lead or serve as lead counsel for product lifecycle teams and cross-functional initiatives.
• Advise on business strategies, risk mitigation, and strategic deals.
• Support regulatory submissions, label negotiations and privacy/data use.
• Interact with healthcare professionals, providers, customers, and government entities.
• Develop training for clients and stakeholders on key policies and enforcement trends.
• Negotiate with partners' counsel to enable collaborations and partnerships.
• Collaborate with global teams and leadership on complex matters.

Skills

Oral and written communication

Global matrixed collaboration

Influence without authority

Cross-functional teamwork

Willingness to travel internationally

Education

J.D. with bar admission in at least one US state

Job description

The Position

Genentech is hiring a Legal Counsel, Therapeutic Area Products, based on the Genentech campus, a member of the Roche Global Legal Pharma group. As a key partner and business strategist, this position will provide US and global legal advice and support across the lifecycle of Roche/Genentech’s growing portfolio of innovative medicines, including commercial, medical affairs, market access, and government affairs. Supported business teams include global product strategy teams, product sales and marketing, commercial strategic and operational functions, regulatory, market access (patient access, pricing, contracting and distribution), U.S. medical affairs, and certain global teams.

THE OPPORTUNITY

Key responsibilities of this individual contributor role includes the following:

• Providing advice, education, training and legal direction on, healthcare fraud and abuse laws, pricing, access, FDA labeling and promotional matters, cGMP compliance, products liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
• May serve as lead legal counsel for product lifecycle and cross-functional product or therapeutic area-focused business teams and initiatives;
• Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies;
• Advising on transactions to support external collaborations and partnerships;
• Advising regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use;
• Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities;
• Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance, and on current enforcement trends;
• Liaising and negotiating with co-promotion partners’ legal counsel to enable and drive for successful partnership outcomes;
• Identifying opportunities to create value to the business and Legal colleagues and manage legal issues, fostering strong relationships with client groups and Legal colleagues, creating efficient and effective processes for working with clients, advising senior business leaders, and acting as a standing or ad hoc member of business or leadership teams; and
• Participating in, leading and/or presenting to various Company committees or other advisory, project or work teams.

WHO YOU ARE

Required Education, Experience and Competencies:

• Education & Legal Bar License: Must have an advanced law degree (i.e. JD) and must be currently licensed to practice law, in good standing, in at least one U.S. state, and must be registered or currently eligible as a Registered In-House Counsel in California.
• Experience: 5+ years of work experience in legal counseling in-house or at a law firm. Preferred experience in legal counseling of therapeutic area product support for biotech/pharma clients.
• Subject Matter Expertise: Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the life science/biotech/pharma industries.
• General Competencies: Excellent and effective oral and written communications skills. Team player and strong collaboration skills for global, matrixed environments. Ability to influence without authority and present complex information to senior leaders.
• Global Operating Model and Travel: Requires adaptability for possible early morning/late evening calls to accommodate global time zones and a willingness to undertake necessary international travel to ensure effective global support and alignment.

Location

• This role is located at Roche’s Genentech campus in South San Francisco, California.
• Relocation benefits are not available for this position.
• This role is not allowable for a fully remote working arrangement.

The expected salary range for this position based on the primary location of California is$181,800 to $337,600. Actual pay will be determined based 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. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.