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Corporate Counsel, Global Legal R&D

Role overview

Qualifications

  • 5+ years of relevant legal experience in pharmaceutical, biotech, or related life science matters
  • U.S. law degree (J.D.) and current admission to at least one U.S. state bar
  • Proficient knowledge of Federal Food, Drug and Cosmetic Act and related regulations
  • Understanding of key aspects of the biotech/pharma industry

Responsibilities

  • Providing strategic business and legal advice related to FDA laws and regulations
  • Advising, drafting, and negotiating research collaborations and data sharing agreements
  • Developing and maintaining guidance and training on legal matters for internal clients
  • Collaborating with stakeholders and subject matter experts on legal support activities

Key facts

Other skills

  • Negotiation
  • Creative Problem Solving
  • Communication
  • Collaboration

About the company

Genentech logo

Genentech

Biotechnology

About Genentech We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers. Our patient resource center is dedicated to getting patients and caregivers to the right resources. You can reach them at 1 (877) GENENTECH (436-3683) Monday-Friday, 6am-5pm PST or patientinfo@gene.com. Community Guidelines: 1. We want to foster positive conversation and diverse community around the issues we are passionate about. To that end, we remove profanity, content that contains credible threats or hate speech, content that is aimed at private individuals, personal information meant to harass someone, and repeated unwanted messages. 2. Don’t mention any medicines by name — ours or anyone else’s. Because of the fair balance rules governing our industry, we cannot post any comments that reference any pharmaceutical brand, product, or service. Please do not mention any specific medicines by name, or include any links to third party sites in your comments. 3. This isn’t the place to report or discuss side effects. This site is not intended as a forum for reporting side effects experienced while taking a Genentech product. Instead, you should report any side effects to Genentech Drug Safety at 1-888-835-2555. You can also report side effects of any prescription product directly to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch. 4. Don’t pitch your product or service. Please don't use our page as a place to promote your product or pitch your services. Please also avoid posting links to external sites. We reserve the right to remove any posts that are deemed promotional.

Company details

Company typeXLarge
IndustryBiotechnology
Company size10001

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Job description

As a member of the Roche Global Legal Pharma’s R&D Legal team, this Corporate Counsel role will support global business functions within Roche’s Pharmaceutical division, such as Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs, by providing strategic legal advice to advance the company’s pipeline; this pipeline includes drug, device, digital and integrated solutions.   

The Opportunity

Key responsibilities of this role include the following:

  • Proactively providing strategic business and legal advice and education related to the following:

    • FDA laws, regulations and guidance and other laws and regulations governing the research and development of biotech/pharmaceutical products;

    • Early research through interventional trials, including drug, biologics, advanced therapy medicinal product, software as medical device, and biomarker and omics research, 

    • Use of AI in research and development activities

    • US and global data privacy

    • Real World Data and non-Interventional studies

    • Data Sharing

    • Human subject protection 

  • Advising, drafting, and negotiating complex research collaborations and data sharing agreements with academic institutions, healthcare institutions, government entities and other external partners; 

  • Developing, implementing, and maintaining guidance, playbooks, templates, processes and training on the same for internal clients and the Legal Department on issues related to the support of above activities.

  • Consulting and collaborating with internal and external stakeholders and subject matter experts to support the above activities, our internal global legal colleagues (IP, transactional, privacy, and product attorneys) as well as global business teams, regulatory experts, ethics experts, and legal policy committee members. 

PREFERRED SKILLS

Strategic and Trusted Advisor:

  • Demonstrated success in proactively translating legal analysis into actionable guidance by providing mitigation strategies and pragmatic solutions that take into account both the needs of the business and legal risks.

  • Ability to approach complex problems with a creative and growth mindset  

Influential Communicator and Influencer:

  • Excellent verbal and written communication skills, awareness and ability to engage with others in a global ecosystem

  • Good judgment and client-relations skills, and the desire to effectively collaborate with and influence multidisciplinary global clients and colleagues.

  • Ability to deliver clear, concise, and practical advice and mitigation strategies to a range of legal and non-legal colleagues.

Adaptive Performer and Systems-wide Collaborator:

  • Experience and comfort with AI for optimization of ways of working.

  • Ability to prioritize and work with agility across multiple projects.

  • Ability to work both in a global team and independently.

  • Aptitude and interest to learn the scientific/technical side of the business.

  • Comfortable with getting outside of one’s comfort zone, and stepping into new areas of practice or business.

Who You Are

  • 5+ years of relevant legal experience, which includes a focus on pharmaceutical, biotech, or related life science matters/clients.

  • A U.S. law degree (J.D.) and current “good standing” admission to at least one U.S. state bar, or be eligible to apply to California’s Registered In-House Counsel program.

  • Proficient knowledge of Federal Food, Drug and Cosmetic Act and related regulations; US fraud & abuse laws; and other applicable federal and state laws governing the research and development of human therapeutics. 

  • Understand key aspects of the biotech/pharma industry and see the broader implications of legal advice outside the immediate project. 

  • An ability to support global working hours.

This role is located onsite at Roche’s Genentech campus in South San Francisco, California.  A remote working arrangement is not available.  

Relocation benefits are not available for this job posting.

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.

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