Description:
The Position: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.
