Senior Corporate Counsel, Global Legal R&D

Roche•South San Francisco, CA

68d•$203,800 - $378,400•Onsite

About The Position

As a member of the Roche Global Legal Pharma’s R&D Legal team, this Senior 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.

Requirements

7+ 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.
Advanced 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.
An understanding of business needs and the legal landscape such that your legal advice and guidance are routinely sought out and applied by the business.
An ability to support global working hours.

Nice To Haves

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.
Proactively track trends in the industry, identify resulting business needs and suggest solutions, and adapt direction of work accordingly.
Ability to approach complex problems with a creative and growth mindset.
Excellent verbal and written communication skills, awareness and ability to engage with others in a global ecosystem.
Excellent judgment and client-relations skills, and the desire to effectively collaborate with and influence multidisciplinary global clients and colleagues.
Deliver clear, concise, and practical advice and mitigation strategies to a range of legal and non-legal colleagues.
Proactively identify and provide solutions to address and manage risks.
Experience and comfort with AI for optimization of ways of working.
Prioritize and work with agility across multiple projects.
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.

Responsibilities

Proactively providing strategic business and legal advice and education related to FDA laws, regulations and guidance and other laws and regulations governing the research and development of biotech/pharmaceutical products.
Providing advice on early research through interventional trials, including drug, biologics, advanced therapy medicinal product, software as medical device, and biomarker and omics research.
Providing advice on the use of AI in research and development activities.
Providing advice on US and global data privacy.
Providing advice on Real World Data and non-Interventional studies.
Providing advice on Data Sharing.
Providing advice on Human subject protections.
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.