The Sr. Counsel Specialist, Assistant General Counsel will work as part of the Healthcare Law Group within Genentech's Legal Department. The position will have the opportunity to provide legal advice and support to Genentech’s Global and US Research and Development and Medical Affairs Functions including those responsible for Data Sharing, Real World Data, Personalized Healthcare and Digital Health technologies.
Specific activities may include the following:
Providing advice, education, training and legal direction on the following:
US and global data privacy
Real World Data
Human subject protection
Early research through interventional trials, including drug, device and non-interventional studies, and biomarker and genomic research,
Health equity and inclusive research
FDA laws, regulations and guidance and other laws and regulations governing the research and development of biotech products and digital health technologies
Advising, drafting and negotiating complex research collaborations and data sharing agreements with academic institutions, healthcare institutions, government entities and other external partners;
Consulting and collaborating with internal and external stakeholders and subject matter experts to support the above activities, including business leadership, patent counsel, transaction counsel, privacy counsel, regulatory experts, ethics experts and legal policy committee members; and
Developing and implementing playbooks, templates, processes and training on the same for internal clients and the Legal Department on issues related to the support of above activities, including complex transactions.
The Healthcare Law Group, as part of the Genentech Law Department, values ongoing professional development and collegiality in support of our vision to be essential partners to our clients, driving business excellence to improve patient lives. We seek and cultivate self- motivated individuals who share this vision and consistently demonstrate excellent judgment and ethics while delivering solutions-oriented, proactive, and strategic legal advice.
At least 10 years of recent relevant legal experience.
Licensed to practice law in one or more jurisdictions.
Significant knowledge of the Federal Food, Drug and Cosmetic Act and related regulations, US and Global privacy laws, and other applicable federal and state laws governing the research and development of human medicines.
Significant transactional experience involving clinical development programs, data sharing arrangements, complex research collaborations and consortia.
Excellent oral and written communications skills.
Demonstrated leadership and organizational savvy necessary to lead and collaborate effectively with cross-functional client teams located in the US and globally.
Team player and strong collaboration skills.
Proactively identifying and addressing legal issues, fostering trusted relationships with client groups, advising leaders in the research and development and medical affairs organizations and serving as a standing or ad hoc member of business or leadership team(s).
Strong ability to influence and present complex information to senior leaders and tackle challenging issues beyond the practice area.
Demonstrated success in proactively and independently driving for and delivering results with high impact.
Enterprise and growth mindset.
Internal Number: 202105-111988
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, se...xual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.