Job ID: 202112-135868
Position Scope and Key Responsibilities:
Senior Counsel/Senior Counsel Specialist, Assistant General Counsel, Research & Development, Corporate Law
The Senior Counsel/Senior Counsel Specialist, Assistant General Counsel, Research & Development, Corporate Law will work as part of the Global Functional Practice Group in the Corporate Law Group within Genentech's Legal Department. The Global Functional Practice Group supports activities conducted by teams operating globally with respect to issues related to product development, Personalized Healthcare, Data privacy, Pharmacovigilance, Trade Compliance, and Manufacturing and Quality Compliance. 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
- Data Sharing
- 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.
- 7-15 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.
The Corporate 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.