- Providing legal advice, education, and actively resolving legal issues related to the following:
- Conducting early research through clinical trials (GxP compliance, diversity in clinical trials, subject recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent and research privacy, etc.);
- Biomarker, genomic research and emerging data and digital solutions pertinent to R&D;
- Real World Data and secondary use of research data; and
- Pre-approval and expanded access to investigational medicinal products.
- Serving as lead legal counsel for global development programs involving innovative scientific initiatives with external collaborators including pharmaceutical manufacturers, digital or device developers, academic institutions, research collaborative groups, and government entities;
- 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); and
- Consulting and collaborating with internal and external stakeholders and subject matter experts to support the above activities, including IP, transactional, privacy and product attorneys, as well as business leadership, regulatory experts, ethics experts and legal policy committee members.
- JD required, must be licensed and currently in good standing to practice law in one or more jurisdictions.
- Must have at least 7 years of recent relevant legal experience.
- Must be able to work global working hours.
- Must have significant knowledge of the human subject protection laws, 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 therapeutics.
- Must have significant transactional experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.
- Demonstrated success in proactively and independently driving for and delivering results with high impact on matters related to pharmaceutical research and development.
- Ability to approach complex problems with a creative and growth mindset.
- Experience with medical device R&D and digital health is helpful though not required, but a willingness to learn is a must.
- Excellent verbal and written communication skills, awareness and ability to engage with others of diverse backgrounds.
- Excellent judgment and superior client-relations skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary, diverse and global clients and colleagues.
- Ability to deliver clear, concise and practical advice regarding challenging legal issues to legal and non-legal colleagues, including senior management.
- Ability to prioritize and work with agility across multiple projects.
- Ability to work both in a 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.
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Senior Counsel, Research - South San Francisco, United States - Roche
Description
The PositionThe Genentech R&D Law Group is seeking a highly experienced R&D attorney. As a partner and key business strategist, this individual will have deep experience in regulatory law and complex transactional legal support for global strategies and activities related to product research and development, digital health and personalized healthcare.
As a member of the R&D Law Group, this individual will primarily support Genentech's Research and Early Development (gRED), Global Product Development and Medical Affairs functions by providing strategic legal advice to advance the company's pipeline; including: drug, device, digital and integrated solutions.
This position will be based onsite in South San Francisco, California or Little Falls, New Jersey. Relocation benefits are not available for this posting.
Key Responsibilities:
Key responsibilities will include but not limited to:
For this position, we are seeking an attorney with the following qualifications:
Critical Competencies:
Strategic R&D Expert:
Influential Communicator and Influencer:
Adaptive Performer and Systems-wide Collaborator:
The R&D Law Group, as part of the Genentech Corporate 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.
The expected salary range for this position based on the primary location of California is $198,500 to $368,600. 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
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
