The Position
The Genentech R&D Law Group is seeking a highly experienced R&D attorney for life sciences/biotech clients, with deep experience in regulatory law related to early and late stage research and development of pharmaceutical products, digital health, and medical devices. As a member of the R&D Law Group, this "Senior Counsel Specialist, Assistant General Counsel" role will primarily support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions 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, education, and actively resolving legal issues related to the following:
Conducting research through clinical trials (GxP compliance, study participant recruitment and retention, decentralized trials, patient safety, pharmacovigilance, informed consent, research privacy, clinical contracting, 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 and/or medical devices.
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 enterprise-wide legal issues, based on an excellent understanding of business strategy and goals, fostering trusted relationships with client groups, advising leaders in the R&D and Medical Affairs organizations, 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, our internal legal colleagues (IP, transactional, privacy, and product attorneys) as well as VP-level business leadership, regulatory experts, ethics experts, and legal policy committee members.
CRITICAL COMPETENCIES
Strategic R&D Expert:
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, able to navigate risks by providing mitigation strategies and pragmatic solutions.
Experience with AI, advanced therapy medical products (ATMP), medical device R&D, and digital health is helpful though not required, but a willingness to learn is a must.
Influential Communicator and Influencer:
Excellent verbal and written communication skills, awareness and ability to engage with others in a global ecosystem, along with a confidence for advising VP-level leadership and swiftly responding to and de-escalating as needed
Excellent judgment and superior client-relations skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary global clients and colleagues.
Ability to deliver clear, concise and practical advice and mitigation strategies regarding challenging legal issues to legal and non-legal colleagues, including senior management.
Adaptive Performer and Systems-wide Collaborator:
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.
Who You Are
10+ years of relevant legal experience, which includes a focus on pharmaceutical, biotech, or related life science matters/clients, 5+ years of which should be in-house with a biotech/pharma company.
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.
An ability to support global working hours.
Must have demonstrable mastery of human subject research protection laws; Federal Food, Drug and Cosmetic Act and related regulations; US and global privacy laws; US fraud & abuse laws; and other applicable federal and state laws governing the research and development of human therapeutics.
Must have significant experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.
This role is located onsite at Genentech's South San Francisco, California campus, and a remote working arrangement is not available.
Relocation benefits are available for this job posting.
The expected salary range for this position based on the primary location of California is $209,700 to $389,500. 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 (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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 (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .
