Senior Counsel Specialist, Assistant General Counsel- R&D Law Group jobs in United States
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Genentech · 3 hours ago

Senior Counsel Specialist, Assistant General Counsel- R&D Law Group

Genentech is seeking a highly experienced R&D attorney for life sciences/biotech clients. This 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 of drug, device, digital and integrated solutions.

BiotechnologyLife ScienceManufacturing
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

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)
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

Qualification

Regulatory law expertiseClinical development experienceHuman subject research lawsPharmaceutical research knowledgeDigital health familiarityCommunication skillsClient relations skillsAgility in project managementTeam collaborationCreative problem-solving

Required

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

Preferred

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

Benefits

Relocation benefits are available for this job posting.
A discretionary annual bonus may be available based on individual and Company performance.

Company

Genentech

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Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.

H1B Sponsorship

Genentech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)

Funding

Current Stage
Public Company
Total Funding
unknown
2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown

Leadership Team

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Ashley Magargee
CEO
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Michael Laird
Vice President
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Company data provided by crunchbase