
51 - 200 employees
💼 Consulting
🏭 Manufacturing
🧬 Biotechnology
Consulting • Manufacturing • Biotechnology
4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.
🕒 August 24
🇺🇸 United States – Remote
💵 $242k - $282k / year
⏰ Full Time
🔴 Lead
⚖️ Legal Counsel / General Counsel
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51 - 200 employees
💼 Consulting
🏭 Manufacturing
🧬 Biotechnology
Consulting • Manufacturing • Biotechnology
4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.
• Lead drafting, review, negotiation, and execution of clinical trial, clinical site and investigator, CRO/vendor services, master services, work order, change order, CDMO development, supply, manufacturing services, quality, material transfer, and technology transfer agreements • Review and advise on informed consent forms, letters of authorization, letters of indemnification, and other clinical trial documents • Provide strategic and legal counsel to clinical trial teams and internal stakeholders • Advise on contractual risk allocation, indemnification, liability limitations, intellectual property ownership, data rights, confidentiality, and regulatory compliance • Review, approve, and advise on external-facing materials and outreach initiatives • Assist with Legal Department policies, procedures, templates, and playbooks • Support continuous improvement of the contracts lifecycle management system • Manage outside counsel based on cost, review speed, and technical expertise • Report directly to the Executive Director, Corporate Counsel • Perform other duties as assigned • Travel: 5%
• JD degree or equivalent from an accredited law school required • Admission to, and in good standing with, at least one U.S. state bar (CA preferred but not required) • 8+ years practice as an attorney • 5+ years of in-house experience in the life sciences industry • Experience counseling life sciences clinical and manufacturing teams on day-to-day transactions and risk mitigation strategies • Proven experience reviewing and negotiating a wide range of contracts under tight timelines with autonomous decision making • Proficient knowledge of FDA regulations, ICH Guidelines, GxPs, FDCA, FCPA, FCA, AKS, HIPAA, and data privacy laws • Experience handling commercial contract disputes and dispute resolution • Experience working with Finance teams and auditors, managing contract processes and policies, and using contracts lifecycle management tools • Service-oriented focus and ability to work as part of cross-functional teams and drive results • Highest integrity, excellent judgment, proactive recognition and communication of legal issues • Ability to manage a full docket in a dynamic, fast-paced environment with aggressive timelines • BSc in molecular biology, genetics, biochemistry, or another related biological field is beneficial but not required • Experience at a publicly traded biotechnology, pharmaceutical, or biopharmaceutical company, large law firm life sciences experience, and global clinical trial/IP/technology transaction experience are strongly preferred or beneficial
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