Senior Counsel II – Development Legal Business Partner

Job not on LinkedIn

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $221k - $286k / year

⏰ Full Time

🟠 Senior

⚖️ Legal Counsel / General Counsel

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Serve as a Legal Business Partner to global Development functions, including Clinical Development, Clinical Operations, Regulatory Affairs, Regulatory Policy and Intelligence, R&D Quality, Patient Safety, and cross-functional Gilead Asset Teams • Provide legal guidance on GXP requirements, adverse-event reporting, data integrity, clinical data management, inspection and audit readiness, quality investigations, product quality and CMC matters, regulatory submissions, and health-authority interactions • Advise on supply chain issues, including drug shortages, product recalls, and regional export and import requirements • Maintain knowledge of pertinent regulatory developments in the U.S. and key international markets • Draft and review agreements, including Quality Agreements • Advise across the product lifecycle, including development strategy, regulatory pathways, established-product considerations, loss of exclusivity, strategic discontinuation or withdrawal of marketing authorizations, and regulatory data protection • Provide regulatory and development counsel for mergers and acquisitions, licenses, collaborations, and other strategic transactions • Translate complex regulatory requirements into risk-based compliance programs, governance structures, policies, controls, and operational processes • Draft and advise on corporate policies, SOPs, and guidance documents • Collaborate with Legal, Ethics and Compliance, Government Affairs, Public Affairs, Foster City teams, and international affiliates • Establish partnerships with global Research and Development teams and cross-functional development teams • Drive efficiency, coordination, and effectiveness of legal advice, processes, and business support • Define, direct, and manage outside counsel • Provide senior business stakeholders with training, policy support, and updates for effective risk management

🎯 Requirements

• U.S. Juris Doctorate (J.D.) degree • Active law license in at least one U.S. jurisdiction • 6+ years of legal experience supporting clients in the pharmaceutical industry • Strong knowledge of U.S. pharmaceutical regulatory laws, rules and regulations, industry practices and standards • Experience advising clients on FDA and regulatory matters, preferably with some device expertise • Ability to exercise judgment and independently determine and take appropriate action • Ability to translate complex legal requirements into practical recommendations and solutions • Ability to manage workload priorities in a matrixed environment • Experience handling multiple projects in a fast-paced environment • Ability to independently handle complex matters with minimal supervision • Proven judgment in working through complex issues with significant strategic risk considerations • Excellent interpersonal, strategic thinking, communication, and organizational skills • Consistent demonstration of Gilead’s core values: Teamwork, Accountability, Inclusion, Excellence and Integrity

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance

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