Senior Counsel II – Development Legal Business Partner (PDM)

Gilead Sciences is seeking development and regulatory counsel to serve as a primary legal partner to global Development functions. The role provides legal guidance across regulatory and development matters throughout the product lifecycle, collaborates with cross-functional and international teams, and helps develop practical solutions to complex business issues.

Responsibilities:

• Serving 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 (GATs)
• Providing legal guidance for the portfolio of Gilead products on GXP requirements, adverse-event reporting, data integrity, clinical data management, inspection and audit readiness, quality investigations, product quality and CMC matters, and regulatory submissions and health-authority interactions; Advising the business on a variety of supply chain issues, including drug shortages, product recalls and regional export and import requirements
• Keeping up to date and maintain knowledge advising on pertinent regulatory developments relevant to the business in the U.S. and key international markets
• Assisting in the drafting and review of agreements related to various business needs, including Quality Agreements
• Advising 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
• Providing regulatory and development counsel to the Corporate Legal team for mergers and acquisitions, licenses, collaborations, and other strategic transactions
• Providing legal interpretation of complex and evolving regulatory requirements and translating them into risk-based compliance programs, governance structures, policies, controls, and operational processes that enable compliant execution of business objectives
• Proactively identifying the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents
• Supporting and collaborating with  a global matrix of teams effectively, including partnering with other members in Legal, Ethics and Compliance, Government Affairs, Public Affairs, in Foster City and international affiliates, including the Intercontinental Region (ICR) and Global Patient Solutions (GPS),to ensure consistency in guidance and approach across areas of the overall business and help the business operate within legal, regulatory, and ethical requirements
• Establishing strong partnership relationships with global Research and Development teams, as well as key cross functional teams engaged in development activities, characterized by a high-level of collaboration, responsiveness, strong understanding of scientific and business objectives, and mutual respect
• Driving increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders
• Defining, direct, and conscientiously manage the work of outside counsel; and
• Providing senior business stakeholders with training and updates, policy support, and learnings to support effective risk management
• Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
• Develop Talent – understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose
• Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

Requirements:

• The successful candidate will be able to work independently and possess a strong knowledge of U.S. pharmaceutical regulatory laws, rules and regulations, industry practices and standards, and have demonstrated experience in analyzing complex issues and developing innovative solutions to business challenges
• The candidate will possess a strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance considerations and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives
• 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, or a combination of both
• preferably at a multinational company and/or a reputable, highly rated law firm
• 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 and clearly communicate requirements and rationale for advice
• Ability to manage workload priorities in a matrixed environment
• Experience handling multiple projects in fast-paced environment, with a high degree of client service orientation, and performing successfully in cross-functional teams
• Able to independently handle complex matters with minimal supervision and an understanding of when to elevate issues to senior management for awareness or decision-making
• Proven judgment in working through complex issues, including those with significant strategic risk considerations
• Demonstration of excellent interpersonal, strategic thinking, communication, and organizational skills
• Consistent demonstration of Gilead's core values: Teamwork, Accountability, Inclusion, Excellence and Integrity