Senior Counsel II – Development Legal Business Partner (PDM)

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Gilead is seeking a development and regulatory counsel to join its Global Development & PDM Legal Business Partner team.  The candidate will serve as a primary point of contact for the business, be responsible for advising and collaborating on a range of regulatory and development matters throughout the product lifecycle, liaise with other legal experts, and develop solutions for complex business matters. 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. The candidate will work closely with Regulatory Affairs, Regulatory CMC, Quality, Global Patient Safety, Program Strategy Teams (PSTs), Development Teams, Clinical, and global affiliates.  The candidate will work across Gilead’s Corporate and Legal organization to coordinate and communicate legal input on matters in collaboration with other Gilead Legal Business Partners, the Office of Ethics and Compliance, Government Affairs, and Public Affairs, across geographic and therapeutic areas. While this position is posted as remote, candidates who are based Foster City, CA and able to work onsite are strongly preferred. Core Job Responsibilities Include 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. U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction; Basic Qualifications: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, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both; Preferred Qualifications: 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; and Consistent demonstration of Gilead’s core values: Teamwork, Accountability, Inclusion, Excellence and Integrity. Critical Success Factors Judgment: Demonstrates expertise and sound judgment, understands how assigned responsibilities support Gilead’s business objectives, and is able to provide practical, risk-balanced advice based upon a thoro