Senior Counsel II – Development Legal Business Partner
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Job Description
Development and regulatory counsel advising Gilead’s pharmaceutical business on FDA, clinical, quality, and product lifecycle matters. Partnering with global development, regulatory, and legal teams.
Responsibilities:
- 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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