Job Details

Overview

Vice President, Analytical Development – United States - California - Foster City

The Vice President, Analytical Development will provide strategic and technical direction across the entire product lifecycle, from early development to commercialization for all modalities. This leader will identify synergies across modalities to efficiently support Gilead's full development portfolio and develop a strategic vision to seamlessly bring small molecules and large molecules together. The role will ensure state-of-the-art technology is leveraged to support the diverse portfolio and report to the SVP of Technical Development as a member of the Technical Development Leadership Team.

Responsibilities

• Provide leadership and direction to the Analytical Development organization, a department of 200+ scientists
• Set strategies and develop long-range plans for all modalities in line with Gilead strategic priorities
• Provide technical guidance and drive alignment of near-term deliverables and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across all PDM functions
• Oversee analytical method development and analytical characterization for all drug substances and drug products in R&D programs
• Oversee data generation / data integrity
• Lead analytical team leads for Gilead Development Team and Commercial PDM sub-teams
• Direct AD leads for all PDM project teams and all commercial project teams
• Serve as a key advisor for the review of relevant PDM project reviews
• Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing PDM development strategies
• Evaluate and implement new technologies to drive innovation in Analytical Development and testing
• Drive development and implementation of new systems to improve project execution and data management
• Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs, Manufacturing and Technical Operations, Product and Portfolio Management, Finance, and Supply Chain
• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, Clinical Supply Management, and Program Strategy Teams by providing technical and strategic input
• Hire, mentor, and develop team members within the organization
• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
• Provide technical support to internal and external cGMP manufacturing operations
• Develop and manage department budget

Qualifications

• Typically requires a PhD, MS, or BS in chemistry or related fields with 20+ years of relevant experience
• Must have CMC experience with a range of modalities, including small molecules, peptides, ADCs, and biologics – with 15+ years of relevant experience in biologics preferred
• Recognized as leader in the field of Analytical Development with extensive external experience with relevant multi-national scientific organizations, conferences, associations, and health authorities
• Sound knowledge of chemistry, analytical technologies, computerized systems, and data integrity
• Well-versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance, drug product, and devices
• Well-versed in analytical control strategies
• Experience with analytical testing networks
• Strong business acumen, including business contracting expertise
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection
• Proven ability to lead high performing teams
• Leadership qualities include collaboration, building and developing high performing teams, accountability, cross-functional engagement and influence, program management, and strategic vision

People Leader Accountabilities

• Create Inclusion - know the value of diverse teams and model inclusion in how they manage their teams
• Develop Talent - understand skills, experience, aspirations and potential; coach on current performance and future potential
• Empower Teams - align goals and purpose with organizational objectives, remove barriers, and connect teams to the broader ecosystem

Gilead Core Values

• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

Job Requisition ID R0045290

Job Level: Vice President