Gilead Sciences, Inc.
Head of CMC Regulatory Affairs – Strategy and Operations
Gilead Sciences, Inc., Foster City, California, United States, 94420
* Oversee digital modernization of core CMC RA platforms (e.g., RIM) and integration across systems.* Stand up for CMC RA (with enterprise thinking) and oversee a digital/AI fluency and enablement team aligned to strategic priorities.* Create guidelines, systems, and processes for CMC RA knowledge management, in alignment and partnership with any broader initiatives in this space across the enterprise.* Lead workforce capability design, training strategy, and upskilling initiatives.
**Domain Knowledge & Experience*** Requires a PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience – a degree in chemistry or a related scientific discipline is strongly preferred.* Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives.* Experience with CMC requirements for drug development of a range of product modalities.* Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework.* Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset.* Understanding of structured content, automation, and enterprise knowledge systems.* Strategic thinking and ability to influence and constructively challenge the status quo.* Strong business acumen.* Ability to blend strategic acumen, regulatory fluency, and operational rigor with a strong background in change leadership, data governance, and digital transformation.* Experience in managing organizational cross-functional initiatives and/or business operations programs.* Ability to design and optimize organizations.* Excellent organizational and communication (both written and verbal) skills with all levels of an organization.* Ability to work and influence within a matrixed environment and regularly collaborate with cross-functional teams across Technical, Research, and Development.* Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations. #J-18808-Ljbffr
**Domain Knowledge & Experience*** Requires a PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience – a degree in chemistry or a related scientific discipline is strongly preferred.* Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives.* Experience with CMC requirements for drug development of a range of product modalities.* Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework.* Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset.* Understanding of structured content, automation, and enterprise knowledge systems.* Strategic thinking and ability to influence and constructively challenge the status quo.* Strong business acumen.* Ability to blend strategic acumen, regulatory fluency, and operational rigor with a strong background in change leadership, data governance, and digital transformation.* Experience in managing organizational cross-functional initiatives and/or business operations programs.* Ability to design and optimize organizations.* Excellent organizational and communication (both written and verbal) skills with all levels of an organization.* Ability to work and influence within a matrixed environment and regularly collaborate with cross-functional teams across Technical, Research, and Development.* Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations. #J-18808-Ljbffr