California Jobs
Senior Director; Head of CMC Regulatory Affairs Digital Enablement.
California Jobs, San Francisco, California, United States, 94199
Overview
Senior Director; Head of CMC Regulatory Affairs Digital Enablement – Gilead Sciences Join to apply for the Senior Director; Head of CMC Regulatory Affairs Digital Enablement role at Gilead Sciences. 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, and we continue to fight major health challenges with a mission to develop therapies that improve lives and ensure access globally. We're seeking a passionate and ambitious leader to drive digital enablement within CMC Regulatory Affairs (RA) and enable faster, more efficient regulatory submissions and decision-making. Responsibilities
Strategy and Roadmap Development: Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise platforms. Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. Translate CMC-specific digital needs into business cases for enterprise-level investments. Lead business case development and ROI analyses for new digital investments, communicating trade-offs between speed, cost, and scope to leadership. Program Delivery and Vendor Coordination: Partner with IT to identify, evaluate, and create strategic partnerships with technology providers. Drive digital pilots and implementations (e.g., SCMS, NLP-based HAQ clustering, automated impact assessments). Foster relationships with internal partners and external vendors. Define and track KPIs and OKRs for digital initiatives, linking them to business outcomes such as submission cycle time reduction, improved inspection-readiness, and enhanced data reuse. Innovation, Change Leadership, and Continuous Improvement: Articulate a compelling vision for digital transformation within CMC RA. Scan the digital landscape for emerging tools. Lead change management, including upskilling, communication planning, and user adoption. Partner with Continuous Improvement to identify areas where digital can remove friction or enable leapfrog innovation. Collaboration and Influence: Serve as a bridge between CMC RA and PDM digital governance groups. Represent CMC RA in enterprise-wide digital steering committees and content working groups. Align efforts with data governance, structured data initiatives, and broader RA digital programs. Qualifications
Education & Experience: Bachelor's degree in a scientific or technical discipline required (advanced degree preferred) with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ years with an advanced degree. Five or more years of experience in digital or innovation roles preferred. Strong understanding of CMC regulatory submissions and the structure/content of Module 3. Preferred: Certifications in product ownership (e.g., CSPO), business relationship management (e.g., CBRM), or agile methodologies (e.g., SAFe). Technical & Strategic Skills: Demonstrated enterprise mindset to align CMC RA needs to enterprise platforms; product management mindset; experience with Veeva Vault RIM, SCMS, cloud-based submission solutions or equivalent; expertise in AI/ML/NLP use cases in life sciences; data governance and data engineering knowledge; ability to standardize data per regulatory authorities (e.g., ALCOA, DSAB). Leadership & Soft Skills: Strong strategic thinking and business case development; excellent communication and stakeholder engagement; change agent with ability to inspire adoption and build digital fluency across teams. Compensation and Benefits
The salary range for this position is $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. For additional benefits information, visit: gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Recruitment and selection decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other non-job related characteristics or other prohibited grounds by applicable laws. Reasonable accommodation is available for applicants protected by Section 503 of the Rehabilitation Act, the Vietnam Era Veterans\' Readjustment Act, and the Americans with Disabilities Act. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Current Gilead employees and contractors: please apply via the Internal Career Opportunities portal in Workday.
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Senior Director; Head of CMC Regulatory Affairs Digital Enablement – Gilead Sciences Join to apply for the Senior Director; Head of CMC Regulatory Affairs Digital Enablement role at Gilead Sciences. 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, and we continue to fight major health challenges with a mission to develop therapies that improve lives and ensure access globally. We're seeking a passionate and ambitious leader to drive digital enablement within CMC Regulatory Affairs (RA) and enable faster, more efficient regulatory submissions and decision-making. Responsibilities
Strategy and Roadmap Development: Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise platforms. Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. Translate CMC-specific digital needs into business cases for enterprise-level investments. Lead business case development and ROI analyses for new digital investments, communicating trade-offs between speed, cost, and scope to leadership. Program Delivery and Vendor Coordination: Partner with IT to identify, evaluate, and create strategic partnerships with technology providers. Drive digital pilots and implementations (e.g., SCMS, NLP-based HAQ clustering, automated impact assessments). Foster relationships with internal partners and external vendors. Define and track KPIs and OKRs for digital initiatives, linking them to business outcomes such as submission cycle time reduction, improved inspection-readiness, and enhanced data reuse. Innovation, Change Leadership, and Continuous Improvement: Articulate a compelling vision for digital transformation within CMC RA. Scan the digital landscape for emerging tools. Lead change management, including upskilling, communication planning, and user adoption. Partner with Continuous Improvement to identify areas where digital can remove friction or enable leapfrog innovation. Collaboration and Influence: Serve as a bridge between CMC RA and PDM digital governance groups. Represent CMC RA in enterprise-wide digital steering committees and content working groups. Align efforts with data governance, structured data initiatives, and broader RA digital programs. Qualifications
Education & Experience: Bachelor's degree in a scientific or technical discipline required (advanced degree preferred) with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ years with an advanced degree. Five or more years of experience in digital or innovation roles preferred. Strong understanding of CMC regulatory submissions and the structure/content of Module 3. Preferred: Certifications in product ownership (e.g., CSPO), business relationship management (e.g., CBRM), or agile methodologies (e.g., SAFe). Technical & Strategic Skills: Demonstrated enterprise mindset to align CMC RA needs to enterprise platforms; product management mindset; experience with Veeva Vault RIM, SCMS, cloud-based submission solutions or equivalent; expertise in AI/ML/NLP use cases in life sciences; data governance and data engineering knowledge; ability to standardize data per regulatory authorities (e.g., ALCOA, DSAB). Leadership & Soft Skills: Strong strategic thinking and business case development; excellent communication and stakeholder engagement; change agent with ability to inspire adoption and build digital fluency across teams. Compensation and Benefits
The salary range for this position is $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. For additional benefits information, visit: gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Recruitment and selection decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other non-job related characteristics or other prohibited grounds by applicable laws. Reasonable accommodation is available for applicants protected by Section 503 of the Rehabilitation Act, the Vietnam Era Veterans\' Readjustment Act, and the Americans with Disabilities Act. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Current Gilead employees and contractors: please apply via the Internal Career Opportunities portal in Workday.
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