Director, CMC Portfolio Operations and Insights
Gilead Sciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Director, CMC Portfolio Operations and Insights
Key Responsibilities:
- Own and evolve end-to-end CMC portfolio visibility and insights strategy across the regulatory pipeline.
- Provide an integrated, forward-looking view across development and commercial lifecycle stages aligned to milestones and business objectives.
- Translate multi-program dependencies into executive insights to enable prioritization, trade-offs, and resource allocation.
- Maintain consolidated views of regulatory deliverables to support long-range planning, forecasting, and capacity management (e.g., Planisware).
- Partner with CMC Regulatory Leads to anticipate resources, resolve schedule conflicts/bottlenecks, and lead portfolio-level risk management frameworks.
- Identify cross-program dependencies/operational impacts; facilitate program/portfolio reviews with executive communications.
- Drive annual/long-range operational planning (capacity modeling, headcount forecasting, workload analysis).
Operational and Digital Excellence:
- Identify process gaps; implement measurable improvement roadmaps.
- Drive adoption of digital tools/analytics to reduce manual burden.
- Establish performance metrics, dashboards, and reporting for portfolio health and execution risk.
- Standardize governance, processes, and best practices; align with PDM Strategy & Operations on process optimization and data governance.
Leadership & Stakeholders:
- Provide strategic/operational leadership, mentorship, and influence across senior stakeholders and cross-functional partners.
Qualifications:
- 12+ years (BA/BS Life Sciences/Engineering or related), or 10+ (MA/MS/MBA), or 8+ (PharmD/PhD).
- Experience owning strategy/execution for complex portfolios or regulatory operations at scale.
- Extensive CMC/Regulatory Affairs experience in biopharma; regulatory submissions across lifecycle stages.
- Knowledge of global CMC requirements (FDA, EMA, ICH) and drug development lifecycle.
- Proven process improvement and operational change; strong analytics, communication, and stakeholder management.
- Preferred: digital transformation/operational excellence; experience with Veeva (Vault RIM), vendor management, PMP certification.
Benefits:
- Eligibility for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance plans (as part of the job description).
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities:
- Own and evolve end-to-end CMC portfolio visibility and insights strategy across the regulatory pipeline.
- Provide an integrated, forward-looking view across development and commercial lifecycle stages aligned to milestones and business objectives.
- Translate multi-program dependencies into executive insights to enable prioritization, trade-offs, and resource allocation.
- Maintain consolidated views of regulatory deliverables to support long-range planning, forecasting, and capacity management (e.g., Planisware).
- Partner with CMC Regulatory Leads to anticipate resources, resolve schedule conflicts/bottlenecks, and lead portfolio-level risk management frameworks.
- Identify cross-program dependencies/operational impacts; facilitate program/portfolio reviews with executive communications.
- Drive annual/long-range operational planning (capacity modeling, headcount forecasting, workload analysis).
Operational and Digital Excellence:
- Identify process gaps; implement measurable improvement roadmaps.
- Drive adoption of digital tools/analytics to reduce manual burden.
- Establish performance metrics, dashboards, and reporting for portfolio health and execution risk.
- Standardize governance, processes, and best practices; align with PDM Strategy & Operations on process optimization and data governance.
Leadership & Stakeholders:
- Provide strategic/operational leadership, mentorship, and influence across senior stakeholders and cross-functional partners.
Qualifications:
- 12+ years (BA/BS Life Sciences/Engineering or related), or 10+ (MA/MS/MBA), or 8+ (PharmD/PhD).
- Experience owning strategy/execution for complex portfolios or regulatory operations at scale.
- Extensive CMC/Regulatory Affairs experience in biopharma; regulatory submissions across lifecycle stages.
- Knowledge of global CMC requirements (FDA, EMA, ICH) and drug development lifecycle.
- Proven process improvement and operational change; strong analytics, communication, and stakeholder management.
- Preferred: digital transformation/operational excellence; experience with Veeva (Vault RIM), vendor management, PMP certification.
Benefits:
- Eligibility for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance plans (as part of the job description).
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.