Director, CMC Portfolio Operations and Insights
Gilead Sciences
6 days ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Director, CMC Portfolio Operations and Insights
Key Responsibilities
Strategic Pipeline Oversight & Coordination
- Own and evolve end-to-end portfolio visibility and insights strategy across the CMC regulatory pipeline.
- Provide integrated, forward-looking views of CMC regulatory activities across development and commercial lifecycle stages aligned to regulatory milestones and business objectives.
- Translate multi-program dependencies into executive-level insights and recommendations for prioritization, trade-offs, and resource allocation.
- Develop and maintain consolidated operational views of regulatory deliverables to support long-range planning, forecasting, and capacity management (e.g., Planisware).
- Partner with CMC Regulatory Leads to anticipate resource needs, identify risks, and proactively resolve schedule conflicts/bottlenecks.
- Lead portfolio-level risk management frameworks to identify, assess, and mitigate risks.
- Identify cross-program dependencies and operational impacts; influence execution and regulatory planning.
- Facilitate program/portfolio reviews with concise executive communications and recommendations.
- Drive annual and long-range operational planning (capacity modeling, headcount forecasting, workload analysis).
Operational and Digital Excellence
- Identify process gaps; implement improvement roadmaps with measurable outcomes.
- Drive adoption of enabling technologies, digital tools, and analytics to modernize operations and reduce manual burden.
- Establish performance metrics, dashboards, and reporting for portfolio health, submission readiness, and execution risk.
- Enhance governance/operational review processes; standardize best practices for scalability, efficiency, and transparency.
- Partner on enterprise process optimization, data governance, and operational intelligence initiatives.
- Contribute to evolution of CMC RA policies/frameworks/governance models; drive innovation/continuous improvement.
Leadership, Stakeholder Engagement, and Influencing
- Provide strategic/operational leadership, mentorship, and direction to teams.
- Lead through influence across senior regulatory, technical, and business stakeholders.
- Build cross-functional relationships; foster accountability, transparency, and trust.
- Influence senior leadership decisions in complex/ambiguous environments.
- Represent portfolio insights, risks, and recommendations via clear, data-driven executive communications.
- Champion continuous improvement, innovation, and operational excellence; lead/contribute to strategic initiatives.
Qualifications
- 12+ years with BA/BS (Life Sciences, Engineering, or related); 10+ years with MA/MS/MBA; 8+ years with PharmD/PhD.
- Demonstrated ownership of strategy/execution for complex portfolios/programs/regulatory operations at scale.
- Extensive CMC/Regulatory Affairs experience in biopharma; experience across development and marketed products and regulatory submissions across lifecycle stages.
- Understanding of global CMC regulatory requirements (FDA, EMA, ICH) and drug development lifecycle.
- Proven ability to drive functional/enterprise process improvement and operational change.
- Exceptional organizational, communication, and stakeholder management skills; ability to influence at all levels.
- Strong analytical/problem-solving skills; translate complex data into executive insights.
- Proven ability to lead direct or matrix teams across cross-functional stakeholders.
- Preferred: digital transformation/operational excellence/non-product initiatives.
- Preferred: Veeva infrastructure (Vault RIM), vendor management, PMP certification.
Benefits/Compensation
- Salary range: $210,375.00 - $272,250.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities
Strategic Pipeline Oversight & Coordination
- Own and evolve end-to-end portfolio visibility and insights strategy across the CMC regulatory pipeline.
- Provide integrated, forward-looking views of CMC regulatory activities across development and commercial lifecycle stages aligned to regulatory milestones and business objectives.
- Translate multi-program dependencies into executive-level insights and recommendations for prioritization, trade-offs, and resource allocation.
- Develop and maintain consolidated operational views of regulatory deliverables to support long-range planning, forecasting, and capacity management (e.g., Planisware).
- Partner with CMC Regulatory Leads to anticipate resource needs, identify risks, and proactively resolve schedule conflicts/bottlenecks.
- Lead portfolio-level risk management frameworks to identify, assess, and mitigate risks.
- Identify cross-program dependencies and operational impacts; influence execution and regulatory planning.
- Facilitate program/portfolio reviews with concise executive communications and recommendations.
- Drive annual and long-range operational planning (capacity modeling, headcount forecasting, workload analysis).
Operational and Digital Excellence
- Identify process gaps; implement improvement roadmaps with measurable outcomes.
- Drive adoption of enabling technologies, digital tools, and analytics to modernize operations and reduce manual burden.
- Establish performance metrics, dashboards, and reporting for portfolio health, submission readiness, and execution risk.
- Enhance governance/operational review processes; standardize best practices for scalability, efficiency, and transparency.
- Partner on enterprise process optimization, data governance, and operational intelligence initiatives.
- Contribute to evolution of CMC RA policies/frameworks/governance models; drive innovation/continuous improvement.
Leadership, Stakeholder Engagement, and Influencing
- Provide strategic/operational leadership, mentorship, and direction to teams.
- Lead through influence across senior regulatory, technical, and business stakeholders.
- Build cross-functional relationships; foster accountability, transparency, and trust.
- Influence senior leadership decisions in complex/ambiguous environments.
- Represent portfolio insights, risks, and recommendations via clear, data-driven executive communications.
- Champion continuous improvement, innovation, and operational excellence; lead/contribute to strategic initiatives.
Qualifications
- 12+ years with BA/BS (Life Sciences, Engineering, or related); 10+ years with MA/MS/MBA; 8+ years with PharmD/PhD.
- Demonstrated ownership of strategy/execution for complex portfolios/programs/regulatory operations at scale.
- Extensive CMC/Regulatory Affairs experience in biopharma; experience across development and marketed products and regulatory submissions across lifecycle stages.
- Understanding of global CMC regulatory requirements (FDA, EMA, ICH) and drug development lifecycle.
- Proven ability to drive functional/enterprise process improvement and operational change.
- Exceptional organizational, communication, and stakeholder management skills; ability to influence at all levels.
- Strong analytical/problem-solving skills; translate complex data into executive insights.
- Proven ability to lead direct or matrix teams across cross-functional stakeholders.
- Preferred: digital transformation/operational excellence/non-product initiatives.
- Preferred: Veeva infrastructure (Vault RIM), vendor management, PMP certification.
Benefits/Compensation
- Salary range: $210,375.00 - $272,250.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.