Director, CMC Portfolio Operations and Insights

Gilead Sciences•Foster City, CA

1d•$210,375 - $272,250

About The Position

Gilead is seeking a Director, CMC Portfolio Operations and Insights to lead and set the strategy for a CMC RA portfolio operations capability, driving enterprise-level visibility, prioritization, and proactive risk management across a specific platform (SM, LM, Device). This role functions as a strategic leader within CMC Regulatory Affairs, with accountability for shaping how portfolio insights inform global regulatory strategy, planning, and execution across multiple products and lifecycle stages, including high-priority and high-visibility programs. Serving as a critical strategic partner to CMC RA leadership, this individual will influence decision-making by ensuring seamless execution, resource alignment, and continuous improvement of CMC regulatory processes across development and commercial programs. Reporting to the Head of CMC Regulatory Affairs Strategy and Operations, this role will play a central leadership role in advancing operational excellence, digital innovation, and data-driven decision-making across the CMC RA function.

Requirements

12+ years with BA/BS in Life Sciences, Engineering, or related field; 10+ years with MA/MS/MBA; 8+ years with PharmD/PhD.
Demonstrated experience owning strategy and execution for complex portfolios, programs, or regulatory operations at scale.
Extensive experience in CMC, Regulatory Affairs, or related functions within the biopharma industry.
Significant experience supporting development and marketed products, including regulatory submissions across lifecycle stages.
Understanding of CMC regulatory requirements across global health authorities (FDA, EMA, ICH guidelines) and the drug development lifecycle.
Proven ability to drive process improvement and operational change at a functional or enterprise level.
Exceptional organizational, communication, and stakeholder management skills with the ability to influence at all levels of the organization, inc to drive decisions in complex or ambiguous environments.
Strong analytical and problem-solving skills, with the ability to translate complex data into clear executive-level insights.
Proven ability to lead through direct or matrix teams and across cross-functional stakeholders.

Nice To Haves

Experience in digital transformation, operational excellence, or non-product initiatives preferred.
Experience with Veeva infrastructure (Vault RIM), vendor management, and PMP certification preferred.

Responsibilities

Own and evolve the end-to-end portfolio visibility and insights strategy across the CMC regulatory pipeline.
Provide an integrated, forward-looking view of CMC regulatory activities across development and commercial lifecycle stages, aligned with regulatory milestones and business objectives.
Translate complex multi-program dependencies into clear executive-level insights and recommendations, enabling prioritization, trade-off decisions, and resource allocation.
Develop and maintain a consolidated operational view of regulatory deliverables to support long-range planning, forecasting, and capacity management. This may include resource management as defined in Gilead’s resource forecasting system (i.e., Planisware).
Partner with CMC Regulatory Leads to anticipate resource needs, identify risks, and proactively resolve schedule conflicts and bottlenecks.
Lead portfolio-level risk management, establishing frameworks to identify, assess, and mitigate risks across programs.
Identify cross-program dependencies and operational impacts, influencing execution strategies and regulatory planning.
Facilitate program and portfolio reviews, delivering concise, executive-level communications and recommendations.
Drive annual and long-range operational planning, including capacity modeling, headcount forecasting, and workload analysis.
Identify systemic process gaps and inefficiencies; define and implement improvement roadmaps with measurable outcomes.
Drive adoption of enabling technologies, digital tools, and analytics capabilities to modernize CMC regulatory operations and reduce manual burden.
Establish and maintain performance metrics, dashboards, and reporting frameworks providing real-time insight into portfolio health, submission readiness, and execution risk.
Lead and continuously enhance governance and operational review processes, ensuring effective decision-making across complex portfolios and evolving environments.
Standardize processes and best practices to improve scalability, efficiency, and transparency across the CMC RA function.
Partner with PDM Strategy & Operations and other functions to align on enterprise-wide process optimization, data governance, and operational intelligence initiatives.
Contribute to the development and evolution of CMC RA policies, frameworks, and governance models, with impact beyond immediate scope.
Drive innovation and continuous improvement across processes, tools, and ways of working.
Provide strategic and operational leadership, mentorship, and direction to team members and/or matrix teams, setting direction and elevating performance standards.
Lead through influence across a broad and senior stakeholder landscape, including regulatory, technical, and business leadership.
Build strong collaborative relationships across the CMC RA organization and with cross-functional partners, fostering a culture of accountability, transparency, and trust.
Influence senior leadership decision-making, particularly in complex or ambiguous environments where guidance may be limited.
Represent portfolio insights, risks, and recommendations to senior leaders through clear, compelling, and data-driven executive communications.
Champion a culture of continuous improvement, innovation, and operational excellence.
Lead or contribute to strategic initiatives that advance CMC RA capabilities, infrastructure, and organizational effectiveness.