Director, CMC Portfolio Operations and Insights

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

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Job Description

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.

Key responsibilities:

Strategic Pipeline Oversight & Coordination

• 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 Gileads 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.

Operational and Digital Excellence

• 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.

Leadership Stakeholder Engagement and Influencing

• 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.

Qualifications

• 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.

• Experience in digital transformation operational excellence or non-product initiatives preferred.

• Experience with Veeva infrastructure (Vault RIM) vendor management and PMP certification preferred.

The salary range for this position is: $210375.00 - $272250.00. Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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Please apply via the Internal Career Opportunities portal in Workday.