The Director, Submission Project Management serves as the strategic and operational leader accountable for planning, integrating, and executing activities that enable successful major regulatory submissions, including BLAs, sBLAs, and global regulatory filings.

This role provides leadership across Clinical Development, Clinical Operations, Data Management, Biostatistics, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, Safety, Quality, and other cross-functional teams to ensure submission readiness, operational excellence, and achievement of critical filing milestones.

The Director leads integrated planning and execution from clinical data generation through regulatory submission, driving alignment across functional deliverables, critical dependencies, risks, and timelines. As a trusted partner to Development and Regulatory leadership, this individual provides strategic guidance, enables informed decision-making, and fosters organizational alignment to support timely, high-quality regulatory outcomes.

While regulatory submission planning and execution remain the primary focus, this role may also provide project management leadership for select Development initiatives, including process improvement efforts, Product Team support, and Development sub-team planning and execution, as business priorities require.

Job Responsibilities

Submission Strategy & Leadership

• Accountable for end-to-end oversight of clinical trial data readiness to support BLA, sBLA, and other major global regulatory filings.

• Develop and drive integrated submission strategies that align clinical, operational, data, regulatory, and functional activities required for successful filings.

• Serve as the senior operational lead for submission planning, execution, and readiness across cross-functional development teams, with the ability to flex into broader Global Project Manager accountabilities as portfolio and business priorities require.

• Partner with Development and Regulatory leadership to establish filing strategies, key milestones, risk mitigation plans, and execution priorities.

• Ensure cross-functional alignment on submission objectives, assumptions, dependencies, and critical decisions throughout the filing lifecycle.

Clinical Trial Data Readiness & Execution

• Lead the development and execution of integrated, cross-functional plans to ensure timely delivery of clinical trial data required to support major regulatory submissions.

• Drive end-to-end coordination of critical submission deliverables, ensuring key milestones, dependencies, and outputs are identified, sequenced, tracked, and executed in alignment with filing objectives, including database lock, data review activities, statistical analyses, CSR inputs, and regulatory submission components.

• Conduct comprehensive readiness assessments to evaluate clinical data maturity, submission preparedness, critical risks, and mitigation strategies, enabling proactive issue resolution and informed decision-making.

• Establish and maintain visibility into submission timelines, key dependencies, performance metrics, and execution risks to support effective governance, accelerate decision-making, and enhance submission predictability.

• Partner across Development, Biometrics, Regulatory, and other functional teams to ensure alignment, accountability, and execution excellence throughout the submission lifecycle.

Timeline Acceleration & Operational Excellence

• Lead critical-path planning and execution across the regulatory submission lifecycle, ensuring seamless integration from clinical data generation through regulatory filing.

• Analyze submission cycle times and identify opportunities to accelerate delivery through process optimization, strategic planning, governance enhancements, and streamlined cross-functional decision-making.

• Drive initiatives to reduce overall time-to-filing while maintaining the highest standards of quality, inspection readiness, and regulatory compliance.

• Develop and implement performance metrics, dashboards, and forecasting tools to monitor submission progress, identify emerging risks, and measure the impact of cycle-time improvement initiatives.

• Establish data-driven governance processes that provide transparency into key milestones, dependencies, resource needs, and execution risks.

• Drive continuous improvement across submission planning methodologies, governance structures, and execution practices.

Cross-Functional Leadership & Influence

• Foster accountability and alignment across highly matrixed teams without direct reporting authority.

• Facilitate effective decision-making by bringing clarity to complex issues, priorities, dependencies, and competing demands.

• Build strong partnerships across Development to enhance execution effectiveness and organizational agility.

• Develop executive-ready communications, dashboards, analyses, and recommendations for senior leadership and governance committees.

Organizational Capability Building

• Define and standardize submission planning frameworks, processes, tools, and best practices.

• Establish scalable approaches that improve submission predictability and execution consistency.

• Mentor project management talent and contribute to broader operational excellence and submission management capabilities.

• Lead strategic initiatives focused on transforming submission execution and reducing time from clinical data availability to regulatory filing.

Broader Development Project Management Support

• Provide targeted Global Project Manager support to Product Teams and Development sub-teams as needed.

• Oversee process improvement work streams that strengthen planning, governance, decision-making, communication, and operational execution across Development.

Basic Requirements

• Doctorate + 6 years of pharmaceutical/biotech or relevant industry experience

• Master's + 10 years

• Bachelor's + 12 years

Preferred Qualifications

• Extensive pharmaceutical or biotechnology industry experience supporting late-stage development and major regulatory submissions.

• Demonstrated success leading complex regulatory filing initiatives, including BLAs, sBLAs, NDAs, MAAs, or equivalent global submissions.

• Deep understanding of clinical trial execution, clinical data generation, data review, data management, statistical analysis, medical writing, safety, quality, and regulatory submission processes.

• Proven track record of leading large-scale, cross-functional initiatives and influencing senior leadership in a matrixed organization.

• Experience as a Global Project Manager, program lead, or equivalent operational.

• Ability to flex between submission execution, process improvement, and broader Development project management accountabilities while maintaining clear prioritization and leadership alignment.

• Strong executive presence with the ability to communicate complex issues, strategic trade-offs, and recommendations to senior leadership.

• Demonstrated success leading continuous improvement initiatives.

• Ability to translate detailed submission execution plans into clear, decision-oriented leadership communications.

• Oncology, hematology, cell therapy, or advanced therapeutics experience strongly preferred.

• Experience with enterprise portfolio, timeline, submission planning, clinical data, governance, or project management tools preferred.

• PMP, operational excellence, Lean Six Sigma, or related certification preferred.

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is:

Kite 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.