Director, Submission Project Management Lead

About this role

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

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 i

Similar jobs

• Director, Global Submission Management — Vertex · Boston, MA
• Associate Director, Global Submission Management — Vertex · Boston, MA
• Director, Project Management — KION Group · Grand Rapids, MI | Henrietta, NY | Atlanta, GA
• Director, Project Management — Cognite · USA (Houston); USA (Phoenix)
• Director, Project Management — Djeholdings (ZenoCareers) · Chicago, Illinois, United States
• Director, Project Management — Cgc · San Francisco, CA
• Director, Project Management — S&P Global · New York, NY
• Director, Project Management — "Gilead Sciences · Foster City, California, United States