Director, Regulatory Submissions & Cross‑Functional Lead

Kite Pharma; Parsippany-Troy Hills (NJ); Vor Ort; USD 206.000 - 266.000; Vollzeit

Zusammenfassung

Kite Pharma in the United States seeks a Director, Submission Project Management to lead strategic and operational planning for major regulatory submissions (BLAs, sBLAs, NDAs) across Clinical Development, Regulatory Affairs, Data Management, and Biostatistics.

The role ensures cross-functional alignment, drives timelines, assesses risks, and optimizes submission readiness while fostering organizational capability and execution excellence.

Qualifikationen

• Doctorate + 6 years of pharmaceutical/biotech or relevant industry experience.
• Master's + 10 years of experience in development and regulatory submissions.
• Bachelor's + 12 years of experience in project management and development.

Aufgaben

• 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.
• 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.
• 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, 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.
• 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.
• 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.
• 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.

Kenntnisse

Submission planning

Cross-functional leadership

Regulatory submissions

Clinical data readiness

Project management

Biotech/pharma industry

Ausbildung

Pharma/biotech doctorate

Master's degree

Bachelor's degree

Tools

PMP Certification

Lean Six Sigma

Jobbeschreibung

Kite Pharma in the United States seeks a Director, Submission Project Management to lead strategic and operational planning for major regulatory submissions (BLAs, sBLAs, NDAs) across Clinical Development, Regulatory Affairs, Data Management, and Biostatistics.

The role ensures cross-functional alignment, drives timelines, assesses risks, and optimizes submission readiness while fostering organizational capability and execution excellence.