Executive Director, Global Project Leader

Overview

The Global Project Leader provides strategic and operational leadership for one or more global clinical development programs within a complex, global rare disease portfolio, spanning early development through registration and lifecycle management. The role drives integrated program strategy, execution, and decision-making within a global, matrixed governance model, partnering closely with cross‑functional and headquarters stakeholders. The Global Project Leader is accountable for shaping strategic recommendations, enabling high‑quality governance, and ensuring delivery of program objectives aligned with portfolio priorities and long‑term patient impact.

This role is critical to ensuring that Shionogi’s rare disease portfolio is advanced with agility, rigor, and long‑term patient impact in mind.

• Lead global, cross‑functional program teams across the full development lifecycle (early, late, registration, lifecycle management) for rare disease assets.
• Define and drive integrated program strategies aligned with clinical, regulatory, CMC, and commercial objectives.
• Contribute to rare disease portfolio strategy, including prioritization, sequencing, and portfolio trade‑off decisions across programs.
• Translate complex scientific, clinical, and regulatory data into clear strategic options and decision frameworks for senior leadership.
• Serve as a core leader in governance forums, delivering high‑quality, decision‑ready materials aligned with enterprise priorities.
• Drive structured, transparent decision‑making across global stakeholders within a matrixed governance model, including close partnership with headquarters.
• Oversee integrated development plans, critical milestones, and cross‑functional execution to ensure delivery against strategic objectives.
• Ensure accountability, execution discipline, and proactive resolution of risks impacting timelines, quality, or program viability.
• Lead lifecycle management strategy, including label expansion, geographic expansion, and integration of real‑world evidence.
• Identify, assess, and mitigate program and portfolio risks; lead scenario planning and complex trade‑off decisions under uncertainty, including challenges specific to rare disease development.
• Accountable for program‑level resource planning, financial assumptions, and alignment with portfolio investment priorities.
• Influence and align global cross‑functional stakeholders across regions (U.S., EU, APAC) and external partners (e.g., regulators, KOLs, advocacy groups) to advance program objectives.
• Mentor and develop talent, and drive continuous improvement in program leadership capabilities, tools, and operating model effectiveness.
• Other duties as assigned.

• Bachelor’s degree required; advanced degree (PhD, PharmD, MD, MS, MBA) strongly preferred.
• 12+ years of experience in pharmaceutical/biotechnology development with demonstrated leadership in global, cross‑functional settings; experience in rare disease development strongly preferred.
• Demonstrated experience across multiple phases of drug development, with strong understanding of the end‑to‑end development lifecycle, including regulatory pathways.
• Proven ability to drive program strategy and execution in matrixed organizations and within structured governance models.
• Strong track record of engaging and influencing senior leadership; ability to synthesize complexity into clear decision options and recommendations.
• Experience working effectively with external stakeholders (e.g., regulators, KOLs, advocacy groups, partners) in a compliant and coordinated manner.
• Demonstrated ability to operate with portfolio‑level thinking and to transition across indications/programs as portfolio needs evolve.
• Proven ability to mentor and develop program/project management talent and contribute to building organizational capability.

• Experience leading development programs in highly complex, rapidly evolving rare neurodegenerative diseases with substantial scientific, clinical, and regulatory uncertainty.
• Broader experience in rare disease / orphan drug development and/or specialty therapeutics.
• Experience with post‑approval LCM…