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.

Preferred

• 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 (label expansion, RWE integration, lifecycle value planning).
• Experience collaborating with headquarters-led decision-making structures in a global organization.
• Operates within a matrixed global governance model where decision authority is shared; accountable for shaping recommendations, driving alignment, and ensuring execution against agreed decisions.
• Ability and willingness to travel approximately 25–35% of the year both domestically and internationally.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month.

Additional Information

The base salary range for this full-time position is $285,000 - $315,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.