Executive Director, Global Project Leader

Shionogi Inc. (U.S.)

Global Project Leader providing strategic leadership for global clinical development programs within a rare disease portfolio. Managing program strategies and execution while partnering with cross-functional teams.

Posted 5/29/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesSenior💰 $285,000 - $315,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

EEO Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, or any other characteristic protected by applicable law.

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Hard Skills & Tools

program managementdrug developmentregulatory pathwaysportfolio managementrisk assessmentfinancial planninglifecycle managementscenario planningcross-functional executiondecision-making frameworks

Soft Skills

leadershipinfluencingmentoringcommunicationstrategic thinkingproblem-solvingcollaborationaccountabilityadaptabilitycontinuous improvement

Certifications

Bachelor's degreePhDPharmDMDMSMBA