Executive Director, Global Project Leader
Shionogi Inc. (U.S.) · Florham Park, NJ · 3 wk ago
HybridInformation Technology$285k–$315k/yrFull-time
Responsibilities
- 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
- 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: Leading development programs in highly complex, rapidly evolving rare neurodegenerative diseases with substantial scientific, clinical, and regulatory uncertainty.
- PREFERRED: Broader experience in rare disease / orphan drug development and/or specialty therapeutics.
- PREFERRED: Experience with post-approval LCM (label expansion, RWE integration, lifecycle value planning).
- PREFERRED: Experience collaborating with headquarters-led decision-making structures in a global organization.
- PREFERRED: Operates within a matrixed global governance model where decision authority is shared; accountable for shaping recommendations, driving alignment, and ensuring execution against agreed decisions.
- PREFERRED: Ability and willingness to travel approximately 25–35% of the year both domestically and internationally.