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 Shionogis rare disease portfolio is advanced with agility rigor and long-term patient impact in mind.

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.
• Other duties as assigned.

Minimum Job Requirements:

• Bachelors 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 2535% 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 $285000 - $315000. 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.

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 (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to