Global Project Lead

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type:
Permanent

Location:

United States, US

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 7,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

The Global Project Leader (GPL) leads the Core Project Team and is responsible for defining the vision, strategy, and integrated project plan for research platforms in gene therapy and gene editing. The GPL ensures the progression of research candidates through translational development up to IND submission and start of clinical development. The role requires deep scientific expertise, strategic leadership, and cross‑functional coordination to drive innovation and deliver on project milestones.

The ideal candidate can reside anywhere in the US (with preference for ET time zone) or Europe.

• Authority: Authorize project activities between Stage‑Gates within agreed budget, timelines, and quality parameters.
• Strategy: Lead the Core Project Team to deliver project objectives, ensuring alignment with strategic goals. Drive candidate selection and progression through preclinical development, IND‑enabling studies, and transition to clinical phases.
• Key Project Documents: Ensure timely updates of TCP, TPP, Integrated Project Plan (PDP and Gantt), Project Card, and Risk Log at each Stage‑Gate and upon significant scope changes.
• Teamwork / Leadership of Core Team: Foster a collaborative, empowered, and innovative team environment. Coach Extended Team Leaders to support functional team autonomy and accountability. Guide the team through interactions with regulatory authorities, investigators, and scientific experts.
• Risk Management: Develop and maintain risk mitigation plans, updated at least annually and at each Stage‑Gate.
• Communication: Develop and maintain an integrated communication plan addressing scientific, IP, commercial, and reputational aspects. Represent the project at internal governance bodies and external scientific forums. Ensure timely and transparent communication with senior management and governance bodies regarding project scope changes.
• Stakeholder Management: Implement robust internal and external stakeholder engagement strategies.

• Minimum 10 years in the pharmaceutical or biotech industry, with a focus on translational science and gene therapy/editing.
• Proven track record in advancing research candidates to IND and clinical development.
• Experience in leading cross‑functional teams and managing complex R&D projects.
• Deep scientific knowledge in gene therapy and gene editing technologies.
• Strong understanding of translational development, regulatory pathways, and IND‑enabling requirements.
• Familiarity with project planning tools and matrix organizational structures.
• Demonstrated leadership and strategic thinking.
• Excellent interpersonal, communication, facilitation, and presentation skills.

Master’s degree and PhD in a relevant scientific discipline (e.g., Molecular Biology, Biotechnology, Medicine).

The annual base pay for this position ranges from $183,600 to $224,400. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base…