Global Project Lead

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Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type:
Permanent

Location:

Boston, MA, US

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas:AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.

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…