Strategic Project Leader, Immunology & Respiratory

AiLux S.r.l.; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

AiLux S.r.l. seeks an accomplished Project Leader to steer multiple pre-IND programs in immune-mediated and respiratory diseases.

Reporting to VP, Head of Biology R&D, this role drives IND-enabling studies, regulatory submissions, and early clinical development while shaping indication strategy and portfolio growth. You will lead cross-functional teams across respiratory and immunology, align scientific, translational, regulatory, CMC, and clinical functions to deliver milestones on time with

Qualifications

• PhD, MD, or equivalent advanced degree in Immunology, Biology, Pharmacology, or related field.
• >7 years of biopharmaceutical industry experience in immunology and/or respiratory R&D.
• Proven experience leading IND-enabling programs and IND submissions.
• Strong understanding of FDA regulations and global regulatory requirements.
• Experience with biologics and multispecific antibody therapeutics is preferred.
• Excellent leadership, communication, and stakeholder management skills.
• Strategic leadership with execution and matrix leadership experience.
• Ability to influence without direct authority in a fast-paced biotech.

Responsibilities

• Lead cross-functional teams through IND-enabling activities and early clinical development.
• Develop integrated program strategies, timelines, milestones, budgets, and risk mitigation plans.
• Drive scientific and development decisions that maximize program differentiation, value creation, and probability of success.
• Oversee preparation and review of IND/CTA submissions, regulatory briefing materials, and health authority responses.
• Monitor program progress and proactively address scientific, operational, and regulatory risks.
• Ensure compliance with applicable regulatory requirements, quality standards, and company policies.
• Provide clear program updates, recommendations, and decision points to senior leadership and governance committees.

Skills

Leadership

Cross-functional leadership

Program management

Regulatory knowledge

Strategic thinking

Stakeholder management

Decision making

Communication

Problem solving

Entrepreneurial mindset

Education

PhD, MD, or equivalent

Job description

AiLux S.r.l. seeks an accomplished Project Leader to steer multiple pre-IND programs in immune-mediated and respiratory diseases.

Reporting to VP, Head of Biology R&D, this role drives IND-enabling studies, regulatory submissions, and early clinical development while shaping indication strategy and portfolio growth. You will lead cross-functional teams across respiratory and immunology, align scientific, translational, regulatory, CMC, and clinical functions to deliver milestones on time with