Senior Director, Project Leader(Immunology and Respiratory Therapeutic Area)) (United States)

The Company

Ailux is an innovative biotechnology company focused on discovering and developing next-generation biologic therapeutics for chronic respiratory and immunological diseases with high unmet medical need. The company integrates advanced computational approaches with rigorous experimental and translational science across the drug discovery continuum, enabling faster and more informed decision-making from target identification through clinical candidate selection.

As an AI-native biotech and a subsidiary of XtalPi, Ailux combines proprietary computational models with state-of-the-art wet lab capabilities to design differentiated therapeutics against challenging biological targets. The company has established strategic partnerships with leading pharmaceutical organisations, providing external validation of its scientific platform and discovery capabilities. Looking ahead, Ailux’s vision is to build a fully integrated, end-to-end drug discovery and development organisation capable of delivering the next generation of medicines for patients with chronic respiratory and immunological diseases. By combining advanced AI capabilities with deep biological, translational and clinical insight, the company aims to accelerate the development of differentiated therapeutics with meaningful impact for patients worldwide.

Backed by an experienced leadership team, leading scientific advisors and a highly multidisciplinary organisation, Ailux is approaching a key inflection point as its first wave of therapeutic programmes advances toward clinical development. This is an opportunity to help shape the scientific foundations, pipeline and culture of a rapidly growing biotechnology company operating at the intersection of AI, translational science and next-generation therapeutics.

The Role

We are seeking an accomplished and strategic Project Leader to lead multiple pre-IND programs in the field of immune-mediated and respiratory diseases. Reporting to the VP, Head of Biology R&D, Respiratory & Immunology, this individual will play a pivotal role in advancing preclinical candidates through IND-enabling studies, regulatory submission, and early clinical development while shaping indication strategy, lifecycle management opportunities, and future portfolio growth.

The successful candidate will lead cross-functional matrix teams across respiratory and immunology portfolio, driving rapid, data-driven progression of novel biologics and multispecific antibody therapeutics from candidate selection through IND and into the clinic. This role is responsible for aligning scientific, translational, regulatory, CMC, clinical, and operational functions to deliver program milestones on time and with excellence.

Working at the intersection of AI-driven drug discovery, computational biology, disease biology, and translational and clinical science, you will ensure that deep biological insights, differentiation strategies, and disease relevance are embedded into program progression, development recommendations and portfolio decisions. You will have significant influence on program prioritization, development strategy, and portfolio evolution, helping unlock the full potential of AI-enabled drug discovery.

Key Responsibilities

Scientific & Program Leadership

• Lead cross-functional teams through IND-enabling activities, IND submissions, and early clinical development.
• Develop and execute 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.

Cross-Functional Collaboration

• Partner closely with Biology, AI Drug Design, Protein Engineering, Translational Sciences, Toxicology, CMC, Regulatory Affairs, and Clinical Development teams to deliver integrated development strategies.
• Facilitate alignment across internal functions and external partners to ensure efficient program execution.
• Identify, select, and manage CROs, academic collaborators, and strategic partners.
• Represent program and immunology expertise in portfolio reviews, governance forums, and external interactions.
• Champion data-driven decision-making and leverage AI-enabled insights to accelerate drug discovery and development.

Qualifications & Experience

• PhD, MD, or equivalent advanced degree in Immunology, Biology, Pharmacology, or a related scientific discipline
• >7 years of biopharmaceutical industry experience in immunology and/or respiratory R&D
• Proven experience leading IND-enabling programs and supporting or leading IND submissions
• Strong understanding of drug discovery and development, translational medicine, FDA regulations, and global regulatory requirements
• Understanding of immune-mediated and/or respiratory diseases, demonstrated experience in development of therapies for immune-mediated and/or respiratory diseases
• Demonstrated success leading complex cross-functional programs in a matrix environment
• Experience advancing biologics and/or multispecific antibody therapeutics is preferred
• Exceptional leadership, communication, stakeholder management, and problem-solving skills

Key Competencies

• Strategic leadership and execution
• Cross-functional influence and matrix leadership
• Drug development and regulatory expertise
• Risk assessment and issue resolution
• Budget, resource, and vendor management
• Executive communication and stakeholder engagement
• Scientific judgment and data-driven decision-making
• Ability to influence without direct authority
• Entrepreneurial mindset and ability to thrive in a fast-paced biotech environment
• Passion for leveraging AI, computational biology, and innovative technologies to R&D

Location: United States (Remote)

Travel: International travel required.