Senior Project Leader, Immunology & Respiratory Biologics

Ailux; Greater London; Sur place; GBP 180 000 - 240 000; Plein temps

Résumé du poste

Ailux, a cutting-edge biotechnology company, seeks an accomplished Project Leader to guide multiple pre-IND programs in immune-mediated and respiratory diseases. You will coordinate across biology, AI design, and regulatory teams to advance candidates through IND-enabling studies toward early clinical development.

The role requires a PhD/MD or equivalent, 7+ years in biopharma, and a track record of IND submissions.

Qualifications

• PhD, MD, or equivalent advanced degree in Immunology, Biology, Pharmacology, or related field.
• >7 years 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.
• Experience advancing biologics and/or multispecific antibody therapeutics is preferred.

Responsabilités

• Lead cross-functional matrix 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 address scientific, operational, and regulatory risks.
• Ensure compliance with regulatory requirements, quality standards, and company policies.
• Provide program updates and decisions to senior leadership and governance committees.
• Partner with Biology, AI Drug Design, Protein Engineering, Translational Sciences, Toxicology, CMC, Regulatory Affairs, and Clinical Development teams to deliver integrated strategies.
• Identify, select, and manage CROs, academic collaborators, and strategic partners.
• Champion data-driven decision-making and leverage AI-enabled insights to accelerate drug discovery and development.

Connaissances

Strategic leadership

Cross-functional leadership

Executive communication

Regulatory understanding

Program management

Stakeholder management

Data-driven decisions

Biopharma experience

Formation

PhD/MD or equivalent

Description du poste

Ailux, a cutting-edge biotechnology company, seeks an accomplished Project Leader to guide multiple pre-IND programs in immune-mediated and respiratory diseases. You will coordinate across biology, AI design, and regulatory teams to advance candidates through IND-enabling studies toward early clinical development.

The role requires a PhD/MD or equivalent, 7+ years in biopharma, and a track record of IND submissions.