Global Project Leader, Biotech — Preclinical to PoC

AiLux S.r.l.; Cambridge; On-site; GBP 120,000 - 180,000; Full time

Job summary

Ailux is seeking a Global Project Leader to own the integrated strategy and execution of assigned drug development programmes from pre-clinical to clinical development. You will lead a cross-functional team to ensure alignment of scientific, regulatory, translational, safety and commercial aims.

The role requires strong collaboration with stakeholders, driving decisions at governance milestones and guiding the programme from IND/CTA through proof-of-concept.

Qualifications

• PhD, MD or equivalent advanced scientific/medical training.
• 10+ years in pharmaceutical/biotech R&D with cross-functional programme leadership.
• Experience progressing programmes from pre-clinical to clinical development.
• Experience with IND/CTA submissions and global regulatory interactions.
• Experience in biologics development including antibodies or multispecifics.
• Strong strategic thinking, execution and risk-management.

Responsibilities

• Own integrated global strategy and value creation plan for assigned programmes.
• Lead cross-functional Global Project Team with clear objectives and governance.
• Define Target Product Profile and development objectives linked to patient needs.
• Integrate scientific, translational, regulatory, safety and commercial perspectives.
• Drive risk management, governance milestones and decision-quality evidence.
• Communicate programme strategies to senior stakeholders and external partners.

Skills

Program leadership

Cross-functional collaboration

Strategic planning

Stakeholder management

Regulatory strategy

Risk management

Biologics development

Education

PhD, MD or equivalent

Job description

Ailux is seeking a Global Project Leader to own the integrated strategy and execution of assigned drug development programmes from pre-clinical to clinical development. You will lead a cross-functional team to ensure alignment of scientific, regulatory, translational, safety and commercial aims.

The role requires strong collaboration with stakeholders, driving decisions at governance milestones and guiding the programme from IND/CTA through proof-of-concept.