Ailux is an innovative biotechnology company harnessing AI to accelerate breakthrough biologic therapies in difficult immune-mediated diseases and improve the lives of patients with significant unmet medical need. Built on intelligent design and guided by people who care about transforming healthcare, our technology is redefining what is possible in biologics development, from how we select targets to how we engineer the molecules.Ailux’s vision is to light the path to new cures and fundamentally change our approach to science and drug development to redefine current treatment paradigms. We look to continue unlocking the potential of disease biology, integrate AI-enabled biologics development, and deliver effective clinical execution.Backed by an experienced leadership team, leading scientific advisors, a highly multidisciplinary organization, and strategic partnerships in biopharma, Ailux is approaching a key inflection point as its first wave of therapeutic programs advance toward clinical development. This is an opportunity to play a vital role in leading programs from pre-clinical development into the clinic and through clinical proof-of-concept, shaping the pipeline and development culture of a rapidly growing biotechnology company. Role Overview The Global Project Leader (GPL) is accountable for the integrated strategy, leadership and delivery of assigned drug development programmes from pre-clinical development through clinical development. Working through a cross-functional Global Project Team, the GPL provides the single point of leadership for the programme, ensuring that scientific, clinical, regulatory, CMC, safety, translational and commercial considerations are integrated into a coherent development strategy and executable project plan. The GPL is accountable for defining the programme vision, Target Product Profile and value proposition; establishing clear development objectives and decision criteria; identifying and managing critical risks; and driving timely, evidence-based decisions at key investment and governance milestones. The role spans IND/CTA/FDA/China-enabling development, first-in-human studies, early clinical development and proof-of-concept, with scope to continue into later-stage clinical development as programmes mature. The GPL leads by influence across functions and geographies rather than through line authority. They will create a high-performing project team with clear accountabilities, transparent decision-making and strong execution discipline. The GPL will work closely with Research, Pre-clinical Development, Clinical Development, Translational Medicine, Regulatory, CMC, Safety, DMPK/Clinical Pharmacology, Biometrics, Project Management, Finance and Business Development, and will represent the programme at senior governance forums and with external partners as required. Key Accountabilities establish mitigation and contingency plans and escape material issues appropriately. Monitor programme performance against objectives, timelines and budget and drive corrective action when required. Balance pace and ambition with appropriate scientific rigour, patient safety, quality and regulatory compliance. Communication direct experience with first-in-human and early clinical programmes is strongly preferred. Broad understanding of the drug development process, including non-clinical development, clinical development, translational medicine, regulatory strategy, CMC, safety, DMPK/clinical pharmacology and biometrics. Experience leading multidisciplinary project teams and driving decisions without direct line authority. Proven ability to develop integrated programme strategies, identify critical value drivers and translate complex data into clear development choices and investment recommendations. Experience with stage-gate governance, portfolio decision-making and preparation of high-quality materials for senior decision forums. Strong strategic thinking combined with excellent execution, prioritisation, problem-solving and risk-management skills. Excellent communication, influencing and stakeholder-management skills, with credibility across scientific, clinical, operational and business audiences. Ability to operate effectively in a fast-moving, entrepreneurial environment with evolving processes, priorities and organisational structures. Commitment to patient safety, scientific integrity, quality and ethical drug development. Experience in respiratory and/or immunological diseases and relevant therapeutic modalities. Experience taking a programme through clinical proof of concept and into later-stage development. Experience supporting IND/CTA submissions and interactions with major global regulatory authorities. Experience in biologics development, including antibodies, multispecifics or other next-generation therapeutic modalities. Experience in global development teams spanning multiple geographies, including China, Europe and/or the United States. Experience with external partnerships, licensing, due diligence or alliance management. Experience operating successfully in a growing biotechnology company. Leadership Profile The successful candidate will combine scientific depth, strategic judgement and delivery excellence. They will move confidently between detailed programme data and portfolio considerations, identify the critical questions for value creation and build alignment around clear decisions. Collaborative but decisive, they will be comfortable with uncertainty and skilled at leading senior cross-functional experts without relying on hierarchy. Above all, the Global Project Leader will take end-to-end ownership, connecting pre-clinical and clinical development into a coherent strategy that enables fast, rigorous decisions and delivery of differentiated medicines to patients.
VP,Global Project Leader employer: AiLux S.r.l.
Ailux is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the vibrant field of drug safety for biologics and peptides. With a strong emphasis on employee growth and development, Ailux offers unique opportunities to lead cutting-edge projects while contributing to meaningful advancements in respiratory and immunology therapies. Located in a dynamic environment, employees benefit from a supportive atmosphere that encourages creativity and professional advancement.