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 & Responsibilities
Programme Strategy & Leadership
- Own the integrated global strategy and overall value creation plan for assigned programmes from pre-clinical development through clinical development.
- Lead the cross-functional Global Project Team, establishing a compelling programme vision, clear objectives, accountabilities, ways of working and decision-making processes.
- Develop and maintain the Target Product Profile and ensure the development strategy is anchored in patient need, differentiated product potential, competitive landscape and a clear path to proof of concept and registration.
- Integrate scientific, translational, clinical, regulatory, safety, CMC, operational and commercial perspectives into a single coherent programme strategy.
- Ensure programme assumptions, key uncertainties and success criteria are explicit, testable and linked to stage-appropriate investment decisions.
- Drive high-quality, timely decisions and recommendations for portfolio and governance bodies, including progression, acceleration, re-prioritisation or termination where appropriate.
Pre-clinical Development & Transition to Clinic
- Lead integrated IND/CTA/FDA/China-enabling development plans, ensuring alignment across pharmacology, DMPK, toxicology/safety, bioanalysis, CMC, translational medicine and regulatory strategy.
- Ensure pre-clinical packages are designed to address the critical scientific and regulatory questions required for first-in-human entry while balancing speed, quality, cost and risk.
- Ensure robust translation of pre-clinical pharmacology and exposure-response relationships into human dose, schedule, biomarker and clinical study hypotheses.
- Drive candidate-to-clinic planning, including development candidate readiness, non-clinical safety strategy, clinical supply readiness, regulatory documentation and operational preparedness.
- Lead programme responses to emerging pre-clinical findings and ensure risks are appropriately characterised, mitigated and communicated.
Clinical Development & Proof of Concept
- Partner closely with the Clinical Lead/Clinical Development function to define the clinical development strategy, including first-in-human, dose escalation, dose optimisation, expansion and proof-of-concept studies.
- Ensure clinical plans test the key programme hypotheses and generate decision-quality evidence on safety, pharmacology, target engagement, biological activity, patient selection and clinical benefit.
- Integrate clinical, translational, biomarker, pharmacokinetic/pharmacodynamic and safety data to guide dose selection, indication strategy and programme progression.
- Drive rapid interpretation of emerging clinical data and ensure development plans adapt appropriately to new evidence, competitive developments and regulatory feedback.
- Ensure the programme maintains a credible path from early clinical development to later-stage development and registration, including consideration of endpoint strategy, patient populations, comparators and evidence requirements.
Integrated Project Planning, Delivery & Risk Management
- Own the integrated programme plan, key milestones, critical path, dependencies, decision points, resource requirements and budget in partnership with Project Management and functional leaders.
- Ensure functional plans are aligned with programme priorities and that cross-functional dependencies are actively managed.
- Identify scientific, clinical, regulatory, technical, operational and commercial risks early; 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 & Stakeholder Management
- Prepare and present clear, evidence-based programme strategies, investment proposals and recommendations to senior stakeholders and portfolio decision-making bodies.
- Act as the principal cross-functional spokesperson for the programme internally, ensuring stakeholders understand programme strategy, status, risks, decisions and next steps.
- Build effective relationships with senior leaders and functional experts across Ailux and resolve cross-functional issues constructively.
- Represent the programme with external collaborators, development partners, consultants and scientific experts as required.
- Support partnering, due diligence and business development activities by providing an integrated view of programme strategy, differentiation, risks and value.
Team & Organisational Leadership
- Create an inclusive, high-performing Global Project Team culture characterised by scientific challenge, constructive debate, accountability, speed and transparency.
- Lead through influence and ensure functional expertise is fully leveraged while maintaining clear programme-level accountability.
- Coach and develop project team members in integrated drug development thinking and decision-making.
- Contribute to the evolution of Ailux project leadership, governance and drug development capabilities as the organisation expands its clinical-stage portfolio.
- Promote a patient-focused, data-driven and learning-oriented culture across programme teams.
Quality, Compliance & Patient Safety
- Ensure programme activities are conducted in accordance with applicable GxP requirements, ethical standards, regulatory expectations, patient-safety principles and company policies.
- Ensure appropriate quality and compliance considerations are embedded in programme strategy and execution from pre-clinical development through clinical studies.
- Partner with relevant functions to ensure significant safety, quality or compliance issues are rapidly assessed, escalated and addressed.
Experience & Skills
- PhD, MD or equivalent advanced scientific/medical training in a relevant discipline.
- Typically 10+ years’ experience in pharmaceutical or biotechnology R&D, including substantial experience in drug development and cross-functional programme leadership.
- Demonstrated experience progressing therapeutic programmes through pre-clinical development and into clinical development; 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.
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