The Head of Translational Medicine & Biomarker Discovery

The Head of Translational Medicine &

Biomarker Discovery (TMBD) is a senior scientific leadership role

responsible for translating biological insights into clinical development

strategies and patient-focused outcomes across the Ailux pipeline. The role

provides strategic and scientific leadership across translational medicine,

biomarker discovery and development, human target validation, target

engagement, mechanism of action (MoA), and precision medicine and reports in to

the Head of Translational Research. The Head of TMBD will ensure that robust,

integrated translational strategies are established and executed across

portfolio programmes, enabling high-quality decisions throughout the drug

development lifecycle and increasing the probability of clinical and regulatory

success.

A

key focus of the role is to establish and deliver fit-for-purpose biomarker

strategies, from discovery through clinical deployment. This includes

identifying and validating biomarkers that demonstrate target engagement,

elucidate MoA, support patient selection and stratification, monitor

pharmacodynamic effects, and inform clinical decision-making. The Head of TMBD

will also lead the Biomarker Discovery

and Assay team, driving the application of innovative and contemporary

molecular technologies to identify, develop and operationalise clinically

relevant biomarkers. The role will foster a culture of scientific excellence,

innovation and collaboration, ensuring that emerging technologies are

effectively translated into meaningful drug development applications. The role

has accountability for the legally

compliant, ethical and efficient management and use of human biological samples

(HBS) across translational activities. This includes establishing

appropriate sampling strategies within clinical development plans, ensuring

operational feasibility for biomarker interrogation, maintaining robust

governance and SOPs, and acting as the organisational focal point for

HBS-related activities. As a member of the transitional leadership team, the

Head of TMBD will contribute to the development and implementation of Ailux's

broader translational strategy and provide expert scientific leadership across

multidisciplinary project teams.

Key Accountabilities & Responsibilities

Translational Medicine & Biomarker Strategy

• Develop and deliver integrated translational

science strategies across all portfolio programmes, from early discovery

through clinical development.

• Establish translational plans encompassing human target validation, target engagement,

biomarker discovery and validation, MoA, patient selection and precision

medicine.

• Develop and implement biomarker strategies

for clinical-stage programmes to support clinical decision-making, risk

mitigation, dose selection, patient stratification and regulatory success.

• Ensure biomarker strategies are aligned with

programme objectives and embedded appropriately within clinical development

plans.

• Identify opportunities to use translational

data to strengthen understanding of disease biology, target biology and

therapeutic response.

• Provide expert scientific input into

programme strategy, study design, clinical sampling strategies and

interpretation of translational and clinical data.

• Ensure that biomarker approaches are

scientifically robust, operationally feasible and appropriately positioned for

clinical development.

Biomarker Discovery & Assay Development

• Provide strategic and scientific

leadership to the Biomarker Discovery and Assay team.

• Lead the identification, development,

validation and implementation of target engagement, pharmacodynamic and other

decision-enabling biomarker assays.

• Drive the application of emerging molecular

technologies and methodologies to accelerate biomarker discovery and

translational science.

• Ensure assays are appropriately validated,

fit for purpose and successfully deployed within clinical studies.

• Promote innovative approaches to biomarker

discovery and the generation of clinically meaningful translational insights.

• Ensure appropriate integration of

laboratory-based biomarker data with pharmacology, clinical and other

translational datasets.

Scientific & Organisational Leadership

• Contribute to the development and execution

of the Ailux translational medicine strategy and provide scientific leadership

across multidisciplinary project teams.

• Serve as a recognised subject-matter expert

and provide strategic guidance to colleagues across Research, Development and

other relevant functions.

• Apply deep specialist expertise while

maintaining a pragmatic, hands-on approach to solving complex scientific and

drug development challenges.

• Build strong internal and external networks

and establish productive collaborations with academic institutions,

biotechnology companies, pharmaceutical partners and other external experts.

• Create an environment that encourages

scientific challenge, innovation, collaboration and high performance.

• Lead, motivate and develop direct reports,

including performance management, career development and succession planning.

• Build organisational capability in

translational medicine and biomarker science in line with the evolving needs of

the Ailux pipeline.

Human Biological Samples & Governance

• Own the governance and operational framework

for the compliant, ethical and efficient use of human biological samples (HBS)

for translational research and development activities.

• Act as the focal point within Ailux for

HBS-related activities, providing guidance and oversight across programmes.

• Ensure appropriate HBS sampling strategies

are incorporated into clinical development plans, balancing scientific

requirements with patient, clinical and operational considerations.

• Ensure translational scientists and relevant

study teams receive appropriate training and education on HBS requirements,

policies and procedures.

• Develop, implement and maintain HBS SOPs and

associated governance processes, ensuring continued compliance and operational

effectiveness.

• Enable the appropriate collection,

processing, storage and use of HBS for biobanking and project-specific

translational activities.

• Ensure all activities comply with applicable

ethical, legal, regulatory and company requirements.

Quality, Compliance & Risk Management

• Ensure that activities within the function

are conducted in accordance with applicable Good Laboratory Practice (GLP),

Good Clinical Practice (GCP), Health, Safety & Environment (HSE)

requirements and relevant internal policies and external regulations.

• Maintain awareness of evolving scientific,

technical and regulatory developments and ensure these are appropriately

reflected in translational and biomarker strategies.

• Proactively identify and mitigate scientific,

operational and regulatory risks associated with translational medicine and

biomarker activities.

Experience & Skills

Essential

• PhD or equivalent

experience in a relevant scientific discipline.

• 10+ years'

experience in pharmaceutical R&D, with significant experience in drug

development and translational science.

• Extensive

experience across translational medicine, biomarkers, biology, pharmacology

and/or clinical sciences, with recognised expertise in at least one of these

disciplines.

• Deep understanding

of drug discovery and development, including the progression of programmes from

early research through clinical development and, ideally, commercialisation.

• Strong expertise in

immunology and/or respiratory disease, including disease biology, therapeutic

mechanisms and clinical development approaches.

• Demonstrated

experience developing and implementing translational and biomarker strategies

across drug development programmes.

• Strong

understanding of technologies and their application to target identification

and validation, biomarker discovery, target engagement and clinical biomarker

deployment.

• Experience leading

laboratory-based assay development and translating biomarker methodologies into

clinical studies.

• Proven ability to

interpret complex scientific data and translate it into clear, actionable

recommendations for programme decision-making.

• Demonstrated people leadership experience,

including the ability to attract, develop, motivate and empower high-performing

scientific teams.

• Experience

establishing and managing external collaborations with academic, biotechnology

and/or pharmaceutical partners.

• Strong

understanding of relevant scientific,

technical, ethical and regulatory requirements, including those

governing human biological samples.

• Excellent

communication, influencing and stakeholder-management skills, with the

credibility to engage effectively with senior scientific, clinical and business

leaders.

• Strong strategic

thinking combined with a pragmatic, delivery-focused approach.

Desirable

• Experience in precision medicine, patient

stratification or companion diagnostic strategies.

• Experience taking biomarkers from discovery

through analytical validation and clinical implementation.

• Experience with innovative molecular

profiling technologies, including multi-omics or other emerging biomarker

platforms.

• Experience supporting regulatory interactions

or submissions involving translational or biomarker strategies.

• Experience operating successfully in a

growing or entrepreneurial biotechnology environment.

Leadership Profile

The

successful candidate will combine scientific depth with strategic leadership

and delivery excellence. They will be a credible and collaborative scientific

leader who can move confidently between detailed scientific discussions and

high-level portfolio decisions. They will be intellectually curious, externally

connected and comfortable challenging established thinking. They will bring a

strong understanding of how translational science can de-risk drug development,

accelerate decision-making and ultimately improve the likelihood of delivering

effective medicines to the patients who need them. Above all, the Head of TMBD

will be a scientific leader who can connect discovery, translational research

and clinical development, building the capabilities, partnerships and

strategies required to maximise the value of the Ailux pipeline.