Client confidentiality is a core principle of my professional practice. The examples presented here are anonymised representations of work performed across the biotechnology and pharmaceutical sectors and are intended solely to demonstrate relevant expertise, approaches, and problem-solving capabilities.
Company
Confidential oncology biotech
Description
Led an integrated translational biomarker strategy for a first-in-human Phase 1/2 haemato-oncology study. Connected preclinical pharmacology, clinical sampling, assay implementation, immune monitoring, and EDC data capture.
Problem
The client was preparing to enter a first-in-human Phase 1/2 haematology-oncology study and needed to translate preclinical findings into clinically actionable evidence of target engagement, biological activity, and potential response or resistance.
Action
Led the translational biomarker strategy by reviewing preclinical data, defining pharmacodynamic timing and clinical sampling, designing clinically deployable assay strategies, developing a high-parameter immune-monitoring flow cytometry panel, authoring GxP SOPs, and integrating biomarkers into the clinical protocol, Schedule of Assessments, and EDC system.
Result
Delivered an integrated translational strategy package, biomarker protocol and Schedule of Assessments, two clinical biomarker methods developed and transferred for external implementation, a laboratory manual, an immune-monitoring flow cytometry panel, and EDC data capture with UAT completed before study initiation. The resulting framework linked preclinical findings, clinical sampling, biomarker analysis, and data capture into a single translational evidence-generation strategy supporting first-in-human study readiness.
Key capabilities:
Translational biomarker strategy • First-in-human studies • Pharmacodynamic biomarkers • Flow cytometry • Clinical immunomonitoring • Clinical assay implementation • GxP • Clinical protocol development • EDC
Company
Confidential oncology biotech
Description
Enabled trial readiness for a first-in-human oncology programme through laboratory implementation planning, CRO selection, sample-management processes, and GCP-compliant governance.
Problem
A biotechnology company preparing for a first-in-human oncology study required laboratory implementation planning and operational readiness for biomarker sample collection and analysis. Requirements for sample collection, processing, storage, shipment logistics, analytical workflows, and governance needed to be translated into a cohesive laboratory framework to support compliant study execution.
Action
Performed a gap analysis and mapped biomarker samples and assays to study objectives, translating scientific requirements into an implementation-ready laboratory package covering sample collection, processing, storage, logistics, and analysis. Established a GCP-compliant CRO selection process, including RFI/RFP workflows, evaluation criteria, vendor assessment, technical audit guidance, and laboratory-specific GCP training.
Result
Enabled the central laboratory to implement sample collection and analysis as planned, supporting successful study start-up, patient dosing, and active trial enrolment. The resulting documentation, operational framework, and governance processes supported study execution and ongoing translational sample-management activities.
Key Capabilities: Clinical trial readiness • Biomarker operations • Laboratory implementation • Sample management • Central laboratory oversight • CRO selection • Vendor governance • RFI/RFP development • Technical audits • GCP • Translational research • Oncology clinical development
Company
Prokarium | Director of Translational Research | 2021–2024
Description
Led the design and execution of a translational feasibility study establishing operationally viable urine collection, storage, and shipment procedures for centralized immunomonitoring in bladder cancer clinical studies.
Problem
Centralized immunomonitoring can improve standardization and analytical consistency in multicentre bladder cancer trials, but evidence supporting standardized centralized immunomonitoring and scalable implementation of biomarker programmes in multicentre studies. The challenge was to determine whether clinically relevant cellular and protein biomarkers remained suitable for downstream analysis following realistic storage and shipment conditions.
Action
As Director of Translational Research, I conceived and led a prospective feasibility study designed to address a key operational barrier to centralized immunomonitoring in multicentre bladder cancer trials. Working with an internal translational research team and clinical collaborators at Lausanne University Hospital, I designed the study strategy, defined the analytical framework, and oversaw execution. We evaluated refrigerated urine storage using both healthy-donor leukocyte spiking experiments and samples from BCG-treated NMIBC patients, assessing immune-cell phenotypes and soluble biomarkers by multiparameter flow cytometry and Luminex. I subsequently translated the findings into practical recommendations for urine collection, storage, shipment, and processing that could be incorporated into laboratory manuals and clinical-trial protocols.
Result
Demonstrated stability of urinary leukocytes and proteins, including 46 immune-related mediators, under clinically relevant refrigerated-storage conditions. The resulting sample-handling recommendations were incorporated into laboratory manuals and clinical-trial protocols, supporting standardized centralized immunomonitoring and more scalable biomarker operations for multicentre studies.
Key Capabilities:
Clinical immunomonitoring • Translational biomarkers • Biomarker implementation • Flow cytometry • Luminex • Sample logistics • Clinical operations • Bladder cancer • Biomarker strategy • Translational research • Protocol development • Multicentre clinical studies
Company
Prokarium | Director of Translational Research | 2021–2024
Description
Designed and implemented infrastructure linking biospecimen management, CRO workflows, and biomarker reporting, enabling end-to-end traceability across translational programmes.
Problem
Translational programmes lacked a unified system connecting biospecimens, analytical workflows, and patient-level biomarker data. Paper-based sample receipt and laboratory reporting, combined with distributed records across organisations, limited traceability and oversight required for clinical development and biomarker operations.
Action
Designed and implemented a digital sample and data-management framework centred on data integrity and interoperability. Worked with internal teams and CROs to define shared data standards, metadata requirements, and verification rules. Enabled direct CRO registration of sample receipt, automated metadata capture, and generation of patient-specific PK-series records without manual entry. Established traceable links between biospecimens, analytical workflows, EDC data, and reporting outputs.
Result
Established a compliant, end-to-end framework for translational sample and biomarker data management supporting a first-in-human clinical programme. Enabled direct CRO documentation of sample receipt and analytical activities, automated capture of sample metadata, reliable reconciliation with EDC records, and patient-level biomarker reporting. The resulting infrastructure provided full traceability from sample collection through analysis and reporting, eliminating reliance on paper-based workflows and improving operational oversight across translational activities.
Key Capabilities:
Translational operations • Biospecimen management • Sample traceability • LIMS • Clinical data management • EDC reconciliation • CRO management • Biomarker operations • Data integrity • Clinical development • Translational research infrastructure • Process design
Company
Adaptimmune | Principal Scientist / Deputy Project Leader| 2020-01 – 2021-12
Description
Coordinated cross-functional scientific, translational, preclinical, and CMC activities supporting programme integration, development reporting, and knowledge transfer in a PRAME TCR collaboration.
Problem
Over approximately one year, the PRAME TCR collaboration needed to consolidate independently generated datasets, reports, and technical documentation from multiple functions, including Discovery, Translational Research, Preclinical Development, and CMC, into a coherent and traceable evidence package for programme handover. Programme knowledge was distributed across two organizations, with differing reporting formats, assumptions, levels of detail, and institutional context. The challenge was to preserve scientific rigor and decision-making rationale while ensuring continuity and accessibility of information across teams.
Action
As Deputy Project Lead, coordinated 10+ scientific and technical contributors, project and scientific leads, and SVP- and VP-level stakeholders across both organizations. Established a common reporting framework, harmonized data presentation across functions, identified information gaps and missing context, and integrated individual findings into a coherent, decision-ready development package. Ensured scientific rationale, key decisions, and supporting evidence remained traceable and accessible to stakeholders with different technical backgrounds and levels of programme familiarity.
Result
Over approximately one year, helped consolidate multiple reports, datasets, and supporting technical documents into a unified development package spanning 4+ major functions. Established a coherent, traceable framework that preserved scientific rationale, programme knowledge, and decision-making context, positioning the programme for handover and supporting continuity between partner organizations.
Key Capabilities:
Programme leadership • Cross-functional leadership • Matrix team management • Cell therapy • TCR-T therapies • Translational research • Preclinical development • CMC coordination • Scientific reporting • Knowledge management • Stakeholder management • Strategic partnerships • Drug development
Company
German Cancer Research Center | Postdoctoral Scientist | 2008-03 – 2012-06
Description
Led translational immunology research investigating immune suppression, chronic inflammation, and biomarker development in melanoma, bridging preclinical findings with clinical immunomonitoring and immunotherapy studies.
Problem
Melanoma creates a chronically inflamed yet immunosuppressive tumour microenvironment, requiring treatment strategies that rebalance suppressive and anti-tumour immune populations rather than relying solely on direct tumour-cell killing. A central challenge was to understand how therapeutic interventions reshape the immune landscape, distinguish tumour-specific effects from systemic immune responses, and identify biomarkers that could be translated from preclinical models into clinical immunomonitoring.
Action
Led a translational immunology programme investigating mechanisms of immune suppression and therapeutic immune modulation in melanoma. Designed multiparameter flow-cytometry panels to characterise the phenotype and functional activity of MDSCs, regulatory T cells, and effector immune populations, and applied these across mouse models, human blood, and tumour samples. Integrated immune-cell profiling, inflammatory mediators, and proteomic analyses to identify biomarkers associated with therapeutic response, mechanism of action, and prognosis. Translated preclinical findings into clinical immunomonitoring strategies, informing biomarker development and clinical immunomonitoring approaches for melanoma patients receiving immunomodulatory therapies including ipilimumab and tadalafil.
Result
Generated a translational framework linking tumour immunology, immune monitoring, and clinical biomarker development. Identified immune signatures associated with treatment activity and clinical outcome, including MDSCs, eosinophils, inflammatory mediators, and T-cell activation markers. The work informed clinical immunomonitoring approaches in melanoma, supported biomarker-driven evaluation of immunotherapies including ipilimumab and tadalafil, and resulted in multiple peer-reviewed publications spanning preclinical and clinical cancer immunology.
Key Capabilities:
Translational immunology • Biomarker discovery • Clinical immunomonitoring • Flow cytometry • Immune profiling • Proteomics • Immuno-oncology • Melanoma • Checkpoint inhibitors • Biomarker development • Translational biomarkers • Preclinical-to-clinical translation
Selecting the right biomarkers to support clinical decision-making, patient stratification and proof-of-mechanism.
Connecting biological insights with clinical development objectives.
Helping teams design smarter early-phase studies and reduce development risk.
Building systems that connect biospecimens, laboratory workflows, biomarker data, and clinical programmes.
Aligning sample workflows, analytical capabilities, and biomarker objectives to support reliable clinical decision-making.
Building governance frameworks that support compliant, reliable, and decision-ready data generation.