Eugenie Martineau, PhD

Independent practice serving pharma and biotech clients across Europe and internationally. Positioned at the interface between science, regulatory and medical communications. Services include: - Scientific writing: manuscripts, peer-reviewed publications, literature reviews, abstracts and posters. - Medical communications: educational content, promotional materials, MSL training tools, advocacy plans, advisory boards, slide decks, quality control. - Clinical & regulatory document support: protocol, IB, ICF and CSR review and quality control; DSUR and PV documentation; RFI responses; submission coordination. - Medical translation (EN/FR): publications, clinical documentation, educational and promotional materials. - Clinical strategy & operations support: Phase I-II program coordination, scientific positioning, regulatory strategy support, KOL mapping and advisory board design. Fully remote, across Europe and internationally.

Co-led a portfolio of 7 Phase I-II programs (immuno-oncology & immuno-inflammation), including 1 sponsored trial with CRO oversight and 6 ISS, across 4 countries, 50+ sites and a multi-stakeholder ecosystem of internal teams, CRO, vendors, advisors and academic institutions. All programs operated under CTR/CTIS framework. • Co-built the company's full clinical operations and pharmacovigilance infrastructure from scratch (SOPs, vendor governance, PV framework and quality systems), on time and within budget. • Reviewed study-level scientific and regulatory documentation across the portfolio: protocols and amendments, IB, ICF, CSR, coordinating input from medical, regulatory and PV stakeholders. • Coordinated PV operations : SAE reconciliation, line listings review, signal detection, DSUR preparation and PV vendor oversight. • Managed regulatory submissions and RFI responses across all programs, ensuring alignment with EMA, national authority requirements and CTR/CTIS timelines. • Negotiated program-specific frameworks with each ISS institution and PI (PV, GDPR, regulatory submissions, data standards) without formal sponsor authority. • Monitored recruitment dynamics and protocol compliance; coordinated corrective actions and deviation management with PIs. • Managed IMP supply strategy, forecasting and logistics to ensure continuity of clinical trial supplies.

Contributed to the evaluation of early-stage healthcare innovations, including therapeutics, diagnostics, medical devices and digital health technologies, supporting translational and commercialisation decision-making. • Analysed disclosed innovations and prepared structured decision-support documents assessing clinical relevance, market potential and development feasibility • Assessed scientific and technological opportunities as part of innovation selection and portfolio evaluation processes • Presented analytical findings supporting technology transfer and commercialisation discussions • Co-inventor of a technology selected for final innovation assessment and decision-support review

Conducted data-driven microbiome research supporting translational therapeutic development through large-scale genomic and metagenomic analysis. • Analysed complex biological datasets to identify patterns and generate evidence supporting research and clinical decision-making. • Collaborated with bioinformatics, clinical and multidisciplinary teams to design analytical approaches and interpret genomic data. • Co-authored a book chapter on early-life microbiome (Elsevier, 2021) and presented research at EMBO conference (2019). • Recipient of the Mount Sinai Innovation Idea Award (2019).

Joint doctoral program - Aix-Marseille University / Princeton University, Lewis-Sigler Institute. Quantitative analysis of large-scale biological imaging datasets to investigate complex multicellular systems and protein dynamics. • Developed semi-automated analytical workflows using computational tools (ImageJ/Fiji, MATLAB, R) to extract and model high-dimensional biological data. • Built quantitative models and visual analyses supporting hypothesis testing and data-driven experimental decision-making. • Published 3 peer-reviewed articles including co-first authorship in Nature Microbiology (2018) ; presented research at 6 international conferences. • Defended doctoral thesis with highest honors.

Joint doctoral program with Aix-Marseille University Conducted quantitative analysis of large-scale biological imaging datasets to investigate complex multicellular systems and protein dynamics. • Developed semi-automated analytical workflows using computational tools (ImageJ/Fiji, MATLAB, R) to extract and model high-dimensional biological data • Built quantitative models and visual analyses supporting hypothesis testing and data-driven experimental decision-making • Synthesised complex analytical findings and presented results at international scientific conferences and in peer-reviewed publications

Contributed to translational research projects focused on anti-tuberculosis therapeutic development in collaboration with Roche Pharmaceuticals. • Participated in the evaluation and screening of small-molecule compounds supporting early-stage drug discovery initiatives • Developed innovative biological systems enabling functional expression of complex membrane proteins for therapeutic research applications • Co-authored a peer-reviewed publication in Proceedings of the National Academy of Sciences (PNAS)