Strategically assessing the scientific, technical, and commercial viability of biotech projects

Grant writing and review (especially impact section, general outline and structure of the proposal)

Coaching, training and workshops for researchers and teams especially about value proposition and product-market fit

Project and strategic partnership management

Regulatory Strategy

Regulatory CMC

Cross functional management 

Geographical expansion

Expertise in diagnostics (IVD, assays), biomarker development (auto-antibodies, protein production), and healthcare innovation

Strategic leadership to align scientific innovation with market and customer needs

A collaborative mindset that builds strong relationships with stakeholders to scale solutions globally

A passion for fostering team growth, promoting mental well-being, and empowering individuals to thrive within organisations

Scientific 2D illustrations and graphics that make complex topics accessible

Visual expertise in anatomy, surgery, and cellular biology, including drug mechanisms of action

Clear, engaging images tailored to both specialists and broader audiences

Strategic input on how to communicate science effectively through illustration

Software Regulatory & Quality Compliance Support

Bioinformatics & Clinical Software Development

Strategic Business & Operational Support

Risk Management & Process Optimisation

Therapeutic antibody strategies, discovery, lead optimisation & engineering

Pre-clinical development, assay design & in vivo models

R&D management, guidance of in-house & outsourced projects

Scientific & technical writing, data overviews, development plans, or (pre-)IND dossiers

In Vivo and Pre-clinical Platforms, Technology and Tools - Strategy and Sourcing 

Genome engineering - In-house adoption and Outsourcing

Cross-functional team leadership, mentorship and integration

Complex stakeholder and partnership management

Medical and Scientific Writing

Medical communications 

Editing, proofreading, and fact-checking of medical, scientific, academic, and regulatory documents

Translation of documents from/to English, Italian

Scientific strategy and project leadership across Early discovery, preclinical and IND-enabling projects

Expertise in immunology and immunotherapy

Building/coaching teams and developing company culture

Training and mentorship for young scientists

Supporting clients’ early drug development activities for Biologics drug modalities. Enabling early CMC activities including CDMO selection.

Expertise includes  drug lead candidates selection activities, mammalian cell line expression platforms, transient expression, cell line development for production of the candidate molecules and target proteins.

Supporting early drug development for other modalities likes RNA/DNA drug/vaccine development and AAV (viral vector) production,

Interim leadership, talent acquisition support and any other requirements that aligns with my experience

Market analysis and competitive landscaping

Innovation strategy

Discovery services, such as technology landscape analysis, partner/vendor selection, scientific consulting

Operational and technical support, and slide-deck generation for start-ups

CMC process development: end-to-end support in process development, scale-up and tech transfer to accelerate biotech CMC development and commercialization

Strategic support for GMP manufacturing for biologics

Strategic implementation of process optimization, tech transfer, and GMP compliance for early and late-stage biologics

Scientific strategy and project management

Gap analysis for regulatory strategy

Biweekly mentoring to navigate regulatory challenges

Development of a structured roadmap to advance toward the clinic

Hands-on support to accelerate First in Human success

Leading end-to-end talent strategy for Biotech start-ups

Partnering closely with C-suite leadership to shape organizational design

Scaling Biotech teams without compromising the candidate journey

Experienced in Technical and Operational/ HQ Function skill sets

Provide tailored, end-to-end CMC technical development solutions to improve and accelerate the drug development journey

Support Biologics CDMO selection process

Oversee and manage tech transfer and cGMP manufacturing operations

Navigate the complexities of the CMC regulatory landscape

Discovery, Preclinical and IND-enabling projects

Cell Therapy Platform & Process Development 

Technical Expertise & Troubleshooting 

Overseeing project teams, ensuring smooth program execution and milestone achievement

Commercial support for start up/small companies in the tech bio space. 

Sales Leadership

Business Development

Market development

Leading and managing end-to-end Phase I-IV clinical trials for biotech and pharma companies.

Providing clinical strategy and operational efficiency consulting to streamline trial execution.

Building and developing high-performing clinical operations teams, including talent development and CRO oversight.

Advising on clinical development strategies across multiple therapeutic areas, including neurosciences and gene therapy.

Organisation Development

Restructuring

Start-up

RemCom support

Science writing and editing: research articles, reviews, web content, press releases, translations (English/French/Spanish)

Other communication pieces: posters, slide decks, patient information

Audience engagement: social media posts, newsletters, infographics

Live: graphic facilitation, graphic recording

Supporting Start up biotechs in organisation development, R&D Operations

Clinical Operations Leadership and development, CRO Selection and Oversight

Project Management development including Board presentations

Clinical Operations review for Venture Capital Investment

Early stage drug discovery from target ID to preclinical

Advising and assisting biotech startups

Application of platform technologies

Data analysis and management

Scientific strategy and project management in life science

Consulting on innovative approaches and ideas in biomedical sciences and TechMed

Grant writing and funding support

Start-up pitch and value proposition preparation

Regulatory & technical consultancy for medical devices under EU MDR

Clinical data analysis & visualization

Scientific writing & communication

Technical expertise in digital medical devices & biomarkers, neuroengineering, brain-computer interfaces, neuromechanical signals (EEG, EMG).

Medical and scientific writing

Editing and proofreading

Document translation (English/Italian)

Development of educational content

Visuals that bridge the gap between science and society.

Support for academics, biotech, and pharma through visuals that stand out, while maintaining scientific accuracy and relevance.

2D Illustrations, graphic abstracts, annual reports, information design, and visual communication strategy.

Medical and scientific illustration, from the anatomical to the molecular level.

Conducting scientific literature and regulatory information reviews and creating reports

Developing quality management audit and operations documents

Preparing and reviewing medical affairs slide decks and scientific PowerPoint presentations

Creating engaging white papers and educational content

Financial strategy from inception to Series A

Market access and opportunity assessment

CDMO/CRO sourcing and qualification (biologics)

Fundraising: pitch, structure, and roadmap

CDMO or CRO vendor search, identification, negotiation, and qualification for Biotech/Pharma

Lead generation, negotiation and qualification for CROs/CDMOs

Regulatory consulting: MDR in Europe and NMPA in China

Investment pitch preparation and investor outreach

Process development: scale up and tech transfer of biologics for early and late stage manufacturing

Process characterisation, validation for commercial manufacture and pre-requisites for BLA filing

Use of microbial strains used for both early and late stage GMP manufacturing, strain characterisation (RCB, MCB, WCB) 

Experience of selecting and managing contract research organisations for outsourced work 

Lead early-stage clinical development initiatives.

Close collaboration with founders and leadership to align scientific goals with business growth strategies, ensuring alignment with investor and regulatory expectations.

Development of end-to-end clinical development strategy (CDP, TPP, ect.)

Designing and reviewing patient-centric clinical studies

Data stewardship and data management, specializing in R&D chemistry and small molecules data management.

Build efficient data strategies to unlock value for company and department, including change management.

Uncover and engage with all the teams involved to optimize data utilization and problem-solving in data management. 

Propose processes for data analysis and reporting to enhance decision-making

Assay and Product Development for research tools and diagnostics

Product Development Process design and implementation (ISO 13485, ISO 9001) including Risk Management (ISO 14971)

Technical and strategic consulting, with tailored independent review services

Training, coaching and mentoring

Leading early-stage drug development – seamless and efficient transition through preclinical and into human trials

Clinical development strategy and building KOL networks

Regulatory strategy and interactions with regulatory agencies

CRO and CDMO selection and management

Commercialisation support for lab tools, products and services

Product development, launch and ongoing product management

Market research, application areas and voice of the customer

Scientific writing for sales, marketing and application notes

Employment legislation & compliance

Strategic & operational partner for all your people needs

Establishing & maintaining great cultures

Enhancing engagement & internal communications

Computational/cheminformatics support for drug discovery, including biologicals, ADCs, degraders and RNA

AI/ML use for drug discovery support

Strategic advice on comp chem set-up/recruitment

Structure/sequence searches to support regulatory submissions

Marketing strategy 

Marketing communications

Marketing plans for product launch

LinkedIn marketing for business profiles

Medical and scientific writing

Health literacy campaigns and educational content creation

LinkedIn strategy for science communication and professional branding

Training and mentorship in medical writing and freelance career development

Scientific and medical communication (talks, posters, patient materials, etc.)

LinkedIn strategy and ghostwriting (posts and carousels)

Pitch decks, corporate presentations

Website contents

Target ID & validation package design & management

Scientific strategy and project / CRO / team management

Assay development & screening cascade design & troubleshooting

Translational study management

Clinical project management

Clinical trial management

Clinical operations management

Study and Vendor oversight

Press release drafting for a wide range of announcements

Media outreach: strategy + pitch drafting + journalists/editors pitching

MedComm deliverables: blogs, articles, newsletters, award applications, web copy, social media posts

Pitch deck optimization

Build NGS pipelines that turn raw RNA-Seq, single-cell, or ATAC-Seq data into clear biological answers.

Train ML models for patient stratification, diagnostics, and automated scientific workflows.

Engineer scalable, reproducible data systems tailored to bioinformatics.

Automate research with agentic LLMs and lab-in-the-loop tools that cut effort and speed decisions.

Commercial support for start-up/small companies

Sales Leadership and mentorship

Business development, lead generation, and deal negotiation

Asset pitch and Investment pitch review

Strategic and internal communications, and influence of company cultures

Translate complex scientific stories into clear, compelling communications that connect with target audiences

Creative and strategy pipelines - I can innovate creative content, tactics and strategy

Support drug discovery efforts from lab to trial with end-to-end scientific insight and operational expertise

Craft clear, compelling biotech narratives that resonate with stakeholders

Translate complex science into clear, action-driving messaging

Guide communications through change, uncertainty, and growth with clarity and purpose

Facilitate insight-driven workshops that unlock alignment and drive momentum

Scientific consultancy in AAV gene therapy, stem cell therapies, and bioengineering

Expert advisory and support for securing research funding

Strategic proposal reviews for competitive UK and EU funding schemes

Coaching, training, and workshops for researchers and teams

Bioinformatic analysis and interpretation of RNA-Seq data

Scientific and medical writing for publications, grants, and regulatory documents

Expert analysis of clinical and preclinical data for biotech and pharma

Peer-review support and editing to meet high-impact journal standards

Developing and executing biotech venture strategies to drive growth and investment readiness

Conducting due diligence and market analysis to assess opportunities and mitigate risks

Providing company-building expertise, including operational setup and scaling strategies

Supporting biotech companies with strategic leadership and operational oversight in a fractional capacity

Delivering Global Strategic Solutions

Clinical Development & Operations

Project & Programme Management

Fractional Leadership & Strategic Advisor

Project & Change Management to support Preclinical and Clinical business initiatives

Extensive Pharma and Biotech experience to swiftly assimilate the current state and future goals

Tailoring communications and activities to achieve Client success

Positive about People and Projects; effective delivery with the team at its heart

Customer Support strategy tailored to company size, products and sales forecast.

Building, scaling-up or optimising Customer Support teams and operations

Systems and AI assessment for Customer Support operations

Developing training plans and documentation related to Customer Support teams and operations

Business strategy for start ups

Quality and regulatory strategy for medtech 

Building executive presence for leaders

Exec coaching for leaders and future leaders

Strategic translational science advice

Overall business and financial strategy consulting

Overall strategic development (preclinical, clinical, manufacturing)

Strategic presentation advice

Marketing strategy on social media

Content creation adapted to your audience

Audience and customer understanding

Personal branding for scientist leaders or CEO

GxP QA support and consultation 

Auditing and Inspection Readiness 

eQMS selection and implementation 

Sterility Assurance Assessments