Fractional Chief Medical Officer (Neurology)

A highly experienced neurologist with over 20 years dedicated exclusively to CNS and psychiatric indications. Combines clinical leadership with strong investor-facing experience, regularly engaging with VC stakeholders and supporting fundraising strategies. Well-suited to fractional or advisory roles, bringing immediate strategic impact across early- to mid-stage biotech environments.

Skills & Experience:

• Deep CNS expertise across neurology & psychiatry
• Proven experience supporting VC fundraising cycles
• Strategic advisory for early- and mid-stage biotech
• Clinical development planning and asset positioning
• Board and investor stakeholder engagement

Chief Medical Officer (Ophthalmology)

A seasoned ophthalmology leader with over 30 years of experience, including leading the development of one of the highest-grossing ophthalmic treatments globally. Proven ability to guide programmes from preclinical through to Phase IV, aligning clinical strategy with regulatory and commercial goals. Brings deep therapeutic expertise alongside a consistent track record of accelerating development timelines.

Skills & Experience

• Led development of a global blockbuster ophthalmic drug
• Full lifecycle leadership: preclinical → Phase IV
• Deep expertise in retinal and ocular indications
• Strong regulatory strategy and submission experience
• Track record of accelerating development timelines

Senior Clinical Project Manager

A clinical operations specialist with 25+ years of experience, including significant time within small biotech environments. Deep expertise in hemato-oncology across multiple indications (myeloma, lymphoma, leukaemia), spanning Phases I–IV. Notably accelerated a product timeline by one year at a large pharma company, earning direct recognition from executive leadership.

Skills & Experience

• 25+ years across global clinical operations
• Hemato-oncology expertise across Phases I–IV
• Strong experience within small and emerging biotechs
• Proven ability to accelerate study timelines
• Stakeholder management across CROs and sponsors

Clinical Research Associate

A highly experienced CRA with over 25 years in clinical operations, spanning Class I, II, and III medical device studies. Has worked across more than 40 device trials and held lead responsibility on global studies, including a large Phase I/II COVID trial. Brings hands-on leadership in site management, CRA oversight, and study execution across high-pressure environments.

Skills & Experience

• Experience across Class I, II & III device trials
• Led global Phase I/II COVID clinical study
• Extensive site monitoring and management expertise
• CRA team leadership and oversight
• Strong regulatory and compliance knowledge (GCP)

Clinical Project Manager

A clinical project manager with over 20 years’ experience across medical device trials, including coronary stents and injectable technologies. Strong international exposure across Europe and the US, regularly managing cross-border studies and KOL relationships. Known for maintaining strong site engagement and ensuring consistent delivery across complex, multi-site programmes.

Skills & Experience

• Managed multi-country clinical trials across EU & US
• Expertise in cardiovascular and device studies
• Strong KOL and site relationship management
• Cross-functional coordination and vendor oversight
• Consistent delivery across complex global programmes

Medical Director

An MD-qualified Medical Director with over 20 years of experience across dermatology, immunology, and respiratory. Has led end-to-end medical affairs strategy across the full product lifecycle, from pre-launch planning through to post-launch optimisation. Brings strong expertise in scientific narrative development, advisory boards, and global KOL engagement.

Skills & Experience

• End-to-end medical affairs leadership
• Pre-launch, launch, and post-launch strategy
• Global KOL engagement and advisory boards
• Scientific narrative and communication strategy
• Cross-functional alignment with commercial teams

Senior Medical Advisor

A medical affairs professional with 12+ years of experience across EU5, MER, and EEMEA regions. Specialises in cardiovascular therapies, with direct involvement in product launches including NOAC treatments. Strong track record in stakeholder engagement, patient-focused initiatives, and supporting medical strategy across both pre- and post-launch phases.

Skills & Experience

• Experience across EU5, MER & EEMEA markets
• Cardiovascular therapeutic expertise
• Product launch and lifecycle support
• Stakeholder and patient engagement initiatives
• Cross-regional medical strategy execution

Clinical Scientist (Neuro)

A PhD-trained neuropsychologist with over 20 years of experience across neurodegeneration, psychiatry, and neuropsychology. Brings hands-on expertise across a wide range of CNS indications, including Alzheimer’s, Parkinson’s, and autism spectrum disorders. Offers a unique combination of clinical development leadership and digital health integration, particularly in cognitive and behavioural endpoints.

Skills & Experience

• Deep CNS expertise across multiple indications
• Specialisation in cognitive and behavioural endpoints
• Clinical development leadership experience
• Integration of digital health tools and data
• Strong academic and translational background

Clinical Scientist (Vaccines)

A translational vaccine scientist with deep expertise across mRNA, adjuvanted, and protein-based platforms. Has led programmes across major infectious diseases including influenza, TB, malaria, RSV, and COVID-19. Strong focus on immunology, biomarker strategy, and mechanism-of-action studies, supporting next-generation vaccine development.

Skills & Experience

• Expertise across mRNA and vaccine platforms
• Infectious disease portfolio leadership
• Biomarker strategy and immune profiling
• Systems vaccinology and MOA studies
• Clinical immune response and data interpretation

Chief Medical Officer

A pioneering clinical leader involved in the first gene therapy approved in the Western world (Glybera®), successfully overturning an initial negative EMA opinion. Brings over 25 years of experience across ATMPs, including gene and cell therapies, RNA therapeutics, and biologics. Has contributed to multiple regulatory approvals and specialises in translating complex science into successful clinical and regulatory outcomes.

Skills & Experience

• Led first approved gene therapy programme (EU)
• Extensive FDA & EMA regulatory experience
• ATMP, gene therapy, and RNA expertise
• Rare disease and paediatric development
• Translational strategy from preclinical to approval

Analytical Development SME

An analytical development specialist with 15+ years of experience across monoclonal antibodies, biosimilars, and gene therapies. Brings deep regulatory expertise, having supported multiple BLA submissions and FDA inspections. Has played a key role in late-stage development, ensuring analytical strategies align with regulatory expectations and commercial readiness.

Skills & Experience

• Analytical lead across mAbs, biosimilars, and gene therapies
• Direct support for BLA filings and regulatory submissions
• Managed 10+ late-stage stability programs (Phase III → commercial)
• Strong experience in FDA pre-approval inspections (PAI)
• Proven track record of zero critical findings during inspections
• Expertise in method validation, transfer, and lifecycle management
• Data integrity and compliance across global submissions

Drug Substance SME

A drug substance expert with 19 years of biologics development experience, specialising in monoclonal antibodies and CHO-based manufacturing processes. Extensive background across downstream processing, supporting programmes from early clinical stages through to BLA submission. Known for ensuring processes are robust, scalable, and fully aligned with regulatory expectations.

Skills & Experience

• Deep expertise in monoclonal antibody development
• CHO-based upstream and downstream process knowledge
• Advanced chromatography (Protein A, IEX, HIC, mixed-mode)
• Filtration systems including UF/DF and depth filtration
• Process characterisation, validation, and PPQ readiness
• End-to-end DSP lifecycle management
• Strong regulatory alignment for BLA submission

Process Development SME

A highly experienced process development leader with over 30 years in protein-based therapeutics. Played a key SME role in the Keytruda BLA submission at Merck, supporting both drug substance and drug product activities. Brings extensive experience across IND-enabling work through to successful BLA/MAA submissions, alongside strong CMC leadership within biotech environments.

Skills & Experience

• Led process development for Keytruda BLA submission
• 30+ years across biologics and protein therapeutics
• Supported 15+ IND programmes and 3 BLA/MAA approvals
• Strong expertise in Module 3 (CMC) authoring
• End-to-end DS & DP process development oversight
• CMC strategy for preclinical → Phase II transition
• CDMO selection, negotiation, and global management
• Advisory support to EU & US biotech scaling programmes

Clinical Evaluation / Medical Writing Consultant

A medical device writing specialist with 6+ years’ experience delivering high-quality regulatory documentation across Class I–III devices. Extensive track record in CERs, PMCF, and post-market documentation aligned to MDR 2017/745. Also brings hands-on clinical investigation experience, supporting protocol development through to regulatory submission.

Skills & Experience

• Authored 100+ CERs, CEPs, BEPs, PMCF & PSURs
• Strong MDR & MEDDEV compliance expertise
• Managed Class III clinical investigations
• 510(k) submission support experience
• Regulatory writing across full product lifecycle

Clinical / Regulatory Submissions Writer

A highly experienced regulatory writer with 30 years across pharma, biotech, and CRO environments. Has supported biotech companies from first-in-human protocol development through to Phase III submissions. Deep expertise across oncology, rare disease, and gene therapy, with a strong advisory approach to regulatory strategy and documentation.

Skills & Experience

• End-to-end clinical & regulatory writing (IND → Ph III)
• CTDs, CSRs, IBs, IMPDs, Briefing Books
• 18+ years dedicated regulatory writing experience
• Strong oncology, rare disease, gene therapy focus
• Advisory on templates, guidelines, and submission strategy

Quality Assurance Manager

A QA leader with strong experience across sterile manufacturing environments, including fill-finish and tech transfer activities. Has full ownership of Quality Management Systems aligned to GMP and GDP standards. Brings hands-on experience managing CMOs and ensuring compliance across supply chain and distribution activities.

Skills & Experience

• Full QMS ownership (GMP, GDP, EudraLex Vol. 4)
• Sterile manufacturing & fill-finish expertise
• CMO oversight and tech transfer experience
• Temperature excursion and distribution compliance
• Strong quality systems implementation and governance

Quality Consultant (Radiopharma)

A quality consultant with specialist expertise in radiopharmaceuticals, providing end-to-end QA leadership across complex manufacturing and regulatory environments. Strong focus on deviation management, CAPA, and change control, supporting organisations through both BAU operations and remediation projects.

Skills & Experience

• Radiopharmaceutical QA expertise
• End-to-end quality assurance leadership
• CAPA, deviation, and change control management
• Regulatory compliance and audit readiness
• Support across manufacturing and supply chain QA

QA Manager / GCP Auditor

A highly experienced GCP auditor with over 185 audits conducted across Phases I–IV. Extensive global inspection experience across Europe, the US, and emerging markets. Known for preparing sponsors, CROs, and sites for successful regulatory inspections with a strong focus on compliance and risk mitigation.

Skills & Experience

• 185+ GCP audits (Lead & Co-Auditor)
• Global audit exposure across EU, US & APAC
• FDA & EMA inspection readiness
• CRO, sponsor, and site audit expertise
• Risk identification and compliance strategy

Pharmaceutical Field Service Engineer

A field service engineer with strong experience supporting pharmaceutical manufacturing and lab environments. Focused on continuous improvement and lean initiatives, with deep exposure to lab systems, tech transfer, and inspection readiness. Plays a key role in maintaining operational efficiency and compliance.

Skills & Experience

• Continuous improvement and lean leadership
• Lab systems installation and optimisation
• Tech transfer and operational support
• Data integrity and compliance focus
• Inspection readiness across manufacturing sites

Chief Medical Officer (Ophthalmology)

A board-certified ophthalmologist with over 25 years of experience, specialising in gene therapies targeting inherited retinal diseases. Has led programmes from preclinical through to Phase III, combining deep clinical expertise with strong development leadership in highly specialised ophthalmic indications.

Skills & Experience

• Gene therapy expertise in retinal diseases
• Full lifecycle clinical development leadership
• Ophthalmology specialist (25+ years)
• Clinical strategy and protocol design
• Cross-functional leadership in biotech settings

Chief Medical Officer (Neurology)

A highly experienced neurologist with over 35 years across neurology, neuroradiology, and CNS. Brings hands-on leadership across full lifecycle development, from early research through to Phase IV studies. Strong track record of driving complex CNS programmes forward.

Skills & Experience

• Deep CNS expertise across multiple indications
• Full lifecycle development (preclinical → Phase IV)
• Neurology and neuroradiology background
• Clinical strategy and execution leadership
• Experience across global development programmes

Medical Director (Oncology & Haematology)

A board-certified oncologist and haematologist with strong experience leading global clinical trials across Phases I–III. Has worked closely with regulatory authorities, including direct experience within an agency environment, bringing a unique perspective on regulatory expectations and trial design.

Skills & Experience

• Global oncology and haematology trials
• Phase I–III study leadership
• Regulatory authority experience
• Protocol design and execution
• Cross-functional clinical leadership

Director Clinical Operations

A senior clinical operations leader with over 30 years of experience across global clinical research. Has led multiple first-in-human oncology studies, consistently delivering on time, within budget, and with zero audit findings. Strong expertise in CRO selection and oversight across Europe and the US.

Skills & Experience

• First-in-human oncology study leadership
• CRO selection and vendor management
• Global trial delivery across EU & US
• Strong compliance track record (zero findings)
• Budget, timeline, and risk management

Senior Project Manager 

A senior project manager with strong experience leading Phase II–IV clinical trials across multiple therapeutic areas. Known for driving cross-functional collaboration and ensuring projects are delivered on time and within budget, while maintaining high quality and compliance standards.

Skills & Experience

• Phase II–IV trial management
• Cross-functional leadership
• Budget and timeline ownership
• Risk management and mitigation
• Stakeholder and vendor coordination

Senior Clinical Research Associate 

An experienced CRA with over 15 years across all phases of clinical trials. Has conducted all types of site visits and built strong relationships with investigators and site staff. Known for ensuring high standards of data quality, compliance, and smooth study execution.

Skills & Experience

• Pre-study to close-out site visits
• Strong ICH-GCP compliance
• Site relationship management
• Data quality and patient safety focus
• Issue resolution and site support

Senior Clinical Research Associate

A highly experienced CRA with 26 years of global clinical research experience across both medical device and pharmaceutical trials. Has led studies across multiple continents and therapeutic areas, combining strong operational leadership with deep compliance expertise.

Skills & Experience

• Global trial experience (US, EU, LATAM, APAC)
• Multi-therapy expertise (oncology, cardio, neuro)
• CRA team leadership and mentoring
• Strong GCP and audit experience
• EDC, CTMS, and data systems expertise

Associate Director Clinical Operations / CTM

A clinical operations leader with strong expertise in rare disease trials, particularly within dermatology and immunology. Has managed global studies across multiple regions, with a strong focus on patient recruitment and retention in hard-to-reach populations.

Skills & Experience

• Rare disease trial management
• Global CRO and vendor oversight
• Patient recruitment strategy development
• Cross-functional leadership
• Study planning and documentation

Director Clinical Operations (Ophthalmology)

A clinical operations director with 20+ years of experience leading ophthalmology trials, including gene and cell therapy programmes. Strong expertise in first-in-human studies and complex ocular procedures, with a focus on safety, compliance, and delivery.

Skills & Experience

• Ophthalmology and retinal disease expertise
• First-in-human study leadership
• Gene and cell therapy trial experience
• IND and regulatory support
• Vendor and team leadership

VP Clinical Development/CMO

A senior clinical leader with MD/PhD credentials and extensive experience across oncology and haematology. Has led multiple global programmes from early development through approval, with a strong track record of regulatory success.

Skills & Experience

• 7 NDA and 12 IND submissions
• Global oncology programme leadership
• Expertise across solid tumours and haematology
• Advanced therapies (CAR-T, ADCs, IO)
• Regulatory strategy and execution

Chief Medical Officer (Neurology)

A neurologist and experienced CMO with a strong track record across global CNS programmes. Successfully turned around a failing Phase IIb Alzheimer’s study, demonstrating strong leadership in complex and high-risk development environments.

Skills & Experience

• Global regulatory experience (FDA, EMA, APAC)
• CNS expertise across multiple indications
• Clinical turnaround and rescue strategy
• NDA and IND leadership
• Broad therapeutic exposure beyond CNS

Medical Monitor

A highly experienced medical monitor with 25+ years across clinical development and drug safety. Has led large global studies across multiple therapeutic areas, with strong expertise in regulatory submissions and safety reporting.

Skills & Experience

• Global study oversight (1,500+ patients)
• IND, NDA, BLA, CSR preparation
• SAE/SUSAR and safety reporting
• Multi-therapy clinical expertise
• Regulatory authority interactions

Head Of Biometrics 

A senior biometrics leader with over 25 years of experience across pharma and biotech. Has built and scaled biometrics functions within emerging biotechs, combining strategic leadership with hands-on technical involvement.

Skills & Experience

• Biostatistics, programming & data management leadership
• Function build and team scaling
• Study design and statistical strategy
• Cross-therapy expertise
• Hands-on VP-level execution

Clinical Data Manager

A clinical data management leader with strong experience overseeing global DM activities and system implementation. Has led database development and partnered across functions to ensure study delivery and data integrity.

Skills & Experience

• Database build and validation oversight
• Global SOP development
• UAT and system deployment
• Cross-functional collaboration
• Portfolio and asset management

MSL/Medical Advisor

A PhD-qualified MSL with 12 years of experience across Europe and the Nordics. Strong KOL network across neuroscience, oncology, and rare disease, with a proven track record supporting multiple product launches.

Skills & Experience

• KOL engagement across EU & Nordics
• 13 product launches supported
• Medical affairs strategy support
• Cross-therapy expertise
• Interim consultancy experience

Medical Lead/Medical Director 

A senior medical affairs leader with over 20 years of experience across global markets. Has led multiple product launches and built medical information and operations functions from the ground up.

Skills & Experience

• Global medical affairs leadership
• Product launch strategy and execution
• KOL identification and engagement
• Medical information systems setup
• Pharmacovigilance and reporting

Medical Information Specialist

A medical information specialist with 12 years of experience managing medical information systems and responding to complex queries. Strong experience in SOP development and CRM systems including Veeva.

Skills & Experience

• Medical information systems management
• SOP writing and implementation
• Veeva CRM expertise
• Query handling and response development
• Cross-functional support

Creative Director (Art)

A senior creative director with over 30 years in healthcare communications, leading major brand launches and disease awareness campaigns. Combines strategic leadership with hands-on execution across design and concept development.

Skills & Experience

• Healthcare brand and campaign leadership
• Product launch experience
• Art direction and creative execution
• Disease education initiatives
• Cross-functional collaboration

Senior Medical Writer / Scientific Director

A scientific director with over 20 years of experience across medical writing and communications. Has led content strategy across multiple therapeutic areas, supporting both branded and unbranded campaigns.

Skills & Experience

• Medical writing across 100+ products
• Scientific strategy and content leadership
• MedEd, HCP, and payer materials
• Team leadership and KOL engagement
• US & EU compliance

Senior Medical Writer

A highly experienced medical writer with authorship across 200+ publications. Strong expertise in hepatology, oncology, and rare diseases, working closely with KOLs and cross-functional teams.

Skills & Experience

• 200+ manuscripts and publications
• Therapeutic expertise across multiple areas
• Scientific communication and storytelling
• KOL and investigator collaboration
• Regulatory and medical affairs alignment

Chief Technology Officer (SaMD / AI)

A fractional CTO specialising in AI-driven medical devices and regulated software. Has led end-to-end development of CE-marked SaMD products, combining deep technical expertise with executive leadership.

Skills & Experience

• AI/ML product development
• SaMD regulatory compliance (MDR, IEC standards)
• Cloud architecture and data governance
• Software development lifecycle leadership
• Executive-level strategy and delivery

Principal Bioinformatics Consultant

A bioinformatics leader with strong experience across genomics, sequencing, and cloud-based platforms. Has built scalable data pipelines and led teams within both startup and large pharma environments.

Skills & Experience

• Genomics and sequencing expertise
• AWS and cloud-based infrastructure
• Pipeline development and optimisation
• Cross-sector experience (startup → pharma)
• Team leadership and project delivery

Senior MSAT Consultant

A senior MSAT consultant with advanced therapy experience across CAR-T manufacturing, regulatory approvals, and commercial launch. Has supported the launch of three commercial therapies and played a key role in FDA, EMA, and EU GMP approvals. Strong hands-on capability across tech transfer, site readiness, deviation management, and live GMP manufacturing support.

Skills & Experience

• CAR-T and advanced therapy manufacturing
• FDA, EMA, and EU GMP approval support
• Site start-up and operational readiness
• MSAT function build-out
• Tech transfer and commercial ramp-up
• Deviation, CAPA, and change control leadership
• GMP troubleshooting and patient supply continuity

Senior Supply Chain Consultant 

A senior supply chain consultant with strong international launch and logistics experience across EMEA. Has successfully led product launches in more than 20 countries and repeatedly managed RFPs, distributor selection, 3PL implementation, and global logistics optimisation. Brings a strong commercial lens, delivering measurable cost savings through network redesign and contract negotiation.

Skills & Experience

• Product launches across 20+ EMEA countries
• Distributor and 3PL selection
• RFP management and contract negotiation
• Global sourcing and logistics optimisation
• Freight and network redesign projects
• Supply chain cost reduction
• Cross-functional launch planning

Senior Biopharma MSAT Consultant

A senior biopharma MSAT consultant with 15+ years leading process characterisation, tech transfer, validation, and lifecycle support across biologics and vaccines. Has delivered scale-up from AMBR through to 18,000L bioreactors across global CDMO networks. Combines hands-on technical depth with regulatory documentation experience across IND, IMPD, MAA, and BLA submissions.

Skills & Experience

• Biologics and vaccine MSAT leadership
• Process characterisation and validation
• Scale-up from AMBR to 18,000L bioreactors
• Global tech transfer across CDMO networks
• IND, IMPD, MAA, and BLA documentation
• DoE, MVDA, digital twins, and QbD frameworks
• Deviation management and process improvement

Technical CMC Writer

A highly experienced technical CMC writer with an exceptional track record across global regulatory submissions. Has authored and reviewed more than 600 CMC submissions, including INDs, BLAs, MAAs, and NDAs. Notably achieved zero FDA/EMA queries for major tech transfer and submission programmes, including Zoloft and Eliquis-related work.

Skills & Experience

• 600+ CMC submissions authored/reviewed
• IND, NDA, BLA, and MAA writing
• 10+ NDA submissions supported
• Zero FDA/EMA query track record
• Small molecule CMC expertise
• Global site transfer and post-approval filings
• Support for biotech IND and CMC pathways

Regulatory Project Manager

A regulatory project manager with deep experience leading complex global submissions across oncology and immunology assets. Led submission activity for 11 indications of TEVIMBRA across 48 countries and coordinated BeOne’s first three global INDs before building a team that delivered 28 INDs worldwide. Strong at managing senior stakeholder reporting, timelines, risks, and regulatory process improvement.

Skills & Experience

• Led submissions across 48 countries
• Managed 11 indication filings for TEVIMBRA
• Built and led team delivering 28 global INDs
• IND, NDA, MAA, and global filing experience
• FDA, EMA, China, and regional requirements
• Regulatory timeline and risk management
• Submission workflow and template standardisation

Formulations & Process Development Consultant

A senior formulations and process development consultant with 29+ years of experience across oral dosage forms, peptides, proteins, and small molecules. Recognised as a KOL in oral peptide/protein delivery and advanced formulation technologies. Has provided CMC leadership from discovery through Phase II/III and commercialisation, including scale-up of two oral products to commercial sites.

Skills & Experience

• Oral peptide and protein delivery expertise
• Formulation and process development leadership
• Discovery through Phase II/III and commercialisation
• Scale-up of two oral products to commercial sites
• ASD/SDD, hot-melt extrusion, lipid-based systems
• Modified-release and taste-masking platforms
• IND, NDA, and post-approval CMC strategy
• Led 25-person pharmaceutics organisation

CMC Technical Writer

A CMC technical writer with broad end-to-end regulatory writing experience across both small molecules and biologics. Brings more than 10 years of CMC technical writing experience, supported by 15 years in small molecules and 10+ years in biologics. Holds an MSc in Regulatory Science and has led CMC writing strategy across major global submission types.

Skills & Experience

• CMC writing across small molecules and biologics
• DMF, CTA, IMPD, IND, BLA, MAA, NDA, JNDA, ANDA
• CMC strategy and submission planning
• Regulatory science background
• End-to-end technical writing support
• Global submission documentation

GCP Auditor

A GCP auditor with strong FDA-aligned quality and inspection expertise. Has performed gap assessments on FDA quality management systems and received FDA training in clinical investigations and BIMO compliance enforcement. ASQ-certified and conducts more than 20 GCP audits annually.

Skills & Experience

• FDA-trained in clinical investigations
• BIMO compliance enforcement knowledge
• ASQ Certified Auditor
• 20+ GCP audits per year
• Gap assessments and QMS review
• Clinical audit and inspection readiness
• Sponsor, CRO, and site audit support

CSV Consultant

A CSV, quality, and data integrity consultant with broad experience across GCP, GMP, GLP, medical device, animal health, and laboratory operations. Strong track record supporting and hosting MHRA and FDA inspections, including front- and back-room inspection activity. Experienced in validating and implementing regulated systems across clinical, lab, and enterprise environments.

Skills & Experience

• CSV and data integrity leadership
• 21 CFR Part 11 compliance
• MHRA and FDA inspection support
• Audit readiness and remediation
• SOP development and CAPA execution
• EDC, CTMS, LIMS, ELN, SAP ERP, and Veeva
• GCP, GMP, GLP, medical device, and lab operations

CMO and CEO

A senior executive and clinical leader with experience taking a therapeutic cancer vaccine from preclinical development through Phase III. Has contributed directly to successful IPO activity and played a key leadership role in securing over $200M in Series B funding. Strong global regulatory exposure across FDA, EMA, PMDA, and other authorities.

Skills & Experience

• Therapeutic cancer vaccine leadership
• Preclinical through Phase III development
• IND and CTA acceleration
• IPO and investor-facing experience
• FDA, EMA, PMDA, and global regulatory exposure
• CMO/CEO-level strategic leadership
• Oncology programme and fundraising strategy

COA Expert (Neuro & Rare)

A PhD-qualified COA expert with 20 years’ experience exclusively across neuroscience indications. Deep expertise across narcolepsy, idiopathic hypersomnia, sleep apnoea, Alzheimer’s, Parkinson’s, ALS, bipolar disorder, major depressive disorder, and schizophrenia. Strong track record in COA development, validation, regulatory engagement, and digital health strategy.

Skills & Experience

• 20 years’ neuroscience COA experience
• Phase I–IV COA strategy
• COA development and validation
• FDA and EMA regulatory engagement
• PRO/PCO research and evidence generation
• Digital health technology strategy
• Scientific publication track record

COA Expert (Consulting)

A PhD psychologist with over 10 years’ experience in COA selection, development, refinement, and interpretation. Strong methodology expertise across patient-centred research, psychometrics, and regulatory-facing COA dossiers. Has supported rare disease, paediatric, neurodegenerative, and immunology programmes, with a strong publication and conference profile.

Skills & Experience

• COA selection, development, and validation
• Qualitative, quantitative, and psychometric studies
• Rare disease and paediatric COA expertise
• Alzheimer’s, Parkinson’s, Huntington’s experience
• Briefing packages and COA dossier preparation
• Regulator engagement for PRO inclusion
• 25+ peer-reviewed publications
• Novel PRO instrument co-creation

COA Expert (Immunology)

A senior COA expert with more than 20 years’ experience developing and supporting COA strategies, contributing to over 50 label claims. Strong track record gaining FDA and EMA approval, with extensive expertise across immunology conditions including CLE, SLE, systemic sclerosis, atopic dermatitis, CSU, CINDU, and cold urticaria. Also brings leadership experience across COA teams and emerging AI-enabled strategy.

Skills & Experience

• 20+ years COA research and strategy
• 50+ label claim support
• FDA and EMA approval track record
• ClinRO development and validation
• Immunology and dermatology COA expertise
• COA measure selection, modification, and validation
• Team leadership, mentoring, and training
• AI, ML, LLM, NLP, and robotics business strategy focus

A freelance health economist with 7+ years’ experience across health economics, public health, macroeconomics, and data analysis. Strong capability in health economic modelling, systematic reviews, and evidence generation to support complex HTA challenges. Has independently developed 11 HEOR models from scratch and supported 20+ additional models across multiple methodologies.

Skills & Experience

• Health economic modelling
• Cost-effectiveness and budget impact models
• Decision tree, cost minimisation, cost-utility, and DTM models
• Systematic literature reviews
• Data analysis and public health insight
• HTA evidence development
• Freelance support across pharma, biotech, and medical device projects