Nigel Mclean Email and Phone Number
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A highly experienced hands-on and results driven enabler with a successful track record of project/program/portfolio/product and innovation management, business development, technology transfer, and contract negotiation in UK, EU & USA. Adopting a customer centric approach with an in-depth technical and business approach, I lead teams to develop and bring award winning products to market that are positioned to meet user demands, and regulatory requirements, and primed to maximize market penetration and profit generation.- PRODUCT MANAGEMENT: developed product strategy, go-to-market plan and promotional material for an in vitro diagnostic for bladder bladder cancer, implemented a TeleMedicine service with the Technology Integration team at Kaiser Permanente.- PROJECT / PROGRAM MANAGEMENT; coordinated manufacture (UK & EU suppliers) and service provision for an in vitro diagnostic product; managed CE marking of four IVD tests and launch of one.- BUSINESS DEVELOPMENT; developed business cases and implement commercialisation strategies through forming mutually beneficial collaborations, licensing, grants, and company formation, in the fields of diagnostics, software, biotech and medtech products; negotiated collaborations with biotech, medtech and pharma.- CLINICAL TRIAL MANAGEMENT: agreed a 510K and PMA strategy for a digital pathology in vitro diagnostic for bladder cancer via “pre-sub” face-to-face meetings with FDA; set up the UK clinical performance and health economics study, configured cloud based eCRF for NHS sponsored clinical trial, recruited sites in USA and negotiated win-win agreements. Principle Investigator for a USA Centre for Medicaid & Medicare Services trial in Kaiser Permanente. Previous experience:• Board Member of Kaiser Permanente MidAtlantic Medical Group Innovation Institute; improving healthcare efficiency, best practice and quality through innovation• Reviewer for Maryland Biotechnology Centre - Commercialization and Translational Research Awards• Certified in Epic Care Ambulatory Electronic Medicine Records - responsible for coordinating with clinical leads throughout Kaiser Permanente the management of consultations and referrals.• Observer on Board of Directors of an orthopaedic spin-out• Member of The Alternative Board• Genesis Innovation Technology Award 2011 winner. • Winner of the Scottish Enterprise Life-Science Award for best innovation emanating from NHS Scotland in 2010 and 2012.
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Translational Product ManagerTay Health TechNewport-On-Tay, Gb
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Head Of ProjectsExotopic Sep 2023 - PresentCity Of London, England, GbEXOTOPIC : HEAD OF PROJECTS (2023-)Management consultancy for company formation, product development, GoToMarket strategies.• Manage a £3million Innovate grant. Demonstrated exceptional leadership in guiding product development and market introduction, collaborating closely with engineers, manufacturers, and key industry partners across medtech, defence, aerospace, and telecommunications sectors, ensuring the product's alignment with end-user needs. Produced progress reports to the funding agency ensuring timely payment of Claims; communicated risks together with solutions for mitigating and resolving issues.• Negotiated collaboration agreements with seven subcontractors enhancing operational efficiency and project deliverability in complex, multi-sector environments. • Played a pivotal role in an EU consortium, conducting comprehensive market analysis and crafting a strategic business case for a novel communications technology aimed at revolutionizing healthcare, transport, and environmental surveillance, showcasing adeptness in cross-functional team leadership and market innovation.
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Entrepreneurial Mentor & AgitatorElevator Uk 2019 - PresentBridge Of Don, Scotland, GbVolunteer : Challenging and advising founders of new ventures on their business model and go-to-market strategy. Proactively helping to guide the company towards a sustainable and profitable future. -
Program ManagerOxford Cancer Biomarkers Nov 2022 - Sep 2023Develops and markets precision medical diagnostics for unparalleled clinical decision making.• Led the strategic planning and execution of precision medical diagnostics development, achieving CE marking for key products by adhering to clinical, pathology, commercial, and regulatory standards, thereby enhancing customer satisfaction. • Set up a clinical utility study within clinical oncology and pathology departments plus health-economic study, in England and Scotland to demonstrate the value proposition of a newly developed digital pathology product. Work with internal CI & external PI's, to compete IRAS application, protocol, risk register, budget, resources, milestones and Deliverables.• Identified and capitalized on product improvement opportunities through in-depth healthcare staff discussions and regulatory guideline analysis, securing expanded regulatory clinical claims that maximized NHS, patient, and commercial benefits.• Using competitive intelligence and product performance data, work with marketing to create promotional material and GoToMarket launch strategy. Work with the CEO and team to develop investor pitches to attract new business partners and investment. -
Global Program ManagerLumiradx Apr 2021 - Nov 2022London, London, GbBased in the Programme Delivery Office working closely with a global multi-disciplinary team, I help navigate the development of LumiraDx highly innovative products from concept through to product launch. In 2022 gaining CE mark for three point of care products and launching one in Q1 of 2022.Ensuring effective and efficient communication between executive management and all functions including Product Management, R&D, RA/QA and Operations, in our fast paced and rapidly evolving industry, we pivot where necessary to produce top quality products that meet the needs and wants of our customers and shareholders. -
Network ExpertBiocity 2019 - 2022Nottingham, Nottinghamshire, Gb -
Senior Project Manager : Division Qa Ra PmoAbbott Rapid Diagnostics Jun 2020 - Apr 2021• Directed and oversaw comprehensive project management within the Division of Quality & Regulatory Project Management Office, enhancing ARDx's manufacturing and commercial operations across cardiometabolics, infectious disease, and toxicology units in the EU and USA, as measured by the successful alignment with IVDR/MDR and UKCA standards,• Maintained all documentation according to a highly regulated QMS including RAID logs, RACI matrixes and tailored communication which facilitated the seamless dissemination of critical information to all stakeholders in the correct format and time frame.• Formed strong partnerships with remote, globally located stakeholders including Business Unit leaders, CRO’s, contractors, shared services leads and Division functional leaders, throughout Abbotts global manufacturing, distributing and marketing family of companies
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Technology Transfer ManagerUniversity Of Dundee, Research & Innovation Services 2019 - Jun 2020Driving translation and commercialisation of the world leading research emanating from University of Dundee through licensing and venture creation. • Championed the promotion of cutting-edge technologies at major industry events, significantly enhancing visibility and attracting strategic collaborations and licensing opportunities, as demonstrated by the production and dissemination of impactful marketing materials.• Orchestrated multi-sector collaborations, leading to the successful negotiation of contracts and licensing agreements with industry, NHS, and academic partners, thereby facilitating the commercialization of innovative medical and surgical devices
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Director Product Management & CommercialisationCytosystems Ltd 2015 - 2019Cytosystems is a ISO13485 accredited, clinical stage diagnostic SME, focused on the development of products for diagnosis and prognosis of urological cancers including bladder and prostate cancer. Powered by analytical software developed using AI and machine learning, our first product, BladderLight, incorporates digital pathology techniques to provide clinicians with a highly accurate in vitro risk stratification assay for urothelial cancer. * Took from prototype through to a CE marked, and patented, industrially manufactured single-use medical device for capturing and preserving bladder cells from urine, for use at the out-patient clinic, community hospital, or GP/PCP * Produced a kit containing reagents and biomarkers ready to use by clinical pathology laboratories for our BladderLight assay.* Agreed a 510K and PMA pathway via face-to-face meetings with the FDA * Set up and managed a multi-centered clinical trial within the UK* Initiated a health economic and clinical utility strategy to show efficacy to the EU and USA markets* Initiated a reimbursement strategy for the USA market* Negotiated commercial agreements with UK and USA customers, technical and commercial partners* Developed and presented a business plan to potential investors with our investment team
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Co-Founder - DirectorXxbiotics Ltd. 2009 - 2018- Development of a probiotic product for treatment and prevention of Bacterial Vaginosis. We have sole ownership of a probiotic consortium discovered to have ideal properties for preventing bacterial vaginosis. - McLean NW, Rosenstein IJ, "Characterisation and selection of a Lactobacillus species to re-colonise the vagina of women with recurrent bacterial vaginosis." J.Med. Microbiol 2000; 49: 543-552.
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Business Development ExecutiveEdinburgh Bioquarter - At University Of Edinburgh Mar 2015 - Aug 2015Edinburgh City, GbManage exploitation of IPR emanating from the University of Edinburgh’s College of Medicine and Veterinary Medicine, and foster collaborations with the bio-pharmaceutical industry.• Manage the commercialization strategy for a multi-million pound project developing and testing, in a first-in-man clinical trial, a novel treatment for liver cancer.• Project manage MRC sponsored Confidence in Concept projects in the field of regenerative medicine for Parkinson’s, enhancement of MRI images for diagnosis and stratification of patients with liver disease, breast cancer and brain degenerative diseases.• Gain investment and industrial collaborations to take a novel steroid through Phase I clinical trials. -
Project Manager - Technology IntegrationKaiser Permanente Medical Group 2013 - 2015Oakland, California, UsReporting to the Associate Medical Director within the Mid-Atlantic States responsible for performance improvement, issues resolution, and the efficient and effective functioning of the system that KP’s MidAtlantic States 1,100 Doctors rely on for referring over 530,000 patients to Specialists• Based on UX design and user stories, identify “pinch points” in the patient & customer journey, devise strategies for improving product performance, profitability, & user experience.• Configured the EPIC electronic healthcare IT software App used for referral of patients from primary care to specialist secondary care.• Managed multi-disciplinary teams including underwriting, account management, Medical Directors, marketing, quality, compliance, sales, customer services, and IT to bring new technologies and products to the medical group and insurance side of the business.• As a Board member of the KP Innovation Institute I evaluated and coordinated the development of new customer services and in-house process improvements for the business.• Principle Investigator for a CMS sponsored trial; dermatology, GI, radiology, surgery. -
Product Manager - Strategic Marketing & Business DevelopmentKaiser Permanente Medical Group 2012 - 2013Oakland, California, UsLead the ongoing analysis, planning and management for new and existing products through their product life cycle.- Develop annual product strategic plans- Establish key product metrics and performance goals- Track, evaluate and report on product performance- Through business analysis, primary market research, membership forecasting and ROI analysis realigned product offerings to improve the bottom line- Integral in driving implementation of products for the Healthcare Reform Act and a private exchange
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Business Operations (North)Scottish Health Innovations Ltd. Mar 2011 - Feb 2012Glasgow, Scotland, GbResponsible for:- driving commercialisation of IPR from concept to client approved scope and quality on time and to budget. - creating and managing profitable business ventures through collaborations or licenses with local and global medtech and biotech companies- agreeing and delivering company strategy- aligning project portfolio with corporate strategy- ensuring that internal and external stakeholders expectations are delivered -
Project ManagerScottish Health Innovations Ltd. 2008 - Mar 2011Glasgow, Scotland, GbProject management and business development of IP portfolio under ISO13485 from disclosure through evaluation, planning, preparation of business case, protection, funding, risk management, technical/design dossier management, prototyping, manufacture and clinical trials of regulatory approved products to eventual licensing, new company formation and handover to sales team for direct sales.Business operations; with senior management control project portfolio and company CF, benefits realisation, stakeholder management.
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Business Development ManagerScottish Health Innovations Ltd. Oct 2002 - Oct 2008Glasgow, Scotland, GbResponsible for business development in north Scotland including:- IPR identification and evaluation- developing and commercialising business opportunities through academic and industrial collaborations, licensing and company formation.- stakeholder relationship management- presenting and promoting business opportunities
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Co-Founder And DirectorZone Fit Ltd 2006 - 2012GbDeveloped an exercise device plus group choreography class. The performance of the product was validated with state of the art bio-mechanical engineering techniques by local universities. The award winning product was launched at an international exercise convention by an international celebrity in the field. -
Technology Transfer ExecutiveRowett Research Services Ltd 1999 - 2002Identification, evaluation, management and commercialisation of IP emanating from the Rowett Research Institute through collaborations with industry, in-house development and formation of new companies. Project Portfolio included human and animal health; immunological, molecular biological, microbiological, and nutritional methods of preventing and treating cardiovascular disease, gastrointestinal diseases, disease and syndromes relating to appeptite and weight management.
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Research Fellow; Department Of Medical Microbiology / Diagnostic And Investigative Science.Imperial College London 1998 - 1999London, GbProject entitled "Design of a probiotic consortium for use in a clinical trial to aid in the treatment of bacterial vaginosis”.IPR licensed into a new company, XXBiotics; a product is currently in development under a sub-licence agreement. -
Post Doc. Medical Molecular MicrobiologyGlasgow Caledonian University 1996 - 1998Isolation and characterisation of enzymes involved in the pathology of bacterial vaginosis and preterm birth
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LecturerGlasgow Caledonian University 1995 - 1996
Nigel Mclean Skills
Nigel Mclean Education Details
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Villanova UniversityProject Management -
University Of AberdeenEntrepreneurship
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Glasgow Caledonian UniversityMedical & Molecular Microbiology
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University Of GlasgowMicrobiology
Frequently Asked Questions about Nigel Mclean
What company does Nigel Mclean work for?
Nigel Mclean works for Tay Health Tech
What is Nigel Mclean's role at the current company?
Nigel Mclean's current role is Translational Product Manager.
What is Nigel Mclean's email address?
Nigel Mclean's email address is ni****@****l.co.uk
What schools did Nigel Mclean attend?
Nigel Mclean attended Villanova University, University Of Aberdeen, Glasgow Caledonian University, University Of Glasgow.
What are some of Nigel Mclean's interests?
Nigel Mclean has interest in Science And Technology.
What skills is Nigel Mclean known for?
Nigel Mclean has skills like Medical Devices, Biotechnology, Product Development, Intellectual Property, Project Management, Business Development, Licensing, Strategic Planning, Competitive Analysis, Science, R&d, Product Management.
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