Jonathan P. Taylor, Msc (Sci) Email & Phone Number

United Kingdom

Retired from clinical research and now pursuing musical composition (piano). May be willing to consider interesting, specific and short-term consultancy position(s) in clinical research from April 2021 but for now I am enjoying the creativity that retirement brings.

Field-Based

Transferred to this area where I held a short stint in providing clinical pharmacology expertise to process review and optimisation strategy. Maintained oversight of global projects ensuring all aspects of quality and quality management were evaluated in an ongoing manner.

Field-Based

Promoted to Senior Specialist in January 2019. Key aspects of the role include:* Responsibility for the continued development and optimisation of global clinical pharmacology operations processes, including SOP updates, training and mentoring* Internal ‘Process Consultant’ for all Clinical Pharmacology Study Managers – advising and mentoring across all aspects of study set-up, conduct and close down* Independently evaluate operational processes, meetings, documentation and SOP execution across clinical pharmacology studies with the aim to ensure correct and consistent application of these across studies * Evaluation of new and established global clinical sites for early phase studies in particular those with complex requirements * Review key documents and approve IMP-release to clinical sites and to permit the initiation of screening activities* Involvement in cross-departmental groups including Vendor Co-ordination, Pharmacovigilance, MRCQA, and other working groups such as Protocol Deviation Process etc* Audit Anchor and Audit Moderator – participate and support internal and external audits, and act as CAPA Moderator where necessary

Field-Based

Extensions beyond the role of Senior Clinical Pharmacology Study Manager (below) include: * Responsibility for providing operational expertise and input to study designs * Management of multiple global clinical pharmacology studies of varying complexity in several compound/disease indications in both healthy volunteers and patients* Management of studies in Europe, US and Asia-Pacific demonstrating a high level of understanding of country-specific regulations and guidelines * Representing Clinical and Quantitative Pharmacology in Clinical Satellite Teams* Provide input to process optimisation strategies and SOPs* Provide training and mentoring to staff within the Clinical and Quantitative Pharmacology Department in areas of expertise as an operational expert

Field-Based

* Management of first-in-human studies; also PET ligand validation, PET, MRI, EEG, Driving Performance, Radiolabelled, cognition, food interaction, bioeqivalence studies in isolation and in combination* Study Management responsibilities - Kick-off Meetings with Lundbeck Study Management Team - defining study timelines / deliverables / actions* Facilitation of international CA and EC submissions* Site (CRO or University Department) assessment, study set-up, initiation and management in UK and mainland Europe not limited to but including Denmark, the Netherlands, France, Sweden and Germany* Generation of Work Orders for all sub-contracted CROs/service providers * Training, mentoring and management of CRAs and study-specific monitoring July 2013 - Promoted to Senior Clinical Pharmacology Study ManagerJuly 2009 - Promoted to Senior Clinical Pharmacology Research Associate (Specialist Sr. Phase I CRA)Jan 2007 - Clinical Pharmacology Research Associate (Specialist Phase I CRA)

Uk, Field-Based

* UK/Ireland Lead-CRA for a Global (140 site) Phase II study in Rheumatoid Arthritis* Site Evaluation, Feasibility and Recruitment Motivation visits with hospital sites* Performed Study Start-up and Initiation Meetings with Consultant Investigator/other site staff* Monitoring: 100% CRF SDV, IMP etc.* UK/Ireland CRA representative in European-level project meetings * UK CRA for Global Phase III Osteoarthritis study (110 patients)* Monitoring: including X-ray/DEXA

Promoted to Senior Project Manager in March 2000. Collective experience includes:* Team Leader, Project Management: line-management of a Senior and Trainee Project Manager; conducted on-going status meetings and appraisals; managed workload and study allocation to 6 Project Managers * Assessment of study proposals for feasibility* Co-interviewing for appointment of Project Managers* Managed EC schedule for all Phase I studies conducted at the clinic* Japanese Sponsors: expert in the management of Japanese sponsors; visited Japan with Medical Director* Delivered Annual Protocol Development Lecture to Pharmacology undergraduate students, Leeds University * Leading CRO Project Team during the set-up/execution and assistend during the reporting phases of studies* Identified and worked with appropriate specialists for input to complex Phase I studies (e.g. CDR, CogState, Ophthalmologist, Urologist, Cardiologist, Neurologist, Psychologist and Nutrition experts)* Study design experience (gained at Covance) includes: single, multiple, combined single and multiple-dose studies; first-in-human, drug-drug interaction, radiolabelled, micro-radiolabelled, opiate, QTc, bioavailability, bio-equivalence, in- and ex-vivo pharmacodynamic studies * Dose administration route experience includes: all oral forms, intravenous, subcutaneous, intra-dermal, topical and inhalation* Clinical study protocol and volunteer information/consent form development and authorship* Organised, chaired and minuted study set-up and close-down meetings* Maintained an awareness of any potential impact on study budget during study conduct* Scientific review of draft study report* Study Closedown Meetings: ensured study documentation was filed and archived in accordance with Sponsor/Covance SOPs and GCP

Leeds, United Kingdom

* Organised practical clinical conduct of Phase II – IV clinical trials (acne, psoriasis, eczema, androgenic alopecia)* Patient recruitment - performed pre-screening interviews* Trained acne lesion assessor (Leeds Technique): involved clinical assessment of patients participating in clinical trials* Performed clinical functions: vital signs measurements, blood collection/processing, sample shipment* Expert in the measurement of Sebum Excretion Rate (SER). Trained overseas medical/scientific staff in the technique* Identified psoriatic plaque active edges using lazer-doppler flowmetry* Worked in collaboration with a pioneering Facio-Maxillary Plastic Surgeon for the assessed a unisex cosmetic camouflage for the concealment of acne-induced scarring

Bsc (Hons), Biochemistry & Biology

Msc (Science), (Medicinal Chemistry; Medical Imaging; Dementia And Psychosis), (Merit)