Experience

Boyds

• United Kingdom
• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Mar 2020 - Present

  Provision of EU and FDA strategic regulatory advise and support across a range of therapeutic areas and all development stages for ATMP and other biological and chemical products. Operational support for activities described above. Provision of EU and FDA strategic regulatory advise and support across a range of therapeutic areas and all development stages for ATMP and other biological and chemical products. Operational support for activities described above.



Cancer Research UK & UCL Cancer Trials Centre

• United Kingdom
• Research
• 1 - 100 Employee

• Trial Group Lead - Advanced therapies

  • May 2016 - Mar 2020

  Managing team and trials portfolio specialising in gene therapy and somatic cell therapy trials. • Leading on contractual negotiations on behalf of UCL with partners such as vector or ATIMP manufacturers, trial sites, central labs, courier companies, CROs, pharmaceutical companies. • Delivering high quality applications to REC and Competent authorities. Initiating and managing appropriate responses to their review issues within assigned timelines. • Ensuring reports to external bodies… Show more Managing team and trials portfolio specialising in gene therapy and somatic cell therapy trials. • Leading on contractual negotiations on behalf of UCL with partners such as vector or ATIMP manufacturers, trial sites, central labs, courier companies, CROs, pharmaceutical companies. • Delivering high quality applications to REC and Competent authorities. Initiating and managing appropriate responses to their review issues within assigned timelines. • Ensuring reports to external bodies (Funders, MHRA, GTAC) or internal committees (UCL Sponsor Oversight Committee, TMG or IDMC) are completed and submitted within stipulated deadlines. • Submitting and discussing regulatory or scientific questions with regulators (MHRA, GTAC, HTA, HSE, HRA). • Creating budgets • Appointing IDMC and TMG, participating in TMG and IDMC meetings, ensuring their recommendations are disseminated and acted upon in a timely manner. • Writing /reviewing trial protocols, Investigator’s Brochures (IB), Investigational Medicinal Product Dossiers (IMPDs), patient orientated documents or any other trial related documents in collaboration with trial teams. • Providing training in GCP and ATIMP regulatory and governance requirements; this includes: - Teaching new and existing staff at CTC or other UCL affiliated trial centres - Teaching on UCL BSc and MSc courses - Arranging meetings and speakers, or presenting at ‘UCL ATIMP Forum’ meetings, where staff working with ATIMPs from UCL and its partner institutions are invited (e.g. trial coordinating staff, manufacturing staff, cell-therapy laboratory staff, pharmacists, monitors, research nurses, data managers). The aim of this Forum is to train staff on relevant topics, give regulatory updates and to provide a platform where issues can be discussed in a multidisciplinary arena. • Line management, which includes evaluating staff performance through ongoing monitoring, probation reviews and regular appraisal Show less Managing team and trials portfolio specialising in gene therapy and somatic cell therapy trials. • Leading on contractual negotiations on behalf of UCL with partners such as vector or ATIMP manufacturers, trial sites, central labs, courier companies, CROs, pharmaceutical companies. • Delivering high quality applications to REC and Competent authorities. Initiating and managing appropriate responses to their review issues within assigned timelines. • Ensuring reports to external bodies… Show more Managing team and trials portfolio specialising in gene therapy and somatic cell therapy trials. • Leading on contractual negotiations on behalf of UCL with partners such as vector or ATIMP manufacturers, trial sites, central labs, courier companies, CROs, pharmaceutical companies. • Delivering high quality applications to REC and Competent authorities. Initiating and managing appropriate responses to their review issues within assigned timelines. • Ensuring reports to external bodies (Funders, MHRA, GTAC) or internal committees (UCL Sponsor Oversight Committee, TMG or IDMC) are completed and submitted within stipulated deadlines. • Submitting and discussing regulatory or scientific questions with regulators (MHRA, GTAC, HTA, HSE, HRA). • Creating budgets • Appointing IDMC and TMG, participating in TMG and IDMC meetings, ensuring their recommendations are disseminated and acted upon in a timely manner. • Writing /reviewing trial protocols, Investigator’s Brochures (IB), Investigational Medicinal Product Dossiers (IMPDs), patient orientated documents or any other trial related documents in collaboration with trial teams. • Providing training in GCP and ATIMP regulatory and governance requirements; this includes: - Teaching new and existing staff at CTC or other UCL affiliated trial centres - Teaching on UCL BSc and MSc courses - Arranging meetings and speakers, or presenting at ‘UCL ATIMP Forum’ meetings, where staff working with ATIMPs from UCL and its partner institutions are invited (e.g. trial coordinating staff, manufacturing staff, cell-therapy laboratory staff, pharmacists, monitors, research nurses, data managers). The aim of this Forum is to train staff on relevant topics, give regulatory updates and to provide a platform where issues can be discussed in a multidisciplinary arena. • Line management, which includes evaluating staff performance through ongoing monitoring, probation reviews and regular appraisal Show less



University Collgege London

• Advanced Therapies Regulatory Manager

  • Mar 2010 - Apr 2016

  Setting up and overseeing management of Clinical Trials with gene therapy, cell therapy or tissue engineered medicinal products. Ensuring that Advanced Therapy trials conducted by UCL are managed in accordance with current legal and regulatory requirements. Costing clinical trials and assisting in grant applications. Setting up and overseeing management of Clinical Trials with gene therapy, cell therapy or tissue engineered medicinal products. Ensuring that Advanced Therapy trials conducted by UCL are managed in accordance with current legal and regulatory requirements. Costing clinical trials and assisting in grant applications.



European Forum for Good Clinical Practice (EFGCP)

• Board Member

  • Jan 2013 - Jan 2016

  The European Forum for Good Clinical Practice (EFGCP) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe. http://www.efgcp.be The European Forum for Good Clinical Practice (EFGCP) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe. http://www.efgcp.be



King's College London

• United Kingdom
• Research Services
• 700 & Above Employee

• Ethics Committee Member

  • Jul 2008 - Jul 2010

  member of the Biomedical & Health Sciences, Dentistry, Medicine and Physical Sciences & Engineering Research Ethics Subcommittee (BDM RESC) member of the Biomedical & Health Sciences, Dentistry, Medicine and Physical Sciences & Engineering Research Ethics Subcommittee (BDM RESC)



EBMT (European Group for Blood and Marrow Transplantation)

• Clinical Trials Operations Manager

  • Jan 2000 - Feb 2010

  Setting up and managing international clinical trials, mainly in haematology and oncology. Regulatory lead for organisation. Finance manager for trials portfolio. Setting up and managing international clinical trials, mainly in haematology and oncology. Regulatory lead for organisation. Finance manager for trials portfolio.



Department of Haematology, University of Cambridge

• Research Assistant

  • Mar 1995 - Dec 1999