Principal Pharmacist - Oncology and Haematology Clinical Trials
Job overview
We are seeking a highly motivated, innovative and forward-thinking pharmacist to lead and develop the clinical trials pharmacy service for Oncology and Haematology Clinical Trials (OHCT) at Guy’s and St Thomas’ NHS Foundation Trust.
The post holder will provide senior professional leadership and specialist expertise to support the safe, effective and efficient delivery of a large and complex portfolio of oncology and haematology clinical trials. Working closely with OHCT, Pharmacy, R&D, KHPCTO, aseptic and technical services, and wider clinical teams, they will lead pharmacy input into the governance, development and delivery of OHCT clinical trials services.
They will help ensure compliance with relevant legislation, Good Clinical Practice, Trust requirements and pharmacy standards, and will support high-quality clinical trials pharmacy systems and processes across the portfolio. This includes leading the development, implementation and review of relevant policies, procedures and governance arrangements, and providing senior advice on medicines management in clinical trials, including investigational medicinal products, study set-up, operational feasibility, risk management and service development.
The post holder will also drive service improvement, innovation and workforce development to support a high-quality, efficient and sustainable OHCT clinical trials pharmacy service.
Main duties of the job
Lead, engage, motivate and support colleagues to deliver high-quality OHCT clinical trials pharmacy services, driving improvement in governance, quality, safety and operational practice. Lead pharmacy input into the governance, set-up, delivery and oversight of oncology and haematology clinical trials, ensuring safe, effective and efficient systems for investigational medicinal products and associated pharmacy processes.
Ensure appropriate clinical trials pharmacy governance arrangements are in place, including the development, implementation, monitoring and review of relevant policies, procedures, guidelines and protocols. Support the pharmacy review, approval, set-up and ongoing oversight of clinical trials, ensuring compliance with applicable legislation, Good Clinical Practice, Trust requirements and pharmacy standards.
Lead and support audit, monitoring, inspection readiness, incident and deviation management, and the implementation of action plans to improve quality, safety and effectiveness. Work with senior leaders and key stakeholders across OHCT, Pharmacy, R&D, KHPCTO, aseptic and technical services, and wider clinical teams.Contribute to service development, workforce planning, business planning and resource management, and lead the service in line with national strategy, regulatory requirements and the changing NHS and research environment.
Working for our organisation
Guy’s and St Thomas’ Pharmacy Clinical Governance team is part of a large, vibrant service focussing on delivery of advice related to Medicines Effectiveness and Safety. We aim to drive best practice through robust governance frameworks, collaboration and quality improvement.We promote the safe, effective and economic use of medicines in patients, through active provision and support with clinical governance processes to ensure good quality care.
Guy’s and St Thomas’ Pharmacy Department is one of the largest in the UK and has a strong focus on individual patient care. Our pharmacists work across multi-disciplinary teams both in the hospital and community setting, to deliver advice, guidance, and support within a culture of medicine safety.The focus is on patient-centred care and this is achieved through providing optimised pharmaceutical care for patients as part of a ward-based and clinical pharmacy service and extending pharmaceutical services beyond traditional boundaries.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. We also have a positive approach to corporate social responsibility and are keen to engage our staff in an agenda that ranges from promoting environmental sustainability to the creation of local employment opportunities.
Detailed job description and main responsibilities
The post holder will lead and develop the clinical trials pharmacy service for Oncology and Haematology Clinical Trials (OHCT) at Guy’s and St Thomas’ NHS Foundation Trust, supporting a large and complex portfolio of commercial and non-commercial studies, including early phase and later phase trials.
They will provide senior professional leadership and specialist expertise to ensure the safe, effective and efficient delivery of clinical trials pharmacy services across the OHCT portfolio. This will include oversight of investigational medicinal products, pharmacy input into trial feasibility, set-up and delivery, and the development of robust systems to support compliance with relevant legislation, Good Clinical Practice, Trust requirements and pharmacy standards.
The post holder will lead on the development, implementation and review of clinical trials pharmacy policies, procedures, guidelines and governance arrangements relevant to OHCT. They will support the pharmacy review, approval, set-up and ongoing oversight of clinical trials, ensuring that documentation, processes and risk controls are in place to maintain safe systems of work and audit readiness.
They will work closely with OHCT, Pharmacy, R&D, KHPCTO, aseptic and technical services, investigators and wider clinical teams to promote best practice in clinical trials pharmacy and to support consistent, high-quality service delivery. The post holder will also contribute to service development, workforce planning, business planning, resource management and the identification of opportunities for improvement and innovation.
The post holder will provide senior advice on medicines management in clinical trials, including investigational medicinal products, operational feasibility, governance, patient safety, incident and deviation management, monitoring visits, audits and inspections.They will help ensure that learning from governance processes is translated into service improvement.
The post holder will lead, motivate and support pharmacy staff and wider colleagues involved in clinical trials delivery, contributing to education, training and staff development to ensure the service remains responsive, sustainable and aligned to local, network and national priorities.
Person specification
Knowledge and Experience
Essential criteria- Extensive recent post registration hospital experience as a clinical pharmacist in a specialist area
- Significant experience in clinical trials pharmacy, ideally within oncology, haematology or another complex specialist service
- Experience of leading or developing a clinical pharmacy or clinical trials pharmacy service
- Experience of working as part of clinical and operational leadership across multidisciplinary teams
- Experience of managing staff / acting as a line manager
- Experience of working with senior healthcare professionals and wider stakeholders to deliver service improvement
- Experience of developing and implementing policies, procedures, guidelines and governance processes
- Experience of clinical governance, risk management, incident investigation and audit/inspection readiness
- Experience of supporting the set-up, review and delivery of clinical trials, including understanding of relevant legislation and Good Clinical Practice
- Understanding of quality improvement and experience of delivering service or process improvement in practice
- Experience of working with aseptic, manufacturing or technical services interfaces relevant to clinical trials pharmacy
- Experience of contributing to business planning, income/resource modelling, or cross-organisational service development
Qualifications / Education
Essential criteria- MPharm (or equivalent) degree
- Postgraduate qualifications in Clinical Pharmacy Practice (PGCert, MSc or equivalent)
- Registration with the General Pharmaceutical Council (GPhC)
- Registered with the GPhC as a non-medical prescriber
- Evidence of Good Clinical Practice (GCP) training
- Member of relevant professional groups (RPS, UKCPA)
- Relevant leadership / management qualification, or postgraduate study at Masters level
Skills and Abilities
Essential criteria- Ability to prioritise and plan work effectively, alone and for a team, including the ability to delegate
- Ability to work effectively in a complex and changing clinical, operational and research environment
- Ability to influence, negotiate and appropriately challenge practice with senior stakeholders and multidisciplinary teams
- Ability to identify, manage and monitor risk, and maintain robust governance and audit readiness
- Guidance Score Ability to prioritise and plan work effectively, independently and across teams, including the ability to delegate appropriately 2 Ability to work effectively in a complex and changing clinical, operational and research environment 2 Ability to influence, negotiate and appropriately challenge practice with senior stakeholders and multidisciplinary teams 2 Ability to identify, manage and monitor risk, and maintain robust governance and audit readiness 2 Ability to use audit, service evaluation and performance data to inform service improvement and change to practice
- Evidence of application of principles of evidence based practice and research methodology
- Able to compile and present a business case to support service / team development