CONSULTANT PHARMACIST, CLINICAL TRIALS & EXPERIMENTAL CANCER MEDICINES

This innovative new post is a critical part of the multidisciplinary team that will support The Christie Research 2030 programme, a transformational investment in cancer research over the next 6 years. Our ambition of research-embedded healthcare will deliver better outcomes and reduce health inequalities for all patients. We plan to learn from every patient and enable every patient to take part in research. Aligned to The Christie Strategy we will realise the potential of The Paterson Research Building, home to one of the largest concentrations of scientists, doctors and nurses in Europe to bring tomorrow's treatments to patients faster and enable Christie leaders to drive seamless integration of research with clinical care. The diverse needs of 30,000 new patients annually will be met through an inclusive, learning healthcare system spanning next generation diagnostics, treatments, digital and real-world evidence research. We intend to double and then treble the number of patients participating in research, bringing innovations for better outcomes to The Christie.

Main duties of the job

The postholder will lead a high-quality professional pharmacy Clinical Trials service, optimising patient access to and outcomes from clinical trials, improving the overall patient experience.

The postholder will ensure that pharmacy clinical trials services are provided in a safe, efficient manner, compliant with all relevant UK and EU legislation and professional regulations and fully aligned with the Trust's research strategy and the pharmacy service strategy.

The postholder will lead, develop and be responsible for pharmacy clinical trials and experimental cancer medicines services across the Trust and the wider Cancer Network, deputise for the Director of Pharmacy at the Trust R& I Divisional and Christie Research Executive Committee meetings, providing regular updates on pharmacy services, performance metrics and on developments with clinical trials and experimental cancer medicines.

In addition to the clinical trials workload, the postholder will provide leadership for Pharmacy's own rapidly-growing portfolio of practice research and service developments.

About us

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world chemotherapy on site and through 14 other hospitals highly specialist surgery for complex and rare cancer and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

Key responsibilities

To lead a high-quality professional pharmacy Clinical Trials service, optimising patient access to and outcomes from clinical trials, improving the overall patient experience

To strategically lead and co-ordinate the Clinical Trials pharmacy team in the provision of a safe, effective and efficient service in accordance with local and national standards and strategy

To contribute to improving health outcomes for patients using a holistic approach to care, ensuring the safe and effective use of medicine through provision of medicines-related aspects of patient care To ensure pharmacy clinical trials services are provided in a safe, efficient manner and are compliant with all relevant UK and EU legislation and professional regulations.

To ensure that pharmacy clinical trials services are fully aligned to support the Trusts research strategy and the pharmacy service strategy.

To lead Pharmacy support at MHRA GCP inspections ensuring access to documentation

To provide with expert advice to the national Clinical Trials pharmacy advisory group, Trusts R& I Division and Clinical Trials Principal Investigators in respect of all aspects of IMP manufacture, procurement and supply

Provide professional leadership to clinical trials pharmacy staff and manage the lead pharmacists, ensuring compliance with regulations and standards.

To lead, develop and be responsible for pharmacy clinical trials and experimental cancer medicines services across the Trust and the wider Cancer Network

Deputise for the Director of Pharmacy at the Trust R& I Divisional and Christie Research Executive Committee meetings, providing regular updates on pharmacy services, performance metrics and on developments with clinical trials and experimental cancer medicines

To provide professional leadership for pharmacy Clinical Trials services to assure the Trust of compliance with the Human Medicines Regulations 2012 SI No.1916 and the applicable SI including: Medicines for Human Use (clinical trials) Regulations 2004 and subsequent amendments The Medicines for Human Use (Clinical Trials) and blood safety and quality (Amendment) Regulations 2008, SI No.941 EU Directive 2001/20EC, International Convention of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP)

Updates and advises the Director of Pharmacy and wider pharmacy senior management team on pharmacy clinical trial services and experimental cancer medicines providing assurance on compliance with legislation, capacity and capability.

Act as the pharmacy expert on Advanced Therapy Medicinal Products used in clinical trials, contributing to their safe and efficient handling within the Trust and compliance with regulation and guidance.

To use innovation to support effective patient outcomes, safety and experience aligned with relevant national agenda.

To lead, undertake, supervise and publish research in specialist area of practice.

In line with the National Profiles for Pharmacy, produced by NHS Employers, the consultant pharmacist post requires the postholder to:

a. Be responsible for leading and delivering highly specialist pharmacy service undertake relevant risk management and ensure compliance with medicines legislation

b. Provide expert advice on pharmaceutical matters in specialist field

c. Lead and develops clinical audit co-ordinate and undertake research provide specialist training

Statutory Professional Responsibilities

Practice within the professional boundaries described by the General Pharmaceutical Council.

Undertake annual professional revalidation comprising continuing professional development (CPD) entries, reflective account and peer discussion.

Follow legal, ethical, professional and employers codes of conduct.

Undertake formal GCP and GMP training and maintain competency.

To contribute to local, regional and national training initiatives for clinical trials and experimental cancer medicines.

Expert professional practice

To be recognised as an expert within the speciality of clinical trials pharmacy, locally and nationally and/or internationally

Provide senior level expert advice to the Trust Research & Innovation Division, Chief Investigators & the Trust on Investigational Medicinal Products (IMPs) and take responsibility for their procurement, storage and handling on site.

Act as the main pharmacy link to research stakeholder groups including the Experimental Cancer Medicines Team, the University of Manchester and the Manchester Cancer Research Centre

Oversee pharmacy governance arrangements for clinical trials and experimental cancer medicines, ensuring they are of appropriate quality for their intended use and introduced safely.

Lead expert pharmacy support including the development of trust policy, protocols and SOPs on clinical trials

Compliance with legislation and guidance

Technical and regulatory assessment and advice

Ensure that staff handling clinical trials medication have the appropriate skills and expertise

Ensure robust links with specialist disease group and aseptic service pharmacy teams

Be responsible for Pharmacy working practices to assure the Trust of compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (EU Directive 2001/20EC), International Convention of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).

Provide advice to all trust research stakeholders in respect of all aspects of CTiMP manufacture, procurement and use and of adherence to associated legislation.

To maintain a comprehensive knowledge of national regulations and directives, legislation and recommendations from the Department of Health, the European Medicines Agency (EMA), the MHRA, NHS England and the General Pharmaceutical Council and Royal Pharmaceutical Society relating to CTiMPs, ATMPs and GCP. To be responsible for the impact of changes to these standards and implementing change where required.

Provide expert and management support for MHRA GCP inspections, other national regulatory bodies and sponsor inspections, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings.

Ensure that clinical trials and advanced therapy medicinal products services are integrated into the pharmacy clinical governance agenda and play a lead role in the agenda and work of the Pharmacy governance programme

To appropriately manage difficult and ambiguous problems, managing uncertainty, and to make decisions with limited information.

Please refer to the attached job description for further job description and main responsibilities.

Prepare long-term plans for a phased replacement of, and addition to major capital assets within the clinical trials and experimental cancer medicines pharmacy service

Person Specification

Qualifications

Essential

• Masters Degree in Pharmacy or equivalent
• Pharmacist registration with the General Pharmaceutical Council
• Postgraduate diploma in clinical pharmacy or equivalent
• Independent Prescriber or working towards this with a view to qualification within 12 months (or willingness to work towards this)
• Meet the requirements of the RPS Faculty cancer care expert professional practice curriculum
• Member of the Royal Pharmaceutical Society (RPS)
• Membership of the British Oncology Pharmacy Association
• Demonstrated ability to work at Doctorate level
• Credentialed as a consultant pharmacist with the RPSGB (or consultant-ready awaiting appointment to an approved post) is an essential requirement for appointment at Consultant status. NB: Should an appointment be made to an individual still working towards consultant level, the postholder may only use the title Consultant Pharmacist once RPSGB credentialing has been successfully achieved.
• A majority of competencies in each of the expert professional practice, collaborative working relationships and leadership clusters at the highest level (mastery) as defined in the Royal Pharmaceutical Society Advanced Pharmacy Framework (APF)
• A majority of the competencies in each of the management, education, training and development and research and evaluation clusters at the Advanced Stage II as defined in the Royal Pharmaceutical Society Advanced Pharmacy Framework (APF)

Desirable

• Post Graduate qualification in Clinical Oncology, HaemOnc, or Clinical Research
• Management, leadership or quality improvement training
• DPharm, PhD or undertaking study at doctorate level

Expert Professional Practice

Essential

• Extensive clinical pharmacy experience within Cancer services
• Evidence of ability to plan complex pharmaceutical care programmes for patients
• Experience in the management of pharmacy clinical trials, including GCP
• Demonstrates application of critical evaluation skills in the context of working practice
• Able to demonstrate ability to apply research and evidence-based practice within the team and/or service
• Able to demonstrate ability to make decisions in the absence of evidence or data or when there is conflicting evidence or data.
• Demonstrates accountability for the delivery of professional expertise at a defined higher level.
• Ability to work in a pressured environment, with an unpredictable workload
• Demonstrates awareness of and commitment to the clinical governance agenda
• Understanding of health economics
• Expert IT skills

Desirable

• Experience of using chemotherapy e-prescribing systems (iQemo, Chemocare or equivalent)

Collaborative Working Relationships

Essential

• Excellent verbal and written communication skills
• Experience of working successfully with a range of stakeholders outside NHS structure eg. industry, service users, Higher Education institutions.
• Ability to analyse, interpret and communicate highly complex clinical and technical information in an informative manner to a wide range of individuals which may be in challenging circumstances
• Demonstrable high level understanding of current issues on cancer services and clinical trials
• Team player but also able to work autonomously

Desirable

• Experience of work at national level (development of policies, strategies, national guidelines etc)

Leadership

Essential

• Highly developed leadership skills
• Experience of leadership skills in highly complex projects and change management skills
• Proven experience of working at a strategic level across healthcare geographies and the wider health community
• Demonstrable experience of change management at a senior pharmacy level
• Excellent interpersonal, negotiating and influencing skills. Able to convince others to share the vision at a higher level.
• Ability to engage, motivate and lead a wide range of professionals
• Inspires confidence and positive role model
• Demonstrates values
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