Role Profile
Clinical Oncology Advisor, Clinical Assessment –
Human Products Authorisation and Registration
ROLE SUMMARY
The Clinical Oncology Advisor assignment will be to the Human Products Authorisation and
Registration (HPAR) department (assessment and licensing activities).
Reporting to the Clinical Assessment Manager, the role of the Clinical Oncology Advisor is to:
lead the evaluation and regulation of the safety and efficacy of medicinal products (medicines)
which have oncology and haematological oncology indications in Ireland and the European
Union; lead in the provision of technical support to the Clinical Assessment Managers, the
Director of HPAR, and other areas of the organisation on relevant issues relating to the safety
and efficacy of oncology and haematological oncology medicines in order to facilitate their
efficient licensing; assist in the strategic development of the organisation with respect to
increasing its profile and recognition within Europe in the assessment of medicines for
oncological indications.
The following key activities are indicative of the range of duties to be undertaken by the Clinical
Oncology Advisor:
o Leading the scientific evaluation of the safety & efficacy of medicines with oncology and
haematological oncology indications which are the subject of new applications; analysis of
their benefit/risk profiles; reporting and forming conclusions in respect of their suitability
for use as medicines as well as consideration of the public health consequences of their
use.
o Reviewing the on-going safety and efficacy of authorised medicines with oncology and
haematological oncology indications; analysis of their benefit/risk profiles; reporting and
forming conclusions in respect of their suitability for use as medicines as well as
consideration of the public health consequences of their use.
o Leading the assessment of applications for clinical trials involving medicines with
oncology and haematological oncology indications. Coordination of the assessment of
such clinical trials including required liaison with external experts.
o Leading on the clinical assessment of applications for European Scientific Advice relating
to medicines with oncology and haematological oncology indications.
o Leading on all clinical aspects relating to the strategic development of the organisation in
increasing its profile in the assessment of oncology medicines at national and European
levels.
o Assisting in the development of the HPRA’s strategic approach to the assessment of
biosimilar and biological medicines; liaison and coordination of work with colleagues in
clinical, non-clinical and pharmacy assessment in order to achieve this objective; assisting
in the development of internal training programmes required to support this objective.
o Developing the organisation’s network of experts in the areas of oncology and
haematological oncology.
o Establishing an internal mentoring and training programme on the clinical assessment of
oncology medicines.
o Coordination of assessment resources to ensure maximum productivity by: defining
objectives, setting targets, coordinating activities, agreeing priorities, developing team
members, maintaining effective communication lines and ensuring that the required
standards, policies and practices are in place for the clinical assessment and scientific
evaluation of applications received.
o Assessment of medical devices used in oncological indications.
o Providing leadership, motivation, encouragement and effective management for
reporting staff; maintenance of a positive working environment and relationships.
o Provision of technical information, advice, and guidance to HPRA colleagues, relevant
bodies and individuals.
o Representing the HPRA on national, European and international platforms. Participation at
all levels (HPRA, national and international) in the formulation and preparation of
regulatory policies, guidelines, legislation and opinions.
KEY RESPONSIBILITIES
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Strategic Management
o In conjunction with the HPAR Director and Clinical Assessment Manager(s) leading in the
development of the HPRA’s strategy with respect to the clinical assessment of medicines
for oncological indications
o Supporting the Clinical Assessment Managers in the on-going development of the
clinical/non-clinical assessment team
o Working with the Clinical Assessment Managers and Senior Clinical Assessors to prioritise
objectives and to ensure that the strategic and operational goals of the clinical
assessment team are achieved
o Providing leadership, support and direction to the clinical assessment team as appropriate
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Technical/Operational Objectives
o Assessment of safety and efficacy data submitted in support of applications for marketing
authorisation, variations or renewal or authorisations for human medicines with oncology
and haematological oncology indications, in accordance with the following procedures:
o national
o mutual recognition
o decentralised
o centralised
o Technical assessment of safety and efficacy data submitted in support of applications to
conduct clinical trials in respect of human medicines (containing new chemical entities or
established active ingredients). The primary area of focus will include medicines indicated
for oncology and haematological oncology indications
o In conjunction with the Clinical Assessment Managers co-ordination of the clinical
assessment activities relating to applications for medicines authorisations and clinical
trials for oncology and haematological oncology medicines. This includes as appropriate:
planning and managing bidding strategies; planning, managing and organising the
allocation of resources and assessment activities; planning, organising and managing the
required coordination with external experts
o All of the assessment responsibilities outlined above may be extended to include clinical
assessment of medicines across a range of indications, as HPRA business needs require
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o Assessment of applications for clinical investigations of medical devices or applications to
use medical devices in oncology and haematological oncology indications
o Analysis, in the context of public health, of benefit/risk profiles of applications for
marketing authorisation; making recommendations and preparation and presentation of
reports to the Board, Advisory Committees and Sub-Committees or the Management
Committee of the HPRA, and/or the European Medicines Agency (EMA), or its
representative working parties, regarding the suitability of oncology and haematological
oncology medicines for marketing approval
o Assisting in the compilation of data and preparation of management reports as required
o Technical liaison with, and advice to, applicants and professional colleagues in order to
facilitate the assessment process
o Providing technical information, advice and guidance to organisations, {such as the
Department of Health (DoH), the Irish Blood Transfusion Service (IBTS), the Food Safety
Authority of Ireland (FSAI), industry representative bodies etc.}, to healthcare professionals
and lay persons
o Ensuring knowledge of state-of-the-art technologies through ongoing professional
education and review of the published literature
o Providing advice and professional expertise to the HPRA's inspectors in the performance
of their duties
o Participation in the enforcement of regulations governing medicines and medical devices
o Participating in the management of assessors in the execution of their professional duties
in such a manner as to contribute to the efficiency and effectiveness of the HPAR
department
o Providing training, mentoring and technical support to assessors and other members of
staff as needed.
o Managing and developing members of the clinical/non-clinical assessment team as may
be required to meet evolving business needs
o As may be required, deputising for the Clinical Assessment Manager(s)
o Promoting a positive, open, friendly and professional working environment
o Attending internal HPRA meetings as appropriate
o Other such duties whether connected with or incidental to the functions of the HPRA or
not, as the HPRA may reasonably require
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Quality Management
o Assisting the Clinical Assessment Managers to ensure the effective implementation of the
HPRA quality management system
o Assisting the Clinical Assessment Managers to ensure that there are effective mechanisms
in place to capture, store and communicate key information, experience and knowledge
o Assisting the Clinical Assessment Managers to ensure that available information and
knowledge across the HPRA is effectively used by the section
o Assisting the Clinical Assessment Managers to ensure that section procedures remain up to
date with relevant developments in National, European and International regulations,
legislation and guides
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Performance Management
o Working with the Clinical Assessment Managers to promote effective performance within the
Human Products Authorisation and Registration department
o Communicating goals, objectives and targets as appropriate
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o Participating in the performance development programme (PDP) and as appropriate
managing reporting staff through the programme
o Taking measures to identify and resolve issues impacting performance in the team
o Reporting regularly on progress against specified objectives, goals and performance
targets
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Coaching and Development
o Ensuring in conjunction with the Clinical Assessment Managers and Senior Medical
Officers that staff within the clinical/non-clinical assessment team receive appropriate
training in the areas of oncology and haematological oncology
o Coordinating the planning and delivery of training for the clinical assessment team,
including liaison with other colleagues as required
o As appropriate provision of training and support in the areas of oncology and related
areas to colleagues within other departments within HPRA including HPM and
Compliance.
o Providing performance feedback, coaching and mentoring support to staff in the clinical
assessment team as may be appropriate to the role
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Communications/Customer Service
o Participation in regular human medicines departmental meetings and HPRA meetings
o Attendance at meetings and symposia at home and abroad and representing the HPRA as
appropriate
o Representing the HPRA as appropriate at national and international meetings/working
groups, especially those associated with the European Medicines Agency (EMEA)
o Conducting technical liaison with applicants, regulatory authorities, healthcare
professionals and other relevant stakeholders
o Provision of technical information, advice, and guidance to regulatory authorities,
healthcare professionals and other relevant stakeholders
o Working with colleagues in the HPAR department to maintain positive relationships with
stakeholders that reflects the professionalism and high standards of the HPRA in the
conduct of medicines assessment and related activities
o Liaising with officers of the State, other bodies, and industry sections, as appropriate, on
human medicines issues
o Providing timely input to the HPRA’s newsletter and HPRA web-site as necessary
o Execute professional duties in such a manner so as to contribute to the efficiency and
effectiveness of the HPRA
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General
o Perform such other duties as the HPRA may reasonably require
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QUALIFICATIONS AND EXPERIENCE
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To be considered for this post, candidates must:
o be registered with the Medical Council in Ireland
o be a registered medical practitioner with a minimum of three years satisfactory service in
clinical practice (after becoming entitled to full registration)
o clinical training in oncology and/or haematological oncology and relevant experience of
clinical practice in this area
o detailed knowledge and experience of managing EU authorisation procedures for
medicines
o experience in the management of a multi-disciplinary team
o have excellent interpersonal and communication skills
o be of good character
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In addition to this the ideal candidate will also have one or more of the following;
o have an additional undergraduate or postgraduate qualification in a relevant scientific
discipline
o published research in the academic, clinical or industrial field of medicine
o evaluation of medicines in the industrial, government authority, academic or clinical
situation
o good understanding of methodology and biostatistics in pharmaceutical medicine
o good understanding of pharmacokinetics and pharmacodynamics and processes for
assessment of biological and biosimilar medicines
o knowledge or experience of the use and management of medical devices
REMUNERATION
Salary:
€86,551 per annum (*new entrants - incremental scale).
SUPERANNUATION
The new Single Public Service Pension Scheme (“Single Scheme”) commenced with effect from 1
January 2013. All new entrants to pensionable public service employment on or after 1 January
2013 are, in general, members of the Single Scheme.
HOURS OF DUTY
The hours of duty are fixed by the HPRA from time to time. The current arrangements are
Monday-Friday (minimum 37 hours). Appointees are eligible to participate in the flexitime
arrangements after a period of six months.
DURATION OF POST
This is a three year contract post.
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ANNUAL LEAVE
Annual leave (exclusive of usual public holidays) is 30 days per annum.
DUTIES OF POST
The duties set out in the role profile (above) are indicative of responsibilities related to this role.
As with all posts, the nature of HPRA business is evolving and flexibility is required in order to
adapt to changing business needs.
CONFIDENTIALITY AND CONFLICT OF INTEREST
Employees are prohibited from having any personal or financial interest in any industry that the
HPRA regulates from the date of appointment with the HPRA. The HPRA deals with highly
confidential matters including identifiable details pertaining to healthcare professionals, patients
and commercially sensitive information. Employees are prohibited from disclosing any
information in relation to the business of any person obtained in his/her capacity as an officer of
the HPRA.
VOLUNTARY HEALTH INSURANCE SCHEME
A group scheme operates for those wishing to participate and contributions are deducted from
salary.
REFERENCES
The names and addresses of two referees to whom the applicant is well known but not related
must be submitted with the application. Reference may be made to current and former
employers without further notification of the applicant. Applicants having any reservations on
this matter should so state at time of application.
CLOSING DATE
The closing date for applications for this post is 29th March 2015.
INTERVIEWS
Applicants attending for interview may be required to prepare a presentation-details will be
notified to applicants who are shortlisted.
It is anticipated that interviews for this post will take place in mid-late April 2015.
Note: The HPRA is not in a position to reimburse expenses incurred by candidates attending for
interview.
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COLLECTIVE AGREEMENT: REDUNDANCY PAYMENTS TO PUBLIC SERVANTS
The Department of Public Expenditure and Reform introduced, with effect from 1st June 2012, a
Collective Agreement which had been reached between the Department of Public Expenditure
and Reform and the Public Services Committee of the ICTU in relation to ex-gratia Redundancy
Payments to Public Servants. It is a condition of the Collective Agreement that persons availing
of the agreement will not be eligible for re-employment in the public service by any public
service body (as defined by the Financial Emergency Measures in the Public Interest Acts 2009 –
2011) for a period of 2 years from termination of the employment. Thereafter the consent of the
Minister for Public Expenditure and Reform will be required prior to re-employment. People who
availed of this scheme and who may be successful in this competition will have to prove their
eligibility (expiry of period of non-eligibility) and the Minister’s consent will have to be secured
prior to employment by any public service body.
DECLARATION
Applicants will be required to declare whether they have previously availed of a public service
scheme of incentivised early retirement and/or the collective agreement outlined above.
Applicants will also be required to declare any entitlements to a Public Service pension benefit
(in payment or preserved) from any other Public Service employment and/or where they have
received a payment-in-lieu in respect of service in any Public Service employment.
* Candidates should note that entry will be at the minimum of the scale and the rate of
remuneration may be adjusted from time to time in line with Government pay policy.
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