Programme Manager - Translational and Clinical Research Job description and particulars of office Molecular Medicine Ireland (MMI) (www.molecularmedicineireland.ie) is a charitable company established by five leading Irish academic institutions (NUI Galway, RCSI, TCD, UCC and UCD) to promote their shared interest in translational and clinical research and postgraduate education. The vision of MMI is improved healthcare through the development of diagnostics and therapies from concept to realisation. The mission of MMI is to mobilise the strengths of the five partner institutions and their associated hospitals to build a sustainable national system to coordinate, support and promote translational and clinical research to achieve its vision. MMI is funded under the Programme for Research in Third Level Institutions to coordinate doctoral programmes across its partner institutions and to organise courses and workshops in translational research. MMI is responsible for developing the Irish Clinical Research Infrastructure Network (www.icrin.ie) and is the Irish scientific partner of the European Clinical Research Infrastructure Network ( www.ecrin.org) and the European Biobanking and Biomolecular Resources Infrastructure (www.BBMRI.org) with funding from the Health Research Board (HRB), Enterprise Ireland (EI) and the European Union. MMI is coordinating the deployment of the Dublin Centre for Clinical Research, funded by the Wellcome Trust and the HRB. In support of its mission, MMI has developed an on-line web technology platform web-portal and a bioresource web library. MMI wishes to appoint a Programme Manager - Translational and Clinical Research to align, manage and lead the delivery of its translational and clinical research programmes. Reporting Relationships The Programme manager - Translational and Clinical Research will report to the Chief Executive. The Programme Manager will be supported by a team of three or four people. Role The role of the Programme Manager -Translational and Clinical Research is to facilitate clinical investigators conduct multi-centred clinical studies at national and European level, to position ICRIN as the national coordinating body for clinical research in Ireland and to build capacity for translational research through collaborative initiatives in relation to biomarker discovery and validation, research technologies, biobanking and other relevant activities. In addition to his or her responsibility for directly managed resources, the Programme Manager will be expected to work with clinical and translational personnel in the MMI partner institutions to maximise the return from the commitment to collaboration represented by MMI. 1 Responsibilities The responsibilities of Programme manager - Translational and Clinical Research are as follows: Strategic and Stakeholder Management Support the ICRIN Working Group and the ICRIN Clinical Director to address priority issues in clinical research, including process and systems harmonisation, streamlining regulatory and other approval processes and cost harmonisation for core trial services. Lead the preparation of the business case for the development of ICRIN as the nationally and internationally recognised trans-disease coordinating centre to facilitate the conduct of multicentre clinical research and clinical trials by academic and industry investigators. Work with MMI partners and other interested parties to support the Irish Biomarker Network to address key issues in facilitating biomarker clinical validation and translation to the clinic. Work with the MMI partner institutions to identify new strategic opportunities for translational and clinical research collaborations. Work with the IDA, Enterprise Ireland and representatives of pharma, diagnostic and bio-tech industry to facilitate linkages between researchers, clinicians and industry. Make the case to national and international funding and state bodies for targeted funding and strategic investment in areas of translational and clinical research to add value to Ireland’s reputation in translational and clinical research. Contribute to the development of policy by responding to public consultations pertaining to translational and clinical research, participating in government convened panels in research and life sciences, liaising with patient organisations and other key stakeholders to establish clinical research as part of the continuum of clinical care. Oversee MMI/ICRIN’s participation and commitment to ECRIN and BBMRI as the scientific partner for both European research infrastructures. Represent and promote MMI at national, all-island and international level in relation to translational and clinical research. Identify funding opportunities at national, all-island and international level for collaborative initiatives in research and facilities which would assist MMI promote translational and clinical research. Contribute to the preparation and implementation of the MMI strategy 2012-2014 and the annual business plan Operational Management Manage the delivery of the ICRIN Work Plan, including agreed outputs in clinical research readiness and governance and process and training as agreed with the HRB. Mange the delivery of the translational research work programme. 2 Develop and ensure delivery of education and training programmes for clinical research personnel that allow standards to be updated and constantly improved, in close association with the Programme Manager – Education and Training. Manage the contract with Enterprise Ireland to increase the number of clinical trials of new products in Ireland and ensure commitments are delivered. Manage relationships with the funding and state agencies and HSE with regard to the clinical and translational research programme. Prepare high quality reports on the translational and clinical Research programme for the CEO, the Board, funders and the partner institutions. Manage the development of the MMI website as a key source of information on clinical and translational research in Ireland and input to the annual reports and newsletters. Financial Management Manage the budget for translational and clinical activities, in close association with the Finance and Operations Manager Prepare funding applications for collaborative translational and clinical research programmes coordinated by MMI, in association with researchers in partner institutions and contribute to collaborative proposals for translational and clinical research led by MMI partners. People and Team Management Manage the staff assigned to the translational and clinical research programme and ensure that each member has clear objectives and performance standards. Facilitate the development and training of staff in accordance with MMI policy. Contribute as a member of the MMI operational management group to the effective working of the organisation and its corporate development. The appointee will undertake such other reasonable and lawful duties as may be directed from time to time by the Chief Executive. Qualifications and Requirements: A post graduate qualification in an area of clinical / biomedical sciences with a desired preference for expertise in the delivery of early phase clinical research (in particular in experimental medicine, Phase I clinical trials, biomarker discovery and clinical validation). Comprehensive clinical trial expertise in the design and delivery of trials - early or late phase. Thorough knowledge of the regulatory approval processes for pharmaceuticals, diagnostics and devices in Europe and the US. A comprehensive understanding of the translational research environment and relevant policies, in particular in the areas of early phase research in pharmaceuticals, biologics and/or biomarkers. A good understanding of the translational research landscape and underpinning resources in Ireland. Experience of building collaborative programmes at a leadership level. 3 Extensive experience in the planning, management and delivery of translational and clinical research projects / programmes Experience of preparing policy documents and influencing national clinical and translational research priorities. Good IT skills and understanding of website communications. An applicant must be an EU citizen or be from outside the EU with permanent Irish resident status or a valid work permit. Competencies: The competencies required for the post include the ability at a high level to: Develop and lead by vision and values, with a strong customer focus. Develop and contribute to strategic development and planning to enable clinical and translational research. Plan, develop and manage the translational and clinical research programme. Network and influence in a collaborative environment. Set standards of performance for staff and ensure quality processes and value for money. Work harmoniously and effectively in a multi-disciplinary environment Communicate the vision, mission and values of Molecular Medicine Ireland. Communicate effectively at an interpersonal level and in written and oral presentations. The successful candidate will be: A highly motivated person with a high level of personal and professional integrity Personally effective and creative. Particulars of Office The post of Programme manager - Translational and Clinical Research is offered on a contract for two years initially. An attractive remuneration package of up to €80,000 will be offered to the successful candidate. The successful candidate will be expected to work in the office of MMI which is currently located in Dublin city centre. Application Process Persons interested in this post should send a covering letter and CV to info@MolecularMedicineIreland.ie. Applications are invited before Friday 21 January 2011. Shortlisted candidates will be invited for interview. MMI is an equal opportunities employer. 4