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The NIHR is funded through the ___ (DHSC) and was established with the aim of creating a health and care research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public. The NIHR Research Infrastructure provides a platform to enable research by creating an environment where early stage and applied research can thrive. Our Research Infrastructure consists of research expertise, specialist facilities, a research delivery workforce and support services. The NIHR invests more than £606 million a year of infrastructure funding through a number of different five-year infrastructure funding schemes. Job Description We are looking to recruit an experienced, inquisitive and motivating manager to provide leadership to a team managing a portfolio of high profile National Institute for Health and Care Research (NIHR) experimental medicine research infrastructure funding schemes. Job Purpose The Programme Lead will provide leadership for the end-to-end grants and research management of NIHR’s experimental medicine research infrastructure portfolio, which includes the flagship Biomedical Research Centres, the Clinical Research Facilities, the Commercial Research Delivery Centres, the HealthTech Research Centres and others. The postholder will lead work to drive the evolution of the experimental medicine portfolio and shape its future direction. In addition, they will play a key role in NIHR’s interaction with the experimental medicine community and will work closely with senior colleagues from the ___. The Programme Lead will report to the Assistant Director of Research Infrastructure, will have responsibility for the activities of a team of Senior Research Managers and Research Managers, and will work closely with the broader Infrastructure team. Key Accountabilities: Lead the delivery and strategic development of the experimental medicine research infrastructure portfolio: • Portfolio development: Develop and maintain expert knowledge of the funded portfolio in order to identify gaps or opportunities for greater impact and to build robust cases for new activities., • Strategic direction for existing funding schemes: Oversee the delivery of scheme reviews and evaluations for your portfolio to develop recommendations for the next funding calls., • Working across the health and care research landscape: Represent the schemes and portfolio in discussions with colleagues from DHSC, NIHR and beyond to ensure synergies are identified and can be capitalised on. Contribute to activities to raise the visibility of the awards within academic, clinical, public and government fora., • Commissioning of research: Provide management oversight of the delivery of new funding competitions, development of application guidance notes, the organisation of international panel meetings, the production of minutes and provision of feedback to applicants., • Development of new funding calls: Respond to ad hoc requests from DHSC/NIHR to develop and deliver new priority funding calls, mobilising resources to develop an appropriate assessment mechanism and suitable monitoring processes., • Contract management and annual reporting: Support the team to process contractual requests/changes required during the lifetime of an award and requests for information (e.g. Parliamentary Questions, FOI requests or briefings for ministers). Monitor award progress through an annual reporting process and together with the Assistant Director, sign off on award holder feedback and monitor risk management., • Team Management and Support: Guide the development of the individuals within your team to allow them to reach their potential. Co-ordinate and delegate activities within your team and work together with the Assistant Director and Programme Lead for Applied Health Infrastructure to share learning and ensure consistency across the broader infrastructure team. Support efficient ways of working whilst maintaining attention to detail and delivery to deadlines., • Stakeholder engagement: Deliver productive relationships with key stakeholders including Infrastructure Centre Directors. Work with the Directors to develop and support the implementation of collaborative working between individual awards and schemes. Oversee the co-production of strategically relevant agenda for Infrastructure Centre Directors’ meetings and other fora to keep NIHR researchers abreast of the latest initiatives and policies., • Flexible support to team: provide a high level of support across the infrastructure team and NIHR, engaging on projects and working groups as required., • Line Management: This post will be responsible for a team of six, with direct line management of three team members. Required Knowledge, Experience and Technical Skills: Required Criteria • A PhD degree (or equivalent) in biomedical or health sciences research (or significant equivalent sector experience), • Significant relevant experience of managing research funding in a clinical, academic, industrial, funding agency or charity setting, • Experience of line management, staff development and planning and monitoring of workloads, • Excellent project planning and management skills; able to prioritise and manage multiple tasks, working to challenging targets and deadlines, • The ability to demonstrate an understanding in the strategic issues in health and care research funding and policy, especially within experimental medicine, • Strategic thinker able to interpret complex information while having a clear view of the “big picture”, • The ability to employ creative approaches to effectively communicate complex information to individuals and groups from a range of different backgrounds and different seniority levels, • Committed team player with an ability to build effective working relationships Desired Criteria • Understanding of research impact and how monitor and measure it Why work for us Join our team and you’ll be working with an exceptional organisation who manage high quality health and care research for the benefit of patients and the public. NIHR is one of the UK’s largest funders of health and care research. Compensation, Benefits & Working Arrangements: Salary: Commensurate with experience Location: Twickenham, London / Hybrid working model Contract Type: Full Time,12 months fixed term contract Working Hours: 37.5 hours per week, 7.5 hours per day Annual Leave: 25 days, plus UK public holidays Employee Benefits Include: Annual bonus, subject to company performance Enhanced Contributory Pension Scheme Life Insurance Cover Benenden Healthcare Membership Training and Development Opportunities Season Ticket Loan NB: We offer a range of work life balance and family friendly, flexible working arrangements. This is an office-based, hybrid role with an expectation for all employees to attend our offices a minimum of 4 days a month, usually worked as 1 day per week, and may increase, subject to team requirements. How to Apply If you are excited about the prospect of joining our team and believe you possess the relevant skills and background, we invite you to apply. Please submit your CV along with a 'Statement of Suitability' that showcases your key skills and experiences in relation to the 'Required Criteria' outlined in the job description. Additionally, share your enthusiasm for working with the LGC Group The closing date for applications is 5pm on the 15th December. Company Statement LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, colour, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, colour, race, nationality, ethnic or national origins, religion or belief, age or trade union membership.

Job Title: Global Regulatory Lead (GRL), Senior Regulatory Program Manager Job Type: Full-time permanent position Location: West London, UK – 3x a week in the office Salary: £90,000 - £100,000 + Car Allowance + Bonus Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical device,s and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations, and interpretations. Coordinates, reviews, and may prepare reports for submission. Role responsibilities: • Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders., • Lead interactions with the health authorities/ local agencies – MHRA, EMA & FDA.This will be including pre submission meetings, pre-IND meetings, Scientific advice and type B/C meetings with the FDA., • Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs., • Confident in doing submissions in global markets with a main focus on the UK, EU, US, and ROW., • Support and lead cross functional team discussions with medical, quality, PV, and other departments. Requirements: • A scientific degree is essential., • Proven track record of leading successful European (CP, DCP, MRP), European national and US submissions., • Confident in leading global RA strategies., • Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery., • Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs., • Ability to clearly convey and exchange information with internal and external stakeholders. This role is a very senior role within the regulatory team and within any other business, it may be titled an Associate Director. You will need at least 8 years of relevant regulatory experience, ideally within a large pharmaceutical business. All the Regulatory team members attend the office 3x a week, so you would be expected to attend the office on a hybrid basis in White City, London. For more information, please reach out to me at

Agency: The Best Connection, Staines Branch.

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