Interim Senior Non-Clinical Manager

The Interim Senior Non-Clinical Manager, will advise internal and external stakeholders on strategies to assess the non-clinical characteristics (pharmacology and toxicology) of candidate cell and gene therapies and tissue engineered therapeutics, plan studies to meet the regulatory requirements, complete non-clinical gap analyses and represent the Cell and Gene Therapy (CGT) Catapult and Collaborating Organisations in Regulatory Agency Scientific and Innovation meetings. The Interim Senior Non-Clinical Manager should be able to implement optimal non-clinical strategies and deliver high quality non-clinical and other supporting regulatory submissions for each programme in agreement with the Head of Non-Clinical Safety, Head of Regulatory Affairs, Chief Clinical Officer (CCO), and other stakeholders.Key Accountabilities:Providing advice to internal and external stakeholders on non-clinical packages.in support of regulatory filings, including gap analysis and the design and conduct of studies.Support non-clinical managers during programme execution to ensure compliance with and adherence to project plans, regulatory requirements and to identify, evaluate and rectify problems; maintaining good communication with the project manager.Prepare non-clinical aspects of regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards.Familiar with detail of regulatory agency non-clinical safety requirements for cell and gene based therapies and GLP regulations.Develop protocols and review study reports as well as other essential documents required to perform non-clinical studiesApply the principles of the 3R’s to all non-clinical programmes.Develop and maintain constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management.Provision of non-clinical work-packages for grant applicationsTo review literature and attend conferences to keep abreast of developments in ATMP development, with a strong focus on pharmacology / toxicology.Understand the way in which ATMPs are being developed and advise the business on any new developments.Help to develop the “CGT Catapult brand” in terms of style and content of bid response in the areas of ATMP development.Ensure that strong links are maintained with business development, communications and other operational areas in order to keep an integrated approach to ATMP development solution provision.Play a personal and “hands-on” role in advising on specific studies or programmes (with Business Development and Programme Managers).Expand influence beyond non-clinical safety assessment into forward and backward translation of discovery and clinical activities.To elevate the scientific standing of the CGT Catapult by publishing in peer-reviewed journals and presenting at scientific meetings.This a senior position but will have no direct reports, therefore the building of relationships and having influence in a matrix environment is critical.Where different approaches are required from other therapeutic modalities the Interim Senior Non-Clinical Manager will be an advocate for best practice.Coach and mentor other scientists as necessary.Ensure a high level of familiarity with the pipelines of key Collaborators, including very frequent face to face / ear to ear contact.Work with the CGT Catapult Business Development group to ensure new opportunities are progressed and our capabilities effectively communicated.Help to ensure that the non-clinical business has a strong external and internal scientific profile, this will include the Interim Senior Non-Clinical Manager’s own participation in industry conferences and events.Participate in relevant, non-clinical focused, industry bodies where appropriate.Experience:Experience of working on non-clinical aspects of novel cell and gene therapies.Experience of animal models for assessment of efficacy, pharmacology and safety.Experience of working in a GXP environment.Experienced in generating study protocols and reports.Experience of regulatory documentation preparation and interactions with regulatory agencies.Experience in the academic grant application process would be advantageous.Experience of regulatory requirements for bioanalytical assay development and validation would be advantageous.Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK.Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success.An expert in ATMP therapeutic development and a high level understanding of other therapeutic modalities.High level interpersonal, communication skills and emotional intelligence.Experience of standard Microsoft packages.A “roll your sleeves up” hands-on attitude towards varying work assignments.A positive attitude towards learning, personal and professional development and travel.Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, with a strong attention to detail.Demonstrable experience in managing research and development projects in an academic or industry environment.A proven history of management skills in project delivery.Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities.Flexibility towards work assignments and new learning.Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks.Ambitious, collaborative, driven.Good external facing skills and ability to build relationships essential.Comfortable operating autonomously once goals and objectives are set.Able to evaluate complex situations and find solutions for them in a professional manner.Accurate with strong attention to detail.Ability to quickly establish credibility and build rapport and trust.Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs.High degree of motivation, problem solving skills and innovative thinking.A good team player with a hands-on approach, and adaptable to new challenges.Good public speaker with strong external and internal scientific credibility.Good coach and mentor.Demonstrated skills in scientific collaborations and a publication record in peer reviewed journals.Good public speaker with strong external and internal scientific credibility.Good coach and mentor.Demonstrated skills in scientific collaborations and a publication record in peer reviewed journals.Keeps up to date with professional knowledge, expertise and best practice.Willingness to travel.Education / Qualifications:A PhD (Biological Sciences) with a minimum of 10 years’ experience (or BSc with commensurate industry experience) in research and development including non-clinical study strategy, study design and management.
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