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Job Description
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 studies
- Apply 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 applications
- To 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.