Job summary
The Project:
For over 20 years, GOSH working in partnership with the Great Ormond Street Institute of Child Health (ICH), has been at the forefront of developing and delivering transformative gene therapies for rare, inherited diseases. The new Cell & Gene Therapy Good Manufacturing Facility in the Zayed Centre for Research has been opened to build on this expertise and to increase the capacity and broaden the scope for manufacturing at GOSH. As part of GOSH's commitment to tackling rare childhood disease, GOSH is embarking on an ambitious project (GOSH MAH Project) to address a critical need in the rare disease space not adequately met by commercial entities due to economic constraints. In the current healthcare landscape, despite their clinical effectiveness, certain rare disease advanced therapies have been withdrawn by commercial developers due to a lack of commercial viability. GOSH is committed to finding an alternative approach to prevent these proven treatments failing to reach patients due to commercial challenges.
Main duties of the job
The project manager will work together with the MAH Project Lead and multiple internal and external teams to develop a pipeline model of sustainable manufacture and delivery of advanced therapies with a not-for-profit approach.
The initial stages of the project will require development of user requirement specifications and solution scoping for the systems and infrastructure required for GOSH to establish itself as a marketing authorisation holder. These will include a regulatory compliance and information management system, a GVP compliant pharmacovigilance system for licensed medicinal products, and a patient registry data collection tool required to provide ongoing safety monitoring of ATMPs following market authorisation. The project manager will work closely with the MAH Project Lead and internal teams to develop detailed project implementation plans and budgets needed to establish these systems and infrastructure.
The project manager may also be involved in supporting the planning and preparation of a market authorisation application and NICE Health Technology Appraisal for a candidate gene therapy.
The postholder will be an experienced highly motivated and capable individual with a strong track record in project management, GXP quality systems and/or Pharmacovigilance. Experience with post authorisation regulatory management of medicinal products would be an advantage.
About us
We are keen to make our workforce as diverse as the communities we serve, and we hope to attract applications from underrepresented groups, including people with Black, Asian and Minority Ethnic heritage, people with a disability, and people from LGBTQ+ communities. By growing an ever more diverse workforce, we'll have a greater range of perspectives and knowledge, meaning that we can provide the children and young people at our hospital with even better care.
Our hospital is committed to creating an environment that is open and inclusive. Our staff are encouraged to engage with colleagues through the following networks: REACH (Race, Ethnicity and Cultural Heritage) ENABLED (Enhancing Abilities & Leveraging Disabilities Network), PRIDE and Women's networks; all of which are sponsored by a member of our Executive Management Team.
We want to ensure that all of our people, regardless of their background, are seen and heard. We want to attract applicants that share our commitment to inclusion and that understand diversity is a strength that is embraced and valued.
Job description
Job responsibilities
Please see the Job Description attached.
This job description is intended as an outline of the areas of activity and can be amended in the light of the changing needs of the service and will be reviewed as necessary in conjunction with the post-holder.
Job description
Job responsibilities
Please see the Job Description attached.
This job description is intended as an outline of the areas of activity and can be amended in the light of the changing needs of the service and will be reviewed as necessary in conjunction with the post-holder.
Person Specification
Values
Essential
- Gosh Values
- Experience of working as part of a diverse team.
- Experience of contributing to an inclusive workplace culture.
Academic/Professional qualification/Training
Essential
- First degree or equivalent professional qualification
- Experience in project management
- Training in GCP
Desirable
- Postgraduate qualification in relevant area
Experience/Knowledge
Essential
- Demonstrable experience of Good Clinical Practice and an understanding of gene and cell-based therapies.
- Demonstrable experience of planning and e complex projects.
- Experience in understanding technical discussions and documentation.
- Experience in dealing with sensitive and confidential information
- Experience of project and/or solution scoping
- Experience of costing and preparing complex project budgets.
- Experience in quality management in a GXP environment
- Experience in pharmacovigilance and safety reporting for clinical trials or licensed medicinal products
- Experience in electronic case report forms (eCRF) systems
Desirable
- Demonstrable experience of negotiating with and motivating teams, including external collaborators/partners to ensure project delivery
- Experience in clinical trial management
- Experience of interactions with and submissions to regulatory agencies for clinical trials or market authorisations.
- Experience in working with regulatory information management systems
- Knowledge of GxP computer systems validation
Skills/Abilities
Essential
- Excellent interpersonal skills. Ability to engage and motivate others
- Excellent communication (written and oral) and presentation skills;
- Willingness to learn and adapt to new challenges
- Technical aptitude and analytical skills. Ability to critically assess and problem solve.
- Proactive in identifying and resolving issues.
- Proven organisational and project management skills
- Ability to work collaboratively and as part of a team but be able to function independently and effectively without supervision.
- Takes responsibility for own actions and promotes good team working; treats others with courtesy and respect at all times
- High level of attention to detail
- Proactive / uses initiative
- Effective spoken and written English
- High level of computer literacy to include word-processing, spreadsheet, and presentation software
- Demonstrated ability to prioritise and meet deadlines
- Preparation of high-quality written documents
Person Specification
Values
Essential
- Gosh Values
- Experience of working as part of a diverse team.
- Experience of contributing to an inclusive workplace culture.
Academic/Professional qualification/Training
Essential
- First degree or equivalent professional qualification
- Experience in project management
- Training in GCP
Desirable
- Postgraduate qualification in relevant area
Experience/Knowledge
Essential
- Demonstrable experience of Good Clinical Practice and an understanding of gene and cell-based therapies.
- Demonstrable experience of planning and e complex projects.
- Experience in understanding technical discussions and documentation.
- Experience in dealing with sensitive and confidential information
- Experience of project and/or solution scoping
- Experience of costing and preparing complex project budgets.
- Experience in quality management in a GXP environment
- Experience in pharmacovigilance and safety reporting for clinical trials or licensed medicinal products
- Experience in electronic case report forms (eCRF) systems
Desirable
- Demonstrable experience of negotiating with and motivating teams, including external collaborators/partners to ensure project delivery
- Experience in clinical trial management
- Experience of interactions with and submissions to regulatory agencies for clinical trials or market authorisations.
- Experience in working with regulatory information management systems
- Knowledge of GxP computer systems validation
Skills/Abilities
Essential
- Excellent interpersonal skills. Ability to engage and motivate others
- Excellent communication (written and oral) and presentation skills;
- Willingness to learn and adapt to new challenges
- Technical aptitude and analytical skills. Ability to critically assess and problem solve.
- Proactive in identifying and resolving issues.
- Proven organisational and project management skills
- Ability to work collaboratively and as part of a team but be able to function independently and effectively without supervision.
- Takes responsibility for own actions and promotes good team working; treats others with courtesy and respect at all times
- High level of attention to detail
- Proactive / uses initiative
- Effective spoken and written English
- High level of computer literacy to include word-processing, spreadsheet, and presentation software
- Demonstrated ability to prioritise and meet deadlines
- Preparation of high-quality written documents
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Zayed Centre to Research into Rare Disease
20C Guilford Street
London
WC1N 1DZ
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
