Careers

We are currently based in Stevenage, UK and Ambler, PA in the US. Our team is expanding.  We provide extraordinary career opportunities for talented individuals, who will have the opportunity to work with highly experienced leaders in science and business with proven track records in building successful businesses.  Our success depends on the quality, experience and ambition of the individuals that join our team.

This is an opportunity to help build Gyroscope into a world class gene therapy company, so if you would like to become a part of our dynamic team and contribute towards preventing the devastating impact of sight loss, please contact: recruitment@gyroscopetx.com

Gyroscope is an equal opportunity employer committed to a culturally diverse and international team.

Please note that Gyroscope does not accept speculative applications from recruitment agencies.

Open Positions

To take the next exciting step in your career, please review our list of current openings and job descriptions below. To apply, please submit your CV and a cover letter to recruitment@gyroscopetx.com

Gyroscope does not accept speculative applications from recruitment agencies.

 

Location: Ambler, PA

The Finance Business Partner (FBP) role spans the full finance activities of Orbit, and requires close teamwork with the Financial Accounting Manager and FP&A Manager, both of which are UK based, and have accountability for the wider Group finance.  The scope of the role is US Operations of Gyroscope (mainly Devices), but also any activity involving US operations which links to Gyroscope’s capabilities globally.

The FBP is responsible for providing financial advice, challenge and support to the business management of the US Operations of Gyroscope, in order to help drive and monitor the business in line with its strategy over the long term, as well as against in-year budget targets.  The Finance Business Partner will provide leadership and judgment in identifying and supporting value creating activities throughout the enterprise, exerting influence across all operating areas. He/she will support the Financial Accounting Manager in delivering the accounting and reporting requirements of Orbit, including monitoring the transactional accounting and book-keeping activities, ensuring the closing process and delivery of relevant financial information, statutory accounts, tax and VAT returns, capital structure and equity scheme requirements, other regulatory requirements, and audit liaison.    This includes the development of a well-controlled process and system for billing out staff time to customers.

The FBP will work closely with the FP&A Manager to ensure that high quality management information is generated on a timely basis, both historic and forward looking.  This includes supporting the development and maintenance of budgeting and planning tools to be used across the entire Gyroscope company. The Finance Business Partner interacts closely with the Extended Leadership Team, the FP&A Manager and the Financial Accounting Team.    External interactions include auditors, key suppliers, and key customers.

Key accountabilities:

Financial Planning & Analysis

  • Ensure financial considerations and constraints are taken into account in setting strategic direction for all US operations, and for any Gyroscope operations worldwide which involve US based activities
  • Ensuring optimal resource allocation in the short and long term, including cost control, ad hoc investment analysis, understanding operational variances
  • Leading the planning process (budgets, forecasts) for US operations, including preparation of P&L, Balance Sheet and Cashflow forecasts, and contribute to the preparation of funding proposal documents ahead of each funding round.
  • Providing financial management information to business management, whether via standard reports directly out of the ERP, or specific analysis

Accounting

  • Interacts closely with the Financial Accounting Manager, ensuring compliance with relevant accounting policies and standards, on-time internal and statutory reporting (monthly and annual) in line with relevant accounting standards (GAAP and IFRS)
  • Oversee the monthly and annual closing processes. Record activity and maintain ledgers, ensuring balance integrity, and a close monitoring and review of accruals and provisions
  • Ensures compliance with VAT and Tax submissions and payments
  • Ensures capital, share structure, and employee share schemes are organized optimally
  • Liaison with external auditors
  • Support the development of the internal control framework
  • Supervisor (dotted line) to the local members of the Financial Accounting Team, to ensure accounts payable, accounts receivable, travel expenses, credit card and banking processes operate effectively at Orbit. Strives to recruit and develop best in class team members.

Systems / Controls

  • Payroll – manage the Orbit payroll process (TBC)
  • Supports a well-controlled procurement process
  • Development and maintenance of finance policies and controls, and strives for best in class finance processes
  • In conjunction with Financial Accounting Manager, implement, develop, maintain a fit for purpose ERP and associated systems (such as Travel & Expenses, Billing, Inventory management)
  • In conjunction with FP&A Manager, ensure planning and analysis tools are fit for purpose, and able to support management needs  

What we look for in your skills and experience:

  • Strong understanding of industry and demonstrated knowledge/capabilities in the areas of financial accounting / standards (ie US GAAP, IFRS)
  • Broad and in-depth finance knowledge with the ability to translate financial information clearly to non-finance individuals and provide definitive financial advice.
  • Excellent planning, organizing and leadership/supervisory skills, including engaging/influencing peers and others without direct authority.
  • Knowledge of forecasting, planning & scenario building. Previous experience with budget preparation and analysis essential, ideally within a multi-country operation
  • Excellent verbal, written and presentation skills.
  • Grasp of numbers and ability to work with complex business models. Proactive problem solving ability.
  • Strong IT skills, always being ahead of new technologies. Competent to guide provide technical specification of requirements for integrated accounting systems, business analytic tools and report generating software.

Education and Qualifications

Bachelor’s degree in business or finance; CPA strongly preferred. Must have demonstrated experience (minimum 10 years) in senior finance leadership roles including FP&A, Finance Business Partnering and Accounting.  Experience within start-ups or small companies is preferred.

 

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Location: London (Kings Cross)

The Finance Business Partner – UK is responsible for providing financial advice, challenge and support to the business management of Gyroscope, in order to help drive and monitor the business in line with its strategy over the long term, as well as against in-year budget targets.

The scope of the role is the full group operations of Gyroscope including the consolidated plan for the full group, plus a specific focus on business partnering with any activities operated in the UK.

The Finance Business Partner – UK interacts closely with the Extended Leadership Team, the Finance Business Partner – US and the Financial Accounting Team.   He/she will ensure the production of high quality and insightful management information, both historic and forward looking.    External interactions include auditors, key suppliers, and key customers in due course. 

Key Accountabilities:

Planning

  • Ensure financial considerations and constraints are taken into account in setting strategic direction
  • Ensuring optimal resource allocation in the short and long term, including cost control, ad hoc investment analysis, understanding operational variances
  • Leading the planning process (budgets, forecasts) for the company, including preparation of P&L, Balance Sheet and Cashflow forecasts, and preparation of funding proposal documents ahead of each funding round.
  • Providing financial management information to business management, whether via standard reports directly out of the ERP, or specific analysis
  • Development and maintenance of budgeting and planning tools

Analysis

  • Develop fit-for-purpose reporting from the Gyroscope ERP system, including project /cost centre/ divisional reporting
  • Providing financial management information to business management, whether improving reports directly out of the ERP, or specific analysis or management reports
  • Interacts with Accounting & Reporting team to ensure the accuracy of monthly financial data and balance sheet integrity, monitoring and reviews accruals, reserves and balance sheet reconciliations
  • Work closely with the FBP – US to ensure that seamless, high quality management information is generated on a timely basis, both historic and forward looking

Other

  • Support the R&D Tax Credit administration and claims process
  • Supports a well-controlled procurement process
  • Development and maintenance of finance policies and controls
  • Support ERP implementation and future developments to ensure fit for purpose in terms of planning and analysis needs 

Education and Qualifications:

Bachelor’s degree in business or finance; CPA/ACA strongly preferred. Must have demonstrated experience as a senior finance business partner and/or Finance Business Partner – UK.    Experience within start-ups or small companies is preferred.

Apply +

Location: Stevenage

This is a great opportunity for a committed drug discovery project manager to work closely with a cross-functional team, delivering cutting edge, genetically defined therapies for the treatment of eye conditions.  As the project manager, you will work closely with Research, CMC, Clinical and Regulatory teams to manage the alignment of project activities with deliverables, accurate RAID logs and will contribute to project budget management.  You will  be a proactive, detail orientated individual with a style that ensures effective interfacing with cross-functional teams and you must have the ability to manage stakeholders  and be comfortable working in a fast-paced R&D environment.

Ideally this is for someone who wants to develop their experience/career in Project Management further.

Reporting into the  Director of Programme Management,  you will work on projects with a forward-looking perspective to ensure that the programme management department grows in line with a rapidly evolving R&D business unit.

Key Responsibilities

  • Maintains accurate, integrated project timelines.
  • Comfortable aligning budget management with project plans.
  • Identifies issues and facilitates problem-solving, contingency planning, and decision-making.
  • Utilises and helps direct the evolution of collaborative team communication solutions
  • Experienced in organising meetings, taking notes and preparing minutes.

Experience

  • Proven project management experience within the pharmaceutical, biologics and/or biotech sector.
  • Dedicated project manager of preclinical programmes with clinical operations exposure an advantage.
  • Competent user of project management software solutions. MS Project experience an advantage.
  • Professional PM qualifications (PMP, Prince2, or similar) are an advantage
  • Degree/MSc in Biomedical sciences/Chemistry

Other Experience/Abilities:

  • Must be professional, dedicated, detail-orientated with a level of gravitas
  • Excellent oral and written communication, interpersonal, analytical, and computer skills
  • Strong organisational skills required, including good time management skills
  • Highly organised and able to work independently on multiple tasks in a fast-paced environment

We are not looking for any help from agencies on this. Please do not send any speculative CVs/profiles to Gyroscope.

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Location: Ambler, PA

Gyroscope Therapeutics is developing gene therapy beyond rare disease and using it to treat a leading cause of blindness, dry age-related macular degeneration (dry-AMD). Currently, 35 million people are affected by dry-AMD around the world and there are no approved treatments.

Our investigational therapy, GT005, is designed to restore balance to a part of our immune system called the complement system. The goal is to slow, or possibly stop the progression of dry-AMD. Patients in our Phase I/II clinical trial receive a single dose therapy through a one-time procedure into the back of their retina.

We are looking for Senior Clinical Project Managers who will work as the lead Study/Program Operational Clinical Project Manager, support the design, planning and execution of assigned clinical studies to support product development, regulatory submissions and post-market evaluation.

The Senior Clinical Project Manager will be responsible for clinical operational oversight as well as the execution of all assigned studies, monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans and supporting third party vendor relationships.

What we want to see in your professional experience:

  • Responsible for the oversight and day-to-day management of clinical operations activities e.g. budgets, milestones, deliverables and timelines, for one or more clinical studies
  • Responsible for the oversight and management of fully outsourced clinical studies from protocol development through to clinical study report
  • Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives
  • Act as the key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to project team and other stakeholder groups
  • Support and monitor CRO and third-party vendor activities, including study set-up, project management, monitoring, data management, biostatistics and clinical study report
  • Monitor progress of studies, identify study-related trends/issues and work with the Director of Clinical Operations and CRO to implement corrective actions when necessary
  • Travel to include attendance at Vendor Meetings, Investigator Meetings, Society Meetings, recruitment motivational visits and to conduct co-evaluation visits with CRO monitors
  • Prepare and/or review Study Plans, Vendor Specifications and Scopes of Work
  • Contribute to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements
  • Drive the identification and selection of clinical trial investigators as per clinical operations strategy
  • Review and maintain QMS for clinical programs
  • In conjunction with Surgical Liaison/Director of Clinical Operations develop Surgical Manual and Training Plan
  • In conjunction with Project Director, develop and maintain Study Risk Management Plan
  • Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites
  • Work with Research Dept and specialist laboratory vendors to ensure clinical biological sample collection, shipment, storage and analysis
  • Coordinate and lead contract and budget negotiations with sites and third party vendors
  • Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy
  • Prepare study training materials and present at Monitors Workshops and Investigator Meetings
  • Maintain study trackers to provide financial and management accountability
  • Set up and chair study meetings, including DSMB, Steering Committee and/or Advisory Board
  • Act as Sponsor representative and key point of contact for Investigators, KOLs and other external parties
  • Ensure study certifications, insurance, licenses and registrations are maintained
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Location: Stevenage for 3 days and 2 days from home. Can work from London Office for 1-2 days.

Gyroscope Therapeutics is looking for Senior Clinical Project Managers who will work as the lead Study/Program Operational Clinical Project Manager, support the design, planning and execution of assigned clinical studies to support product development, regulatory submissions and post-market evaluation.

The Senior Clinical Project Manager will be responsible for clinical operational oversight as well as the execution of all assigned studies, monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans and supporting third party vendor relationships.

What we want to see in your professional experience:

  • Study set-up and management of global phase I-III studies including study set-up, project management, monitoring, data management, bio-statistics and clinical study report
  • Site, CRO and vendor management experience
  • Evidence & experience of your input into study design
  • Writing key study documents contributing to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements
  • Demonstrable experience of regulatory and ethics submissions
  • Management of study contracts and budgets including maintaining study trackers to provide financial and management accountability
  • Pharmacovigilance & Safety monitoring experience
  • Data Management and monitoring

It would be great to see (but not essential):

  • ATMP/GMO/Biologics handling
  • Working within a small to mid-sized biotech
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Location: Stevenage/travel to London Office (Kings Cross)

You have worked for small to mid-sized companies and love what  you do but feel that you  need an opportunity to build some thing from scratch, where the real value of what you can do  shows and is appreciated.  The mission and value of what you are doing is still important but somewhere along the way you have realised that you want to work with a company when it is at its infancy and you want to give it the benefit of your experience, skills and wisdom. You want to get that energy, when you were at your peak, back. Read on, this might be serendipitous.

Scope 

The Associate Director/Director for IT will be responsible for the IT operations and strategy that ensures that IT services meet the requirements of our fast growth business in UK and US. This will include a wide range of activities, from the strategic review of our service deployment, to managing major incidents and diving into desktop user support needs. The successful candidate will have brilliant knowledge of best practice process in IT service delivery, be a hands-on problem solver, have the ability to lead from the front and to communicate effectively with multiple stakeholders.

The primary purpose of this role being to ensure that a high performance, robust and resilient IT infrastructure is provided to the business, focusing on the global internal customer experience. This is a hands-on role which includes the operations, strategy and execution which means, for example, that on any day you may be setting up equipment to having vendor meetings to presenting to the leadership on your plan.

Responsibilities:

  • Ownership and accountability for the IT operations and strategy and global IT infrastructure including networking, telephony, internal systems, technical support and asset management.
  • Coordinating the workload and workflow of the IT Department effectively.
  • Evaluating user needs and system functionality, to ensure that IT facilities remain fit for purpose.
  • Proactively ensuring the highest levels of systems and infrastructure availability
  • Managing ‘crisis’ situations, which may include complex hardware or software problems.
  • Provide direction and in particular drive forward new and existing IT department projects
  • Participate in the design of information and operational support systems and be fully hands-on
  • Developing, managing and delivering effective IT strategies.
  • Identifying and implementing technology to innovate and improve key business processes.
  • Managing a consistent platform for all user software, hardware and databases that is stable, secure, reliable and scalable as the business grows.
  • Managing the IT department’s workload to ensure IT issues are resolved within agreed SLAs using KPIs and other objectives and measures.
  • Preparing and managing the annual IT budget.
  • Managing all outsourcing and supplier relationships.
  • Serves as focal point for all inter-office IT-related matters company-wide.

What we look for in your skills and experience:

  • Experience of working in a very fast-moving global organisation
  • Excellent and proven technical skills across Microsoft technologies
  • IT Infrastructure and Communications proficiency: Microsoft Environments (SharePoint, Windows Server, Exchange, Active Directory,…), Networking (routing, switching, LAN, WAN…)
  • Hands on – can troubleshoot and resolve technical issues not matter how small
  • Excellent communication skills, written and oral and the ability to tailor that communication to both technical and non-technical audiences.
  • Bachelor’s Degree in Computer Science, Information Systems, Engineering, Business or technical discipline or relevant experience
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Location: London (Kings Cross)

The Complement Expert will act as scientific lead for New Target Identification, develop and refine new complement-based assays and will coordinate assay development activities across project boundaries with other functional areas within Research. The expectation is that this individual will represent Research on project teams. The successful candidate will have the ability to complete work in a resourceful, self-sufficient manner and is able to design research projects to achieve desired outcomes.

Key Responsibilities:

  • Responsible for scientific insights related to driving new target discovery, understanding of mechanism of action, and rationale for indication expansion
  • Represent Research within multidisciplinary project teams
  • Contributes to technical assessment as part of due diligence activities
  • Participates in the selection of CROs and academic collaborators via technical assessments
  • Collaborates with project team to develop study designs
  • May assist in the preparation of internal documents and Regulatory submissions, including authoring (under supervision)
  • Performs other duties as assigned

What we look for in your skills and experience:

  • Proven track record in identifying and validating targets within Complement biology
  • Possesses a distinguished record enabling the goals of the assigned projects
  • Demonstrates excellence in his/her own discipline and/or area of pursuit
  • Demonstrated strong aptitude to lead a group or team endeavour, and building team unity
  • Demonstrated project management experience
  • Skilled in designing research projects including short and long-term plans
  • Demonstrated ability to compile and analyse study data with limited oversight
  • Excellent verbal presentation and written skills
  • Demonstrated ability to solve complex problems to attain crucial project goals

Qualifications:

  • Ph.D. or M.Sc or B.Sc  with demonstrable experience
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Location: London (Kings Cross)

We are currently seeking a highly motivated Research Associate to join our Translational Research team. This position will report into the Senior Scientist – Translational Research.

The Research Associate will assist in the development and validation of immunoassays and cell-based assays (including pharmacokinetic, immunogenicity, biomarkers and others as needed). The scientist will work within Gyroscope’s research team to develop and oversee assays that will be used for internal developmental work or placed at Contract Research Organisations (CROs) or academic establishments. This scientist should be proactive, inquisitive and a self-starter who is eager to learn and thrives in fast paced environment.

The position will be primarily based in London although some travel to our facilities in Stevenage may be required.

Key Responsibilities

  • Hands-on development and validation of immunoassays and cell-based assays
  • Assist and/or train others when appropriate.
  • Evaluate new assay technologies and other applications for improved performance and efficiency of laboratory activities.
  • Preparation and maintenance of accurate laboratory records
  • Performs other duties as assigned

 What we will look for in your skills and experience:

  • Hands-on experience with cellular and biochemical immunoassays such as ELISA, western blotting, cell-based assays, qPCR
  • Experience of assays used to measure immunogenicity is an advantage
  • Experience in cell and tissue culture, working under aseptic conditions.
  • Experience working in a GLP/GCP compliant environment is preferred, although full training will be given if required.
  • Ability to prioritise and deliver projects on time
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Please apply with your CV and Cover Letter, highlighting your interest and relevant skills.

Location: London (Kings Cross)

We are currently seeking a highly motivated Senior Translational Scientist with strong a strong immunology background to join our Translational Research team. This position will report into the Scientific Director.

The Senior Translational Scientist will act as an expert in the development, validation, transfer, and troubleshooting of immunoassays and cell-based assays (including pharmacokinetic, immunogenicity, biomarkers and others as needed). The scientist will work with Gyroscope’s research and clinical teams to develop and oversee assays that will be used for internal developmental work or placed at Contract Research Organisations (CROs) or academic establishments. In addition, the scientist will anticipate obstacles related to methodology and will troubleshoot and resolve these obstacles. This scientist should be proactive, inquisitive and a self-starter who is eager to learn and thrives in fast paced environment.

The ideal candidate will have pharmaceutical industry experience in the development of biologics and be lab based. Ideally, this individual will have knowledge of relevant global health authority guidelines and industry practices relating to assay development and validation. Excellent communication practiced through oral, written and presentation skills is required.

The position will be primarily based in London although some travel to our facilities in Stevenage may be required.

Key Responsibilities

  • Develop, validate, transfer and troubleshoot immunoassays and cell-based assays internally and at contract research organisations
  • Provide scientific oversight to contracted immunoassays including review of validation protocols and reports.
  • Develop close and effective partnerships with other nonclinical and clinical pharmacology scientists, safety scientists, research scientists, clinicians and project teams to foster a collaborative work environment.
  • Complete projects and prepare reports appropriate for internal or external parties within agreed timelines.
  • Represent Translational Research within multidisciplinary project teams
  • Assist and/or train others when appropriate.
  • Evaluate new assay technologies and other applications for improved performance and efficiency of laboratory activities.
  • Prepare presentations and represent research internally and externally.
  • Maintain awareness of current developments in the field through comprehensive reading of the literature and attendance at appropriate scientific meetings.
  • May assist in the preparation of internal documents and Regulatory submissions, including authoring (under supervision)

Required attributes:

  • Working knowledge and hands on experience with a wide range of cellular and biochemical immunoassays and state-of-the-art molecular biology techniques is a must.
  • Expertise in immunogenicity-related and/or complement-related immunoassays is an advantage.
  • Experience with bioanalytical method development, validation and troubleshooting of immunochemistry and immunoassay techniques including multiplex approaches e.g. Luminex or MSD platforms.
  • Demonstrate scientific creativity, critical thinking, and analytical problem-solving skills, with a strong track record of research productivity as evidenced by high-quality publications.
  • Experience with guidelines and/or working in a GLP/GCP compliant environment.
  • Experience of working with biological samples obtained from clinical trials.
  • Experience of biomarker development.
  • Strong scientific skills with the ability to collaborate with project team members.
  • Excellent collaboration, communication and decision-making skills.
  • Demonstrated ability to solve complex problems to attain crucial project goals.

Qualifications:

  • Ph.D. in a Biological Science (e.g., Immunology, Biochemistry, Cell Biology, Bioanalytical or a related field) with relevant industry experience preferably within the biotech / pharmaceutical sector.
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Location: Ambler or Baltimore, USA

We are looking for  a Director CMC Supply Chain to develop external drug product viral vector manufacturing and QC capabilities through internal process and analytical development to establish toxicology, drug product and clinical trail supplies.

The key responsibilities of the Director CMC SupplyChain are:

  • Manage CMC workstreams supporting technology transfer, GMP manufacture and PPQ activities, lead QbD risk-based assessments through acting as a conduit between analytical development, QC and PD teams in Gyroscope CMC team and selected CMOs.
  • Responsible for sponsor oversight of plasmid, vector GMP and clinical trials supply chain contractor’s implementation, delivery and continuous improvement of adequate programmes for:
    • technology transfer, qualification and validation
    • stability studies
    • facility, equipment and utility qualification and validation
    • cleaning validation
    • and shipping, storage and distribution validation.
  • Ensure that systems and controls for qualification and validation activities meet standards and applicable regulatory requirements for late stage clinical and commercial AAV (and starting raw materials) manufacture.
  • Prepare Validation Master Plans.
  • Review and approve validation protocols and reports for completeness, GMP compliance and quality of data.
  • Project manage external validation programmes to include; agreeing and communicating scope and timescales, setting budget, identifying required resources (internal and external).
  • Support, as required, concurrent analytical and bioanalytical validation activities.
  • Liaise with Quality Control, Quality Assurance and Regulatory functions to ensure that scope, execution and reporting of validation meets required expectations.
  • Participate as required in Quality audits, PAI and other regulatory inspections as client representative
  • Supply Chain Work with external stakeholders to implement and manage a secure supply chain for sourcing key GMP materials to support clinical commercial manufacture and supplies. Interface with internal stakeholders (technical leads, clinical operations and regulatory) to ensure and oversee uninterrupted late stage clinical IMP and drug product supply.
  • Implement and standardise best sourcing and security of supply practices
  • Manage RFI and RFP activities
  • Help with implementing systems for supply chain risk mitigation and supplier performance monitoring. Participate in initiatives to identify cost savings opportunities and optimise cost of goods manufactured (COGM) Manage implementation, qualification and validation of new processes developed as required into the commercial supply chain. Collaborate with QA on supplier qualification and supplier initiated change controls

What we are looking for in your experience:

  • Solid, demonstrable industrial experience in biotechnology GMP manufacturing environment
  • Demonstrated outsourcing management experience
  • Demonstrated late stage product validation experience
  • QbD knowledge/experience
  • Supply chain management experience
  • Experience with viral or gene therapy products and production
  • Drug development experience
  • Expertise in GMP manufacture of viral (gene therapy) and microbial (DNA) products
  • Thorough understanding of cGMPs and life cycle approach to process qualification and validation
  • Detailed knowledge of the practical and theoretical requirements of validation projects, including facilities, process equipment, utilities, cleaning and computer systems.
  • Understanding and experience with facility design, commissioning and validation.
  • Previous successful interactions with regulatory agencies.
  • Evidence of cross-group collaboaration and team skills

Education: 

  • BSc in biochemical engineering, biological or pharmaceutical sciences
  • Masters/PhD post graduate qualification preferred
  • Project Management qualification desirable
Apply +

Location: Stevenage/flexibility in working from our London office in Kings Cross

The Associate Director of Regulatory Affairs role will participate in the development, review and execution of regulatory strategy within the regulatory sub-team and will take the lead delivering regulatory activities/submissions necessary to support global product development and registration.

The successful candidate will be part of a team that is using innovative and pioneering technology to treat a debilitating blinding diseases, which may become the standard of care in the future – experience in developing this technology will be exciting and rewarding.

This position will report into the VP, Regulatory.

The key responsibilities of this role will be to:

  • Lead the preparation of high-quality regulatory documents and dossiers including, but not limited to, IMPD/CTA/IND, FDA briefing packages, scientific advice briefing packages, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings.
  • Provide strategic and tactical input to project and regulatory sub-teams in all aspects of regulatory affairs
  • Act as regulatory contact point Gyroscope’s interactions with regulatory authorities
  • Manage external vendors (consultants, CROs and regulatory authorities)
  • Play a leading role in contributing to the growth of the regulatory affairs function,  supporting GxP compliance and inspections
  • Remain expert and up to date on global regulatory requirements for ATMPs
  • Keep abreast of relevant regulatory intelligence and ensuring this is effectively disseminated within the organisation.
  • Assist with training of staff in regulatory matters as required.

What we will look for in your experience and skills:

  • Solid, demonstrable experience in regulatory affairs, with experience in biotechnology/biologicals – particularly ATMPs – development gained in industry or service provider environments.
  • Experience of European and US regulatory affairs e.g. CTA/IND/MAA/BLA preparation and submissions. Experience with medical devices and in vitro diagnostics a plus
  • Knowledge and understanding of US, EU and ICH guidelines and experience of working to GxP. Understanding of in vitro device/companion diagnostic regulations is a bonus.
  • Experience of planning meetings with the FDA, the EMA and European national regulatory authorities.
  • Demonstrated ability to support creation and execution of effective regulatory strategies and developing solutions for solving regulatory problems.
  • A track record of successful interactions and submissions with regulatory agencies including EMA, European national agencies and the FDA and vendors/consultants.

Education

  • BA/BS in the life sciences or equivalent work experience is required.
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Location: Ambler, PA

The Director of Regulatory Affairs will be responsible for taking the lead in delivering regulatory activities/submissions necessary to support global device development and registration, as well as supporting in the development of Gyroscope’s gene therapy portfolio.

The successful candidate will be part of a team that is developing innovative and pioneering technologies to treat a debilitating blinding diseases, which may become the standard of care in the future.

This position will report into the VP, Regulatory.

The key responsibilities of this role are:

  • Lead global regulatory activities to support all aspects of Gyroscope’s surgical device development, registration and commercialisation
  • Contribute to US regulatory activities supporting the development of Gyroscope’s gene therapy pipeline
  • Manage the preparation, submission and management of high-quality regulatory filings including but not limited to 510(k)’s, I513(g) Pre-Subs, IDES, EU Technical Files and CERs
  • Act as regulatory contact point Gyroscope’s interactions with external partners, consultants, CROs and regulatory authorities.
  • Contribute to the growth of Gyroscope’s regulatory affairs function, including regulatory operations, supporting compliance and inspections.
  • Remain expert and up to date on global regulatory requirements.
  • Keep abreast of relevant regulatory intelligence and ensuring this is effectively disseminated within the organisation.
  • Assist with training of staff in regulatory matters as required.

What we will look for in your experience and skills:

EXPERIENCE:

  • Solid demonstrable regulatory affairs experience in medical devices. Regulatory experience with biotechnological/biological products a plus.
  • Demonstrated Knowledge of regulatory requirements for EU CE Marking per MDD/MDR and IVDD/IVDR and for US FDA. Experience with 510(k). submissions, preferably with sole responsibility for completion.
  • A track record of successful interactions and submissions with regulatory agencies including FDA, as well as notified bodies.
  • Hands-on experience with EU Technical Files and knowledge of CE Marking requirements; Clinical Evaluation Report writing a plus.
  • Experience with other regulatory documents/submissions (US: 513(g), Pre-Subs, IDE; Canada: Class II-IV MDLs; EU: CERs).

Education

  • BA/BS in the life sciences or equivalent work experience is required.
Apply +

Location: Stevenage

Gyroscope is recruiting for a clinical scientist in ophthalmology to join the clinical development group. The clinical scientist is responsible for providing scientific expertise at the project and study level in support of clinical research and translational medicine in ophthalmology. He/she will collaborate with internal and external stakeholders to plan, implement, and manage clinical research studies to ensure trial integrity and success. Responsibilities include providing scientific input to clinical development, including study design and analysis plans; evaluating and interpreting clinical data; reviewing and authoring study-related documents; supporting external collaborations and clinical advisory boards; and developing and maintaining knowledge of therapeutic areas of interest. The clinical scientist will be a key contributor to cross-functional project teams focused on the development of gene therapies for ophthalmic diseases.

The key responsibilities will be:

  • Develop expertise on therapeutic areas of interest, including endpoints and biomarkers
  • Scientific literature review and summary
  • Contribute to the translational medicine and pharmacology team
  • Writing of clinical protocols
  • Preparation of annual reports, including safety updates
  • Review of incoming clinical data
  • Collaborate with external experts and consultants

What we look for in your experience and skills:

  • PhD or MD/PhD
  • Strong scientific background with good understanding of ocular disease biology
  • Clinical or translational experience in ophthalmology preferred
  • Experience in the principles and techniques of data analysis, interpretation and characterisation of clinical relevance
  • Experience of global drug development
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Location: Ambler, PA

About Us

Gyroscope Therapeutics is a clinical-stage retinal gene therapy company, developing cutting edge medicines to treat eye diseases linked to a part of the immune system called the complement system. The company was founded to capitalize on a convergence of advancements made in the understanding of the complement system’s impact on eye disease, the genetic basis of Age-related Macular Degeneration (AMD) and gene therapy as a mode of treatment delivery.

Recently, Gyroscope Therapeutics merged with Orbit Biomedical to create the first fully integrated retinal gene therapy company with a promising investigational medicine, high quality manufacturing and a surgical platform that can support accurate, safe and consistent delivery to patients with blinding conditions.

Gyroscope’s lead investigational medicine, GT005 is being studied in the Phase I/II FOCUS trial in advanced dry AMD. GT005 is a novel retinal gene therapy that delivers a targeted, single dose treatment for the progressive visual impairment caused by dry AMD in patients by locally modulating complement activity. Gyroscope is building a pipeline of medicines for blinding eye diseases linked to the complement system.

Orbit Biomedical Inc., is a medical device company and subsidiary of Gyroscope, operating at the intersection of gene and cell therapy, engineering technology and surgeon education. Our goal is to revolutionize gene and cell therapy treatment by setting a new standard for precise, targeted surgical delivery.  Orbit Biomedical’s technology, the result of many years’ work, is designed to safely and consistently deliver gene and cell therapy medicines, initially for the treatment of retinal disease. Orbit plans to use its proprietary delivery system to support accurate, safe and consistent delivery of Gyroscope gene therapy technologies and to partner with external companies who are developing single-use cell and gene therapies.

We are at the beginning of an incredible journey and are looking for a passionate R&D professional to join our team.

Scope of role

The Orbit Team is recruiting for a top executive responsible for overseeing the overall product development/ engineering functions on a global basis for medical device engineering and product development. Responsibilities include overseeing the creation, development and design of all the company’s engineered products, engineering services, and device research function.

What you will be doing:

  • Inspire a team to advance the product pipeline and bring new products to market
  • Oversee the selection of research projects to insure they have the potential to add value
  • Design and execute a comprehensive R&D plan for the development of the company’s proprietary technologies
  • Collaborates with other functions in the company to ensure that products meet the required legal, regulatory and medical/health requirements
  • Identify new collaborative technology opportunities with leading industry partners
  • Provide technological leadership in defining the company’s corporate strategies and plans
  • Develop and execute the R&D team’s goals and objectives to achieve the plans and timelines
  • Manage the R&D budget and capital expenditures
  • Lead the R&D team and develop the company’s R&D talent
  • Foster a highly dynamic and interactive working environment
  • Grow the R&D organization by recruiting critical engineering talent and managing expansion of technical resources
  • Monitor competing and complementary technologies and companies for potential licensing or M&A activities
  • Lead various stages of product development as well as cross-functional activities
  • Bring past experience and knowledge to proactively identify potential pitfalls and challenges to all projects and products
  • Create new products and processes based on prior experience
  • Help to manage and enhance the company’s intellectual property portfolio
  • Work with external vendors and develop solid collaborations and partnerships that grow the organization
  • Professionally represent and present company technology and products to healthcare professionals, government agencies, academic and industry partners and investor groups at congresses and meetings

What we want to see in your professional career:

  • Advanced Degree in Mechanical, Biomedical or Electrical Engineering and/or equivalent relevant experience
  • Demonstrable experience in medical device R&D within a hands-on management role
  • Thorough understanding of all stages of medical surgical device product development and market introduction
  • Strong ability to apply knowledge and provide imaginative solutions to difficult problems
  • Fundamental understanding of gene therapy, cell therapy and drug development
  • Knowledge of FDA, GMP, and combination product requirements
  • Experience with ophthalmic device design and manufacturing a plus
  • Proficiency with 3D solid modeling software, MS Office, and analytical/statistical software
  • Excellent written and verbal communications skills
  • Experience of working within a diverse team in Europe and USA
  • Ability to manage multiple projects simultaneously
  • Can travel internationally for up to two-week periods

If you would like to discuss this position, please forward your resume to recruitment@gyroscopetx.com or s.bassi@gyroscopetx.com .

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