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.

 

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

GCP QA Manager

The position of GCP QA Manager is a quality assurance role that will provide Good Clinical Practice support to Gyroscope’s clinical-stage programmes through the development, implementation, and execution of global clinical quality systems and processes. This position will require about 20% global travel The position will report into the Head of QA.

What we expect the GCP QA Manager to do:

  • Provide support, guidance, and oversight for clinical studies with focus on compliance with Good Clinical Practice (GCP)’s regulations and guidances.
  • Provide expert Good Clinical Practice (GCP) advice and work closely with functional groups to address compliance and quality assurance trends across Gyroscope’s clinical trials.
  • Through collaboration with related Gyroscope’s functional areas, ensure Gyroscope’s clinical trials are conducted in accordance with protocols, GCP guidelines, and applicable regulatory requirements.
  • Setting priorities for QA activities, planning and conducting audits for Drug Development, as well as at clinical sites and laboratories. Leads or co-audits vendors, internal systems, and clinical sites. Conducts investigations of GCP related issues and creates corrective action plans.
  • Having responsibility for GCP aspects of Gyroscope’s Quality Management Systems.
  • Supporting the organisation through regulatory GCP inspections and co-ordinate non-functional training. Promotes and advances quality awareness throughout the organization; coordinates and provides GCP training.
  • Reviews applicable clinical documents for accuracy and internal consistency as it applies to quality (e.g., Clinical Protocols,  Clinical Study Reports, etc)
  • Author, review and/or approve clinical SOPs
  • Manage the applicable audit schedules (clinical sites, vendors, etc). Coordinate and execute audits, generate reports and follow up CAPAs to their timely completion.

What we would like to see in your skills/experience?

  • Extensive experience in a QA function, preferably in the pharmaceutical / biotech industry with focus in clinical development and operations.
  • QA GCP experience. Minimum of 5 years’ experience in pharma / biotech in a GCP role are required
  • Excellent knowledge of Clinical Trials Regulations and guidances, including FDA, ICH, WHO, or equivalent.
  • Experience and ability to conduct and lead audits.
  • Gene therapy experience is a plus , especially in early phase trials.
  • Ability to give measured and expert advice and manage complex and sensitive QA data. Ability to present findings to a varied audience.
  • Demonstrable multitasking, project management, and execution skills. Strong writing skills with experience preparing policies, procedures, and corrective action plans
  • Excellent interpersonal skills, including communication, basic negotiation, presentation, persuasion, conflict management, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Qualifications:

  • BA/BS in life sciences, chemistry, engineering or closely related field
Apply +

Location: Ambler, PA

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Gyroscope Therapeutics is looking for a Clinical Project Manager 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 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 medium-biotech
Apply +

LOCATION: Ideally UK (London or Stevenage); potential for Philadelphia

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Head of Pipeline and Portfolio Strategy:

He/she will be responsible for a portfolio of in-house drug development programmes and partnered programmes.  This individual will also manage a team of programme directors and managers in charge of day to day management of individual programmes. He/she will work with the Chief of Staff to drive the strategic orientation and execution of the portfolio, in line with the company’s strategy.

The Head of Pipeline and Portfolio Strategy will lead the Portfolio Review Board alongside the function heads (Chief Scientific Officer, Chief Medical Officer, Head of CMC, and Head of Commercial Operations).

Responsibilities:

  • Lead the Portfolio Review Board, driving the strategic orientation and providing oversight of the entire portfolio of in house and partnered programmes, managing resource pinch points and ensuring prioritisation of resources and executive focus.
  • Define, schedule and deliver project and pipeline roadmap.
  • Present operational and strategic recommendations on the portfolio to senior executives driving decision-making and issue resolution around execution of the portfolio through the governance.
  • Develop and embed portfolio management tools and best practices across all programmes (inhouse and partnered), including programme management, governance, reporting and budget.
  • Manage resource capacity to endure delivery of projects and programmes.
  • Oversee and drive the development, maintenance, and alignment of accurate, integrated timelines, resourcing projections and dependencies (budget and people), and cross functional plans across programmes.
  • Ensure project management team’s work complies with strategy, established practices, policies, and processes.
  • Lead, manage, inspire and mentor a team of programme directors and managers to deliver an efficient project-based organisation.
  • Accountable for delivery of programme-driven business plans, budgets and forecasts as needed, reporting actual performance against plan, identifying and analysing key variances against plan, highlighting critical path activities, anticipating risks, and creating contingency plans.
  • Generate analyses to facilitate scenario planning, contingency planning, risk assessment and management, problem solving, and decision-making.
  • As Head of the PPS team, deliver independent periodic management reports (e.g. monthly reports, programme milestones, dashboards).
  • Support Business Development activities by providing high level Project Management input for due diligence efforts and on the device partnered programmes:
    <!– [if !supportLists]–>o Project manage to cost with eye on margin from partners and contribute towards device business model as it becomes defined in more detail
    o   Establish and implement standards, protocols and SOPs that can be applied consistently across device programmes
    o   Identify and strategically drive partners towards datasets to support the Orbit SDS value proposition and reimbursement strategy
    o   Support external partner discussions as required

Profile

  • Masters or Doctoral degree in biology, genetics or related field
  • Demonstrable experience in the life-sciences, pharmaceutical industry with deep experience in programme management at portfolio level in big pharma and/or biotech
  • Gravitas and credibility to gain trust with stakeholders
  • Experience in negotiation and influencing skills
  • Leadership experience in international and multidisciplinary drug development teams and broad operational experience with an understanding of drug development process
  • Expert planning and tracking skills, able to see big picture, well-organised, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management
  • Proven track record of managing and developing programme team
  • Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective collaboration.
  • Ability to analyse, synthesise detailed plans and communicate top line messages and implications to the executive team and external stakeholders
  • Experience working with external partners (eg in-licensed programmes/joint steering committee)
  • Expertise in use of project management software solutions, including skills in critical path analysis
  • Experience in Ophthalmology/gene therapy drug development would be an advantage, but not essential
  • Experience in using agile methodologies would be an advantage
Apply +

Location: San Francisco, California

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Director, Corporate Affairs Communication

The Director of Corporate Affairs Communication will set the strategy and manage the execution of Gyroscope’s external communication, internal communication, patient advocacy and community relations plans. You will be responsible for raising awareness, creating connection and inspiring confidence in Gyroscope and our ability to deliver on our promise.

Reporting to the Chief Corporate Affairs Officer, you will help craft Gyroscope’s story and build the company culture. You will partner with our People Team to build a great place to work that attracts and retains the right people. And you will take a lead role in developing relationships with patient advocates, company spokespeople, the news media and investors.

Gyroscope has an opportunity to make a big difference in the lives of patients suffering from eye diseases. We need an experienced communicator to help us tell our story.

What we expect the Director of Corporate Communications to do:

  • Develop and execute a strategic plan for:
    – External communication (Gyroscope brand, milestones, media relations, etc.)
    – Patient advocacy engagement
    – Employee communication and engagement
  • Develop and own external and internal communication channels including, company website, social media channels, intranet and internal communication channels
  • Develop and own company communication policies
  • Oversee and set standards for the Gyroscope brand, company advertising and graphic design
  • Proactively identify and create contingency plans for potential issues and crises
  • Serve as an external spokesperson for the company
  • Counsel the Gyroscope executive team on all internal and external communication matter and prepare executive for media interviews
  • Serve as a member of the Gyroscope Extended Leadership team

What we would like to see in your skills, experience and education:

  • 10+ years of experience in a communication role in the biotechnology industry preparing data announcements, launching new medicines and building company culture
  • A general understanding of industry topics including the drug development process, clinical trial design, regulatory requirements and public policy
  • Ability to work independently while also thinking across the organization and how each piece of Gyroscope connects
  • Ability to partner across the company, provide guidance and empower peers and senior management
  • Media relations experience
  • Creative approach and willingness to take smart risks with communication and program development
  • Advanced science degree (M.S., Ph.D.) ideal, but not required
Apply +

 Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Position Summary

The Director, CMC Gene Therapy Regulatory Affairs will manage the CMC regulatory submissions of Gyroscope Therapeutics throughout the lifecycle with minimum supervision, with responsibility for the execution of the regulatory CMC strategy of all submissions.

What we expect the Director, CMC Regulatory Affairs to do:

  • Create regulatory strategy and execute regulatory submissions to support CMC activities of the gene therapy programs in Gyroscope
  • Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports, agency meeting briefing documents and CMC sections of the BLA/MAA in accordance with applicable regulations
  • Manage all the regulatory submission documents and the associated supporting documents and collaborate closely with Gyroscope CMC and external vendors and collaborators
  • Closely interact with Gyroscope process and analytical development groups, QA, QC and regulatory to deliver successful gene therapy clinical trials and marketing authorizations by providing strategy guidance to the Company on CMC regulatory requirements
  • Act as liaison between Regulatory Affairs and other functional areas at Gyroscope, as well as collaborators and vendors to develop CTD modules
  • Represent Regulatory Affairs in cross-functional team meetings and translate current regulatory requirements and proposed CMC changes into practical, workable submission plans and strategies
  • Research and disseminate regulatory intelligence on trends in regulatory affairs in the CMC gene therapy space and industry standards for CMC Regulatory work.

What we expect to see in your Skills and Experience:

  • Demonstrable experience in Regulatory Affairs with a minimum of 6 years in CMC regulatory. Proven track record in CMC gene therapy is preferred
  • Bachelor’s degree in Life Sciences. Advanced Scientific or Process Engineering degree is desirable
  • Ability to manage multiple projects/submissions concurrently.
  • Strong technical writing and editing skills.
  • Comprehensive understanding of FDA, EMA and ICH requirements
  • Experience with delivery of regulatory submissions in eCTD format
Apply +

Location: London (Kings Cross) or Stevenage

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Position Summary

Reporting to the VP Clinical Development, this role will lead the design of clinical development strategy and direct the implementation of clinical trials of gene therapies in ophthalmic indications.  Responsibilities include safety oversight, clinical contribution to regulatory documents, analysis of study results, and preparation of reports for the clinical programme(s) assigned

Position Responsibilities

  • Lead clinical development programme strategy for assigned programme(s)
  • Develop expertise in clinical and translational outcomes and endpoints and contribute to the translational research strategy
  • Lead activities relating to clinical study design, preparation of protocols, clinical trials oversight, data analyses and written study reports
  • Support business development and assessment of opportunities for in-licensing and collaboration
  • Collaborate with external partners:  CROs and other vendors, including image reading centres, academic partners, industry groups
  • Provide medical input to Competent Authority and Ethics Committee/IRB submissions and support interactions with same
  • Develop and maintain relationships with KOLs and investigators, develop a broad network of experts in the ophthalmology space
  • Provide medical monitoring oversight and serve as the primary contact for the medical review of safety reports for pharmacovigilance
  • Mentor Clinical Project Managers to assure medical training on the indication of interest

Education and Experience Requirements

  • Professional credentials as a physician (MD) or equivalent (e.g. OD, PharmD).
  • Minimum of five years of clinical development experience
  • Experience in ophthalmology or rare diseases is a positive, but is not required
  • Experience in global drug development
  • Translational medicine or early clinical research experience
  • Thorough knowledge of clinical trial processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)
Apply +

Location: Ambler, PA

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

 What we expect you to do:

  • Provide clinical support for all hands-on Skills Development training and R&D development work
  • Managing training execution, follow-up training and clinical site surgery support for Surgeons and Clinical Staff
  • Develop detailed procedure training plans for execution, including budgets, facility, faculty and content needs
  • Design and refine processes for logistics and metrics tracking for continued program improvement
  • Partner cross-functionally on strategy, planning and execution for procedure development, clinical trials and commercial launch activities
  • Provide insight and feedback to appropriate internal stakeholders to ensure optimized results from the procedure training
  • Work directly with Procedure Training Operations to manage training facility equipment, supplies, instruments and materials necessary for the successful execution of Skills Development Training and R&D Program support
  • Work directly with training facilities to schedule labs, review invoices and handle discrepancies as necessary

What we want to see in your skills and experience:

  • Clinical degree such as an RN or PA or Surgical Tech, technically trained in the ophthalmic, preferably retina space or Biomedical Engineer with medical device experience, preferably in ophthalmology
  • Demonstrated ophthalmic, preferably retina, surgical procedure experience including utilization and knowledge of procedures, instruments and equipment.
  • Experience in the operating room environment.
Apply +

Location: Ambler, PA

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed. 

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Quality Assurance Engineer:

The Quality Assurance Engineer develops, coordinates, and implements various activities pertaining to the effective management of the quality management system (QMS) in accordance with 21 CFR Part 820, ISO 13485, customer requirements, and applicable standards.

What we expect the QA Engineer to do:

  • Assures medical devices are designed and developed in accordance with 21 CFR Part 820, ISO 13485, and other applicable standards/regulations
  • Member of design and development s and performs quality engineering related tasks. Examples of task include:
    • Participate in the creation and execution of functional/design requirements
    • Support risk management activities including creation of plans, reports, and FMEAs
    • Support and approve design verification/validation activities
    • Assist in the application of statistical methods
    • Participate in design reviews
    • Assure cascading of critical to quality features throughout design transfer
  • Assures device design is correctly transferred to contract manufacturers
  • Audits contract manufacturers and suppliers
  • Manages product nonconformance process and is member of Material Review Board (MRB) responsible for the investigation, corrective action, and dispositioning of product nonconformances
  • Member of Change Control Board (CCB) responsible for conducting design and documents change impact assessments
  • Responsible for customer complaint investigations and recommending corrective actions
  • Assures acceptance activities (receiving, in-process, final) are properly defined and executed.
  • Compiles data/reports for input to Management Reviews
  • Assists VP Quality & Operations in the management of corrective & preventive actions (CAPA) process
  • Participates in FDA inspections and ISO 13485 assessments
  • Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of integrity, ethics and compliance at all times.
  • Additional duties as assigned.

What we would like to see in your skills/experience:

Skills and Knowledge

  • Knowledge of applicable regulatory standards such as 21 CFR Part 820 and ISO 13485
  • Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignments
  • Demonstrated ability to organize and manage small to medium-sized projects and effectively participate in cross-functional teams
  • Hands-on experience with test equipment including the ability to understand the working mechanisms and methodologies
  • Strong written and verbal communication skills
  • Strong problem solving and organizational skills
  • Intermediate to advanced knowledge of MS Office Suite.

Physical Demands

  • Requires combination of sitting, walking and standing for prolonged periods of time
  • Occasionally uses repetitive movement of (hands, arms, legs)
  • Occasionally moves or lifts materials up to 25 lbs. assisted or unassisted
  • Vision of 20/20 (corrected or uncorrected) required
  • Operates medical device assembly, test, and inspection equipment
  • Operates computer equipment, fax/copy machines, telephone, calculator and general office equipment
  • Occasional exposure to noisy environment where hearing protection must be worn

Work Environment

  • Adhere to QMS requirements outlined in procedures and work instructions
  • Ability to work overtime and weekends as needed

Experience

  • 5 years of experience in a related industry or regulated environment (e.g., ISO 13485, 21 CFR Part 820) in one of the following functions: Quality Control, Manufacturing, and Product Development.

Education

  • Associate degree (or higher) related to life sciences or equivalent.

Travel

  • Minimal travel (possibly one to two times per year for training)

  Equal Employment Opportunity

Orbit Biomedical, a Gyroscope Therapeutics company, is committed to Equal Employment Opportunity.  It is the policy of the Company to encourage and support equal employment opportunity for all Associates and Applicants without regard to sex, age, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disable veteran or Vietnam Era Veteran Status.

 Americans with Disabilities Act

Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

 Job Responsibilities

The statements contained in the job description reflect the general duties and responsibilities considered necessary to perform the essential functions of the job and should not be considered as a detailed description of all the work requirements of the position. Orbit Biomedical may change the specific job duties with or without prior notice based on the needs of the organization.

Apply +

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
Apply +

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.
Apply +

Location: London (Kings Cross) or 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
Apply +
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