Owlstone Medical s mission is to save 100,000 lives and $1.5 billion in healthcare costs. We want to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease. As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS - Currently ISO9001:2015, specifically for OML s diagnostics development. Key Tasks / Accountabilities Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes. Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint. Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule. Perform desk-based, remote and on-site audits of sub-contractors and suppliers. Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS. Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program. Support Quality department initiatives as required, as part of a multi-disciplinary team. Requirements Education and Training Degree level qualification within Life Sciences (or equivalent) Competencies / Requirements Essential Planning and Organising Self-Motivated and able to work independently when required Strong presentation, communication and influencing skills Pragmatic with a flexible approach and the ability to deal with changing priorities Ability to work in a dynamic environment Experience and Knowledge Suitable working knowledge within a Pharmaceutical/Medical Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, Essential: ISO 13485, ISO17025 Desirable: experience of FDA regulations and ICH requirements Desirable: experience of auditing Suppliers to ISO13485 Desirable: Regulatory experience including post market surveillance Experience of an Electronic Document Management System Experience of using an Electronic Quality Management System (ideally Q-Pulse) Experience in using Excel and PowerPoint Skills Good inter-personal and communication skills Good organisational and time management skills
Sep 23, 2022
Full time
Owlstone Medical s mission is to save 100,000 lives and $1.5 billion in healthcare costs. We want to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease. As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS - Currently ISO9001:2015, specifically for OML s diagnostics development. Key Tasks / Accountabilities Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes. Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint. Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule. Perform desk-based, remote and on-site audits of sub-contractors and suppliers. Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS. Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program. Support Quality department initiatives as required, as part of a multi-disciplinary team. Requirements Education and Training Degree level qualification within Life Sciences (or equivalent) Competencies / Requirements Essential Planning and Organising Self-Motivated and able to work independently when required Strong presentation, communication and influencing skills Pragmatic with a flexible approach and the ability to deal with changing priorities Ability to work in a dynamic environment Experience and Knowledge Suitable working knowledge within a Pharmaceutical/Medical Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, Essential: ISO 13485, ISO17025 Desirable: experience of FDA regulations and ICH requirements Desirable: experience of auditing Suppliers to ISO13485 Desirable: Regulatory experience including post market surveillance Experience of an Electronic Document Management System Experience of using an Electronic Quality Management System (ideally Q-Pulse) Experience in using Excel and PowerPoint Skills Good inter-personal and communication skills Good organisational and time management skills
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we undertake a number of projects and activities designed to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated project coordinator to join our busy PMO and to work within our "Breath Biopsy Tests Programme". This is a pivotal role within a programme workstream. Working closely with a Principal Investigator (PI), you will take ownership for coordinating all of the various work packages and activities within a workstream. You will also work closely with the other Project Coordinators and the Programme Manager to ensure work is managed and coordinated across the whole programme. You will be expected to support the Study Lead and the Programme Manager throughout the full lifecycle of all project phases, including: Start Up - identify the customer/user and the scope of the project and work with the various stakeholders to define this in a project brief. Initiation - develop requirements and concepts, produce plans for the project schedule, resources, communication, risk and quality and develop a robust business case to form the foundation of the project. Execution - ensure that the work is managed with the focus on delivery. Understand the value and process behind good experimental design and verification and validation of results. Monitoring & Control - use a range of techniques and reporting to ensure schedule, budgets, risk, quality, scope, changes etc are under control. Closure - deliver the outputs, complete the documentation, learn the lessons! Due to the nature of research work, the projects and activities can change direction rapidly and frequently so, whilst good project management practice is a strong requirement for the role, so too is the ability to be flexible and to react positively to changing circumstances. The results of experiments undertaken in the programme will often dictate the next steps and so the whole team need to be agile and ready to revise project plans and activities accordingly. You should also expect to play a key role in the administration of Intellectual Property (IP) and Non-Disclosure Agreements (NDAs). In addition to this, you will be an active member of the PMO. This could include acting as project assurance for other projects, running or contributing to the programme of development seminars and deputising for more senior staff as required. Requirements The following competences form the core strength of the PMO. You are expected to have some knowledge of the competences and be able to demonstrate some evidence of applying some of them in uncomplicated situations: Leadership & professionalism - the ability to empower and inspire others to deliver successful projects and to act in a morally, legally and socially appropriate manner. Team management - the ability to select, motivate, develop and manage teams to achieve specified objectives and to resolve differences and conflicts between them. Stakeholder management - the ability to identify and effectively engage with all stakeholders, taking account of their levels of influence and particular interests. Planning - the ability to consolidate and document the fundamental components of a project and then prepare and maintain schedules for project activities and events. Financial management - the ability to develop and agree budgets for projects, and to control forecast and actual costs demonstrating commercial awareness. Quality management - the ability to ensure that the project outputs and processes through which they are delivered are meeting stakeholder requirements. Requirements management - the ability to capture, assess and justify stakeholders wants and needs to arrive at an agreed schedule of requirements. Risk & issue management - the ability to identify risks (threats and opportunities) and issues, assess them and plan and implement appropriate responses. Benefits realisation - the ability to manage the integration of the outputs of the project into business-as-usual in order to realise the business benefits. Governance - the ability to establish and maintain structures that define clear roles, responsibilities and accountabilities for governance and delivery of the project. Essential Requirements: Experience - you will have experience as a project coordinator / manager or in a similar role Knowledge - you will have some awareness of the regulatory issues surrounding clinical trials and research studies, e.g. ethics, data protection, etc Education - A degree in a life science discipline Communication - you will have excellent written and verbal communication skills and be comfortable leading meetings and delivering effective presentations. Information Technology - you will be competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA, MS Project, Confluence, etc. Desirable Requirements: Experience of working within an ISO 9001 Quality Management System A formal Project Management qualification (e.g. PRINCE2, MSP, APM, etc)
Sep 23, 2022
Full time
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we undertake a number of projects and activities designed to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated project coordinator to join our busy PMO and to work within our "Breath Biopsy Tests Programme". This is a pivotal role within a programme workstream. Working closely with a Principal Investigator (PI), you will take ownership for coordinating all of the various work packages and activities within a workstream. You will also work closely with the other Project Coordinators and the Programme Manager to ensure work is managed and coordinated across the whole programme. You will be expected to support the Study Lead and the Programme Manager throughout the full lifecycle of all project phases, including: Start Up - identify the customer/user and the scope of the project and work with the various stakeholders to define this in a project brief. Initiation - develop requirements and concepts, produce plans for the project schedule, resources, communication, risk and quality and develop a robust business case to form the foundation of the project. Execution - ensure that the work is managed with the focus on delivery. Understand the value and process behind good experimental design and verification and validation of results. Monitoring & Control - use a range of techniques and reporting to ensure schedule, budgets, risk, quality, scope, changes etc are under control. Closure - deliver the outputs, complete the documentation, learn the lessons! Due to the nature of research work, the projects and activities can change direction rapidly and frequently so, whilst good project management practice is a strong requirement for the role, so too is the ability to be flexible and to react positively to changing circumstances. The results of experiments undertaken in the programme will often dictate the next steps and so the whole team need to be agile and ready to revise project plans and activities accordingly. You should also expect to play a key role in the administration of Intellectual Property (IP) and Non-Disclosure Agreements (NDAs). In addition to this, you will be an active member of the PMO. This could include acting as project assurance for other projects, running or contributing to the programme of development seminars and deputising for more senior staff as required. Requirements The following competences form the core strength of the PMO. You are expected to have some knowledge of the competences and be able to demonstrate some evidence of applying some of them in uncomplicated situations: Leadership & professionalism - the ability to empower and inspire others to deliver successful projects and to act in a morally, legally and socially appropriate manner. Team management - the ability to select, motivate, develop and manage teams to achieve specified objectives and to resolve differences and conflicts between them. Stakeholder management - the ability to identify and effectively engage with all stakeholders, taking account of their levels of influence and particular interests. Planning - the ability to consolidate and document the fundamental components of a project and then prepare and maintain schedules for project activities and events. Financial management - the ability to develop and agree budgets for projects, and to control forecast and actual costs demonstrating commercial awareness. Quality management - the ability to ensure that the project outputs and processes through which they are delivered are meeting stakeholder requirements. Requirements management - the ability to capture, assess and justify stakeholders wants and needs to arrive at an agreed schedule of requirements. Risk & issue management - the ability to identify risks (threats and opportunities) and issues, assess them and plan and implement appropriate responses. Benefits realisation - the ability to manage the integration of the outputs of the project into business-as-usual in order to realise the business benefits. Governance - the ability to establish and maintain structures that define clear roles, responsibilities and accountabilities for governance and delivery of the project. Essential Requirements: Experience - you will have experience as a project coordinator / manager or in a similar role Knowledge - you will have some awareness of the regulatory issues surrounding clinical trials and research studies, e.g. ethics, data protection, etc Education - A degree in a life science discipline Communication - you will have excellent written and verbal communication skills and be comfortable leading meetings and delivering effective presentations. Information Technology - you will be competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA, MS Project, Confluence, etc. Desirable Requirements: Experience of working within an ISO 9001 Quality Management System A formal Project Management qualification (e.g. PRINCE2, MSP, APM, etc)
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Clinical Trials Coordinator (CTC) to join our team. The CTC is an external facing role. CTCs coordinate all Clinical Trial activities from set up of the documentation and initiation of the sites to site close out. CTCs are responsible for ensuring that clinical sites have all the documentation, equipment and support they need to conduct out the study. This will involve some national and international travel, sometimes at short notice. You will need the ability to coordinate and lead site interactions for multiple clinical studies of a limited complexity or provide support to a Senior CTC or Clinical Trials Project Manager for more complex trials. You will need superb communication and organisational skills as you will be supporting several studies simultaneously. Working in collaboration with the other members of Clinical Study Delivery and with a wide range of internal and external customers, this role is pivotal to the success of Owlstone. Key tasks & Accountabilities You will be responsible for all the documentation, equipment and site set up for your assigned clinical trials including those tasks typically carried out by a CTA. You will also work with Senior members of the team to support site set up for more complex trials such as CTIMPs: Responsible for preparation of study documents Assist SCTC/PM in performing submissions to EC and regulatory bodies You will be responsible for ensuring the right equipment is available and shipped to the site, conduct of a project kick off meeting and providing documentation and training on breath sample collection Oversee study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues You will ensure that all decisions are documented and that all records are accurate and kept according to the appropriate SOPs and provide stakeholder reports as required Ensure documentation is stored appropriately in the document management system Raise and log non-conformances and contribute to CAPA investigations and implementation of improvements Highlight gaps and contribute to updates and reviews of departmental SOPs Provide guidance for Clinical Trials Administrator (CTA) to set up the Trial Master File. Ensure all documentation complete and present in the TMF, through regular updates and checks throughout the study Lead internal R&D support by setting up equipment and systems appropriately, recruiting volunteers, obtaining informed consent and collecting breath samples Interface with Manufacturing and the Breath Biopsy Lab (BBL) to ensure consumable requirements are understood and accounted for during the lifecycle of the study You will ensure that returned samples are handled according to OML protocols and either passed to the lab for immediate processing or stored correctly. Ensure end-to-end testing on the software to be used for sample collection Work closely with the Clinical Data Manager, CTS and PM to build and test the eCRF (e.g OpenClinica) Responsible for ensuring sites are closed out appropriately and all equipment returned promptly Be responsible for training more junior staff and provide induction training for new starters Responsible for peer review of completed documentation and QC check of documentation preparation by CTA for delivery to external sites and customers Monitor recruitment at sites and report on status and deviations from expectations Visit clinical sites for the purpose of training, monitoring and understanding recruitment issues You may be required to visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required Requirements Essential: Experience as a CTA or similar role within clinical study delivery Experience of maintaining TMF Excellent written and verbal communication skills and be comfortable interacting with a wide range of people. Further education in a technical or science discipline or equivalent experience Experience of Good Clinical Practice Competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA and Confluence, etc. Desirable Experience working with CTIMPs Experience in a similar CTC role A good awareness of the regulatory issues and requirements surrounding clinical trials and research studies Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment Experience of setting up CRFs and performing site feasibility and initiation
Sep 23, 2022
Full time
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Clinical Trials Coordinator (CTC) to join our team. The CTC is an external facing role. CTCs coordinate all Clinical Trial activities from set up of the documentation and initiation of the sites to site close out. CTCs are responsible for ensuring that clinical sites have all the documentation, equipment and support they need to conduct out the study. This will involve some national and international travel, sometimes at short notice. You will need the ability to coordinate and lead site interactions for multiple clinical studies of a limited complexity or provide support to a Senior CTC or Clinical Trials Project Manager for more complex trials. You will need superb communication and organisational skills as you will be supporting several studies simultaneously. Working in collaboration with the other members of Clinical Study Delivery and with a wide range of internal and external customers, this role is pivotal to the success of Owlstone. Key tasks & Accountabilities You will be responsible for all the documentation, equipment and site set up for your assigned clinical trials including those tasks typically carried out by a CTA. You will also work with Senior members of the team to support site set up for more complex trials such as CTIMPs: Responsible for preparation of study documents Assist SCTC/PM in performing submissions to EC and regulatory bodies You will be responsible for ensuring the right equipment is available and shipped to the site, conduct of a project kick off meeting and providing documentation and training on breath sample collection Oversee study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues You will ensure that all decisions are documented and that all records are accurate and kept according to the appropriate SOPs and provide stakeholder reports as required Ensure documentation is stored appropriately in the document management system Raise and log non-conformances and contribute to CAPA investigations and implementation of improvements Highlight gaps and contribute to updates and reviews of departmental SOPs Provide guidance for Clinical Trials Administrator (CTA) to set up the Trial Master File. Ensure all documentation complete and present in the TMF, through regular updates and checks throughout the study Lead internal R&D support by setting up equipment and systems appropriately, recruiting volunteers, obtaining informed consent and collecting breath samples Interface with Manufacturing and the Breath Biopsy Lab (BBL) to ensure consumable requirements are understood and accounted for during the lifecycle of the study You will ensure that returned samples are handled according to OML protocols and either passed to the lab for immediate processing or stored correctly. Ensure end-to-end testing on the software to be used for sample collection Work closely with the Clinical Data Manager, CTS and PM to build and test the eCRF (e.g OpenClinica) Responsible for ensuring sites are closed out appropriately and all equipment returned promptly Be responsible for training more junior staff and provide induction training for new starters Responsible for peer review of completed documentation and QC check of documentation preparation by CTA for delivery to external sites and customers Monitor recruitment at sites and report on status and deviations from expectations Visit clinical sites for the purpose of training, monitoring and understanding recruitment issues You may be required to visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required Requirements Essential: Experience as a CTA or similar role within clinical study delivery Experience of maintaining TMF Excellent written and verbal communication skills and be comfortable interacting with a wide range of people. Further education in a technical or science discipline or equivalent experience Experience of Good Clinical Practice Competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA and Confluence, etc. Desirable Experience working with CTIMPs Experience in a similar CTC role A good awareness of the regulatory issues and requirements surrounding clinical trials and research studies Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment Experience of setting up CRFs and performing site feasibility and initiation
Owlstone Medical are looking to recruit an experienced Research Clinician to join our Breath Biopsy Tests Programme as a member of the Portfolio Leadership team. You will provide medical management and professional medical support for clinical research projects at Owlstone Medical as the assigned Medical Monitor (MM). Part of your role will be assisting in activities requiring Medical & Scientific support, including but not limited to; assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities. Working Arrangement: We are open to this role on a full or part time permanent contract. The role will require you to have a presence in our Cambridge,UK offices, however we do work in a flexible and hybrid environment so please talk to us through your interview process about what set up you are looking for. Key Tasks & Accountabilities Provide medical expertise into the clinical development and business plans Oversee NDA and MAA submissions Developing connections, leading interactions and maintaining partnerships with key opinion leaders in areas of strategic interest relating to the company s development pipeline and in particular lung cancer and liver disease. Partner with different departments across Owlstone Medical to support the development of new research pathways Provide medical oversight and provide clinical leadership on clinical trials Ensure that all ICH GCP and local regulations are met Assessing clinical evaluation claims for use Assessing clinical performance data Act as external and internal clinical expert Medically manages clinical trials to which you are assigned as Medical Monitor Medical & Safety project team to process Serious Adverse Events (SAEs) Provides therapeutic and protocol-specific training to the project teams Contribute medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers, statistical analysis plans, clinical study reports, regulatory approval submissions, etc. Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) Input into Health Economics and medical affairs Leading the publication strategy, including reviewing and developing publications, alongside presenting at conferences (these could be both in the UK and internationally). Working closely with Business Development inputting clinical and medical expertise to the identification, feasibility assessment (including unmet clinical need, assessment of competitors) and support for the commercialisation of Breath Biopsy Tests Working with the company s sales team with pre-sales clinical and medical support Requirements Education & Training Medical Doctor, preferably within Oncology Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in-person scholarly programs/lectures Experience & Knowledge Essential Experience with clinical trials either as a principal investigator/medical monitor Up to date in clinical practise, but not necessarily remaining in clinical practise Experience with clinical trials within Oncology Maintains working knowledge of cGCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards. Experience working within a relevant industry or working in partnership with, such as: CRO, Pharma or Biotech industry. Preferably as the medical monitor or principal investigator. Providing strategic and technical input into the study design and CRF design for trials Provide clinical positioning input to help support strategies for biomarker discovery Being able to represent Owlstone in meetings with regulatory authorities Desirable Hold a license to practise Medical monitoring of phase I/II clinical trials Awareness of the current medical device legislation Experience in clinical trials within Hepatology Experience of the commercialisation of diagnostic tests Experience of interacting with business development and sales in the context of medical/clinical support Development of medical/clinical strategy for diagnostic tests
Sep 23, 2022
Full time
Owlstone Medical are looking to recruit an experienced Research Clinician to join our Breath Biopsy Tests Programme as a member of the Portfolio Leadership team. You will provide medical management and professional medical support for clinical research projects at Owlstone Medical as the assigned Medical Monitor (MM). Part of your role will be assisting in activities requiring Medical & Scientific support, including but not limited to; assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities. Working Arrangement: We are open to this role on a full or part time permanent contract. The role will require you to have a presence in our Cambridge,UK offices, however we do work in a flexible and hybrid environment so please talk to us through your interview process about what set up you are looking for. Key Tasks & Accountabilities Provide medical expertise into the clinical development and business plans Oversee NDA and MAA submissions Developing connections, leading interactions and maintaining partnerships with key opinion leaders in areas of strategic interest relating to the company s development pipeline and in particular lung cancer and liver disease. Partner with different departments across Owlstone Medical to support the development of new research pathways Provide medical oversight and provide clinical leadership on clinical trials Ensure that all ICH GCP and local regulations are met Assessing clinical evaluation claims for use Assessing clinical performance data Act as external and internal clinical expert Medically manages clinical trials to which you are assigned as Medical Monitor Medical & Safety project team to process Serious Adverse Events (SAEs) Provides therapeutic and protocol-specific training to the project teams Contribute medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers, statistical analysis plans, clinical study reports, regulatory approval submissions, etc. Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) Input into Health Economics and medical affairs Leading the publication strategy, including reviewing and developing publications, alongside presenting at conferences (these could be both in the UK and internationally). Working closely with Business Development inputting clinical and medical expertise to the identification, feasibility assessment (including unmet clinical need, assessment of competitors) and support for the commercialisation of Breath Biopsy Tests Working with the company s sales team with pre-sales clinical and medical support Requirements Education & Training Medical Doctor, preferably within Oncology Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in-person scholarly programs/lectures Experience & Knowledge Essential Experience with clinical trials either as a principal investigator/medical monitor Up to date in clinical practise, but not necessarily remaining in clinical practise Experience with clinical trials within Oncology Maintains working knowledge of cGCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards. Experience working within a relevant industry or working in partnership with, such as: CRO, Pharma or Biotech industry. Preferably as the medical monitor or principal investigator. Providing strategic and technical input into the study design and CRF design for trials Provide clinical positioning input to help support strategies for biomarker discovery Being able to represent Owlstone in meetings with regulatory authorities Desirable Hold a license to practise Medical monitoring of phase I/II clinical trials Awareness of the current medical device legislation Experience in clinical trials within Hepatology Experience of the commercialisation of diagnostic tests Experience of interacting with business development and sales in the context of medical/clinical support Development of medical/clinical strategy for diagnostic tests
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are looking for an expert in the delivery of clinical trials to lead and support our internal clinical trials. To fulfil our mission to save lives, we conduct a range of clinical studies, including observational trials, first in human trials, proof of concept studies and later stage trials as required in order to support breath biomarker discovery, development and safety assessment of novel probes of metabolism and medical device development and approval. This diversity means that every study has its own unique challenges to overcome. In this role, you will work with our multi-disciplinary teams to lead and manage multiple clinical trials including CTIMPs, from the initial scoping stage through to delivery and study close out and ensuring that all clinical sites deliver and recruit as planned against the required timelines and that any issues that delay recruitment are unblocked quickly Key tasks & Accountabilities You will be accountable for managing and driving the full life cycle of the study, including outsourced components, for multiple complex research studies including CTIMPs and will be an integral part of our Programme team helping to influence and develop our strategy for the delivery of clinical trials to support each internal therapeutic area You will have the skills and drive required to step in and ensure that anything related to the implementation and conduct, that comes up during the course of the clinical study is actioned and addressed appropriately and in a timely manner. You will be responsible for the following, in addition to any additional tasks outside the scope of this job description as necessary to ensure successful delivery of a Clinical Trial: Be accountable for complex studies and/or those with high visibility such as pivotal trials or challenging POC studies Management and oversight of the conduct of the clinical trial, including responsibility for recruitment and ensuring any elements on the critical path, especially recruitment, are unblocked quickly to avoid delays Collaboration with Programme managers on timelines and delivery Contribution to the required risk management documentation, ownership for completion of identified risk reduction actions, provide guidance and support for more junior staff and ensure learnings are disseminated accordingly Management of internal stakeholders, communication and troubleshooting to ensure any issues blocking the delivery of the trial are resolved in a timely manner Study Set Up Significant input in the development of, protocol and strategy for delivery for designated trials and preparation of the appropriate documentation Development of the site monitoring plan to ensure compliance with the protocol as required and training the Clinical Monitor The quality management documentation for individual clinical trials Lead in-depth site feasibility assessments, ensuring that the selected sites are suitable for the study requirements Review and where necessary negotiate contracts to ensure all clinical activities are accounted and costed for appropriately Seek feedback from regulatory bodies and oversee submissions and approvals process, to ensure on time initiation of trials involving medical devices or CTIMPs Study Conduct Visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required and for the purpose of training, monitoring and understand barriers to recruitment Monitor and critically review the performance of different sites and feedback on this to the appropriate stakeholders and document any deviations to protocol or delivery timelines and work to unblock any issues that will impact on delivery Ensure the clinical trial, remains compliant to the quality management plan and that the data produced is handled appropriately and that the clinical data meets submission requirements Present updates and findings to both internal and external customers and collaborators, be able to influence both on the benefits of the trials being conducted and on participation Study Close Out Responsible for ensuring the study and TMF are closed out appropriately Responsible for production of the Clinical Study Report Training / and other study support Act as a coach or mentor to junior members of Clinical Study Delivery Responsible for QC check and peer review of all documentation for delivery to external sites and customers Quality Management Ensure that all decisions are documented and that all records and documentation are accurate and stored appropriately according to the appropriate SOPs and provide stakeholder reports as required Ensuring that non-conformances are logged, lead CAPA investigations and implementation of improvements Take accountability for the preparation and review of existing and new departmental SOPs, templates and forms Requirements Essential You will have demonstrable experience in a similar role leading / setting up clinical trials and working to GCP guidelines. You will have experience of management of external clinical sites in the conduct of a clinical trial You will also have experience of interacting with the MHRA (and/or other regulatory bodies), of reporting serious adverse events and working with different institutional review boards (IRBs) or ethics committees (ECs). You will also have experience of supporting a range of clinical trials including CTIMPs, from "first in human" studies to Phase 3 clinical trials. You will have an extensive knowledge and application of (amongst others) FDA regulations, GCP and ICH Guidelines for clinical research and ethical submissions for clinical trials and the regulatory / ethical requirements with regards to conducting clinical trials for CTIMPs and/or medical devices You will be educated to degree level (or equivalent), ideally in a science subject You will have excellent written and verbal communication skills and be comfortable supervising others and delivering effective presentations. You will have experience acting as a mentor or coach to more junior team members. Desirable You will have demonstrable experience in a similar senior role leading / setting up clinical trials and working to GCP guidelines. You will have experience of working within a CRO or overseeing work outsourced to a CRO. Experience of line management, team leadership, coaching or mentoring Experience of working within an ISO 9001 Quality Management System Experience of managing clinical trials performed in NHS sites and with clinical trials supporting medical devices approval
Sep 23, 2022
Full time
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are looking for an expert in the delivery of clinical trials to lead and support our internal clinical trials. To fulfil our mission to save lives, we conduct a range of clinical studies, including observational trials, first in human trials, proof of concept studies and later stage trials as required in order to support breath biomarker discovery, development and safety assessment of novel probes of metabolism and medical device development and approval. This diversity means that every study has its own unique challenges to overcome. In this role, you will work with our multi-disciplinary teams to lead and manage multiple clinical trials including CTIMPs, from the initial scoping stage through to delivery and study close out and ensuring that all clinical sites deliver and recruit as planned against the required timelines and that any issues that delay recruitment are unblocked quickly Key tasks & Accountabilities You will be accountable for managing and driving the full life cycle of the study, including outsourced components, for multiple complex research studies including CTIMPs and will be an integral part of our Programme team helping to influence and develop our strategy for the delivery of clinical trials to support each internal therapeutic area You will have the skills and drive required to step in and ensure that anything related to the implementation and conduct, that comes up during the course of the clinical study is actioned and addressed appropriately and in a timely manner. You will be responsible for the following, in addition to any additional tasks outside the scope of this job description as necessary to ensure successful delivery of a Clinical Trial: Be accountable for complex studies and/or those with high visibility such as pivotal trials or challenging POC studies Management and oversight of the conduct of the clinical trial, including responsibility for recruitment and ensuring any elements on the critical path, especially recruitment, are unblocked quickly to avoid delays Collaboration with Programme managers on timelines and delivery Contribution to the required risk management documentation, ownership for completion of identified risk reduction actions, provide guidance and support for more junior staff and ensure learnings are disseminated accordingly Management of internal stakeholders, communication and troubleshooting to ensure any issues blocking the delivery of the trial are resolved in a timely manner Study Set Up Significant input in the development of, protocol and strategy for delivery for designated trials and preparation of the appropriate documentation Development of the site monitoring plan to ensure compliance with the protocol as required and training the Clinical Monitor The quality management documentation for individual clinical trials Lead in-depth site feasibility assessments, ensuring that the selected sites are suitable for the study requirements Review and where necessary negotiate contracts to ensure all clinical activities are accounted and costed for appropriately Seek feedback from regulatory bodies and oversee submissions and approvals process, to ensure on time initiation of trials involving medical devices or CTIMPs Study Conduct Visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required and for the purpose of training, monitoring and understand barriers to recruitment Monitor and critically review the performance of different sites and feedback on this to the appropriate stakeholders and document any deviations to protocol or delivery timelines and work to unblock any issues that will impact on delivery Ensure the clinical trial, remains compliant to the quality management plan and that the data produced is handled appropriately and that the clinical data meets submission requirements Present updates and findings to both internal and external customers and collaborators, be able to influence both on the benefits of the trials being conducted and on participation Study Close Out Responsible for ensuring the study and TMF are closed out appropriately Responsible for production of the Clinical Study Report Training / and other study support Act as a coach or mentor to junior members of Clinical Study Delivery Responsible for QC check and peer review of all documentation for delivery to external sites and customers Quality Management Ensure that all decisions are documented and that all records and documentation are accurate and stored appropriately according to the appropriate SOPs and provide stakeholder reports as required Ensuring that non-conformances are logged, lead CAPA investigations and implementation of improvements Take accountability for the preparation and review of existing and new departmental SOPs, templates and forms Requirements Essential You will have demonstrable experience in a similar role leading / setting up clinical trials and working to GCP guidelines. You will have experience of management of external clinical sites in the conduct of a clinical trial You will also have experience of interacting with the MHRA (and/or other regulatory bodies), of reporting serious adverse events and working with different institutional review boards (IRBs) or ethics committees (ECs). You will also have experience of supporting a range of clinical trials including CTIMPs, from "first in human" studies to Phase 3 clinical trials. You will have an extensive knowledge and application of (amongst others) FDA regulations, GCP and ICH Guidelines for clinical research and ethical submissions for clinical trials and the regulatory / ethical requirements with regards to conducting clinical trials for CTIMPs and/or medical devices You will be educated to degree level (or equivalent), ideally in a science subject You will have excellent written and verbal communication skills and be comfortable supervising others and delivering effective presentations. You will have experience acting as a mentor or coach to more junior team members. Desirable You will have demonstrable experience in a similar senior role leading / setting up clinical trials and working to GCP guidelines. You will have experience of working within a CRO or overseeing work outsourced to a CRO. Experience of line management, team leadership, coaching or mentoring Experience of working within an ISO 9001 Quality Management System Experience of managing clinical trials performed in NHS sites and with clinical trials supporting medical devices approval
This role of Business Development Executive is based within the Sales and Marketing Team reporting to the Global VP of Sales. There will also be frequent interactions with the Field Sales, Marketing, Business Development, Manufacturing and Supply Chain teams. This would be an ideal position for someone already working within a sales or business development role, with a life science degree and excellent communication skills. The role would involve helping our VP of Sales and team of Business Development Managers sell Owlstone Medical Breath Biopsy Products and Services into academic and government institutions. This position would have a significant impact on market growth within the academic sector with a focus on the US markets, and therefore someone who is able to work a slightly delayed shift of 10:00am to 18:00 with flexibility on some later meetings is important to fulfill our US clients needs. Location: There will be the requirement to commute to our Cambridge office for training and frequently to meet with the team, please discuss during the interview process what working set up you are available for. Basic Function and Scope of the Position: Identify, qualify and develop new sales opportunities working with the relevant Business Development Manager to generate profitable revenue for the company Help to assess, qualify and develop inbound enquiries working with the relevant Business Development Manager Assess commercial value of individual prospects, based on predefined criteria and understanding of the product offering and relevant markets Engage with the marketing team across various activities for lead generation (e.g. email campaigns) Develop quarterly OKR (Objective and Key Result) plans to maximise chances of hitting team sales targets Plan, prepare and execute customer engagements with call planning and post-call documentation of meeting minutes and action items in our Confluence documentation system and SalesForce CRM Participate in relevant trade shows and conferences to generate leads and stay abreast of customer strategies, goals, and objectives and understand the competition Requirements Preferred Educational Background: Graduate from a recognized life science related degree Excellent written and oral communication skills Preferred Background/Experience: Experience in a commercial or sales role, preferably within the life sciences industry. Demonstrated ability to grasp and communicate technical concepts Strong interpersonal skills with the ability to communicate effectively with a wide range of personality types both inside and outside the company Team goal oriented and efficient time management skills Training and Growth: Along with internal training on Owlstone Medical s products and services, external sales training will be provided Opportunities to grow within the Sales team and work towards developing to the next stage in the career ladder.
Sep 23, 2022
Full time
This role of Business Development Executive is based within the Sales and Marketing Team reporting to the Global VP of Sales. There will also be frequent interactions with the Field Sales, Marketing, Business Development, Manufacturing and Supply Chain teams. This would be an ideal position for someone already working within a sales or business development role, with a life science degree and excellent communication skills. The role would involve helping our VP of Sales and team of Business Development Managers sell Owlstone Medical Breath Biopsy Products and Services into academic and government institutions. This position would have a significant impact on market growth within the academic sector with a focus on the US markets, and therefore someone who is able to work a slightly delayed shift of 10:00am to 18:00 with flexibility on some later meetings is important to fulfill our US clients needs. Location: There will be the requirement to commute to our Cambridge office for training and frequently to meet with the team, please discuss during the interview process what working set up you are available for. Basic Function and Scope of the Position: Identify, qualify and develop new sales opportunities working with the relevant Business Development Manager to generate profitable revenue for the company Help to assess, qualify and develop inbound enquiries working with the relevant Business Development Manager Assess commercial value of individual prospects, based on predefined criteria and understanding of the product offering and relevant markets Engage with the marketing team across various activities for lead generation (e.g. email campaigns) Develop quarterly OKR (Objective and Key Result) plans to maximise chances of hitting team sales targets Plan, prepare and execute customer engagements with call planning and post-call documentation of meeting minutes and action items in our Confluence documentation system and SalesForce CRM Participate in relevant trade shows and conferences to generate leads and stay abreast of customer strategies, goals, and objectives and understand the competition Requirements Preferred Educational Background: Graduate from a recognized life science related degree Excellent written and oral communication skills Preferred Background/Experience: Experience in a commercial or sales role, preferably within the life sciences industry. Demonstrated ability to grasp and communicate technical concepts Strong interpersonal skills with the ability to communicate effectively with a wide range of personality types both inside and outside the company Team goal oriented and efficient time management skills Training and Growth: Along with internal training on Owlstone Medical s products and services, external sales training will be provided Opportunities to grow within the Sales team and work towards developing to the next stage in the career ladder.
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy . This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease. The Head of Commercial, Digestive Health is responsible for all commercial aspects of Owlstone Medical s digestive health offering. We are looking for an individual that is strategic and highly organized, and has experience in telehealth business development, commercial planning, relationship skills, and contract negotiations. The ideal candidate will have significant experience in developing a telehealth business, ideally in digestive health, with pre-existing relationships in the field to further accelerate his or her effectiveness in growing the sales associated with our digestive health business. Key Tasks / Accountabilities Establish the product vision (along with the key stakeholders) and ensure the entire organisation is aligned. Be accountable for the digestive health business' revenue generation, growth and P&L. Creating and implementing a commercial strategy for the digestive health business that includes: Refining the product and service offering for our digital health solution. Identifying the channel(s) to market (both digital and bricks and mortar ). Determining subscription models and pricing strategies. Collaborating with marketing on developing the marketing plans for engagement with clinicians and consumers. Creating the overall business plan Collaborate with internal development, product marketing, marketing and business teams to ensure commercial needs and embedded into development plans and to create a focused plan to achieve sales targets. Driving revenues of our clinical, laboratory based, digestive health offering. Managing the commercial relationships with clinical partners to understand market drivers. Build a clinical network of digestive health professionals to support the digestive health solution. Develop partnership opportunities with public and private health providers to develop acceptance of the solution. Work with key opinion leaders to generate awareness and acceptance of the value of breath testing in digestive health. Requirements Essential Significant experience leading the commercial development, implementation and launch of a digital health solution (ideally a subscription based, digestive health solution) delivered digitally and through traditional channels to market. Experience of driving significant revenue growth in a telehealth business. Desirable Experience of building a clinical network to deliver digital health services Experienced in developing a telehealth service from its early-stage concepts to delivery and revenue growth Has commercial experience in both the UK and US markets Has existing commercial relationships with clinicians and private hospitals Education & Training Bachelor's Degree in a relevant field Professional Skills The ability to sell ideas, influence and persuading at all levels of the organisation The ability to work within a matrixed organisation structure Strong relationship and negotiation skills with clients and internal team members Experience of working in a fast-moving entrepreneurial organisation
Sep 22, 2022
Full time
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy . This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease. The Head of Commercial, Digestive Health is responsible for all commercial aspects of Owlstone Medical s digestive health offering. We are looking for an individual that is strategic and highly organized, and has experience in telehealth business development, commercial planning, relationship skills, and contract negotiations. The ideal candidate will have significant experience in developing a telehealth business, ideally in digestive health, with pre-existing relationships in the field to further accelerate his or her effectiveness in growing the sales associated with our digestive health business. Key Tasks / Accountabilities Establish the product vision (along with the key stakeholders) and ensure the entire organisation is aligned. Be accountable for the digestive health business' revenue generation, growth and P&L. Creating and implementing a commercial strategy for the digestive health business that includes: Refining the product and service offering for our digital health solution. Identifying the channel(s) to market (both digital and bricks and mortar ). Determining subscription models and pricing strategies. Collaborating with marketing on developing the marketing plans for engagement with clinicians and consumers. Creating the overall business plan Collaborate with internal development, product marketing, marketing and business teams to ensure commercial needs and embedded into development plans and to create a focused plan to achieve sales targets. Driving revenues of our clinical, laboratory based, digestive health offering. Managing the commercial relationships with clinical partners to understand market drivers. Build a clinical network of digestive health professionals to support the digestive health solution. Develop partnership opportunities with public and private health providers to develop acceptance of the solution. Work with key opinion leaders to generate awareness and acceptance of the value of breath testing in digestive health. Requirements Essential Significant experience leading the commercial development, implementation and launch of a digital health solution (ideally a subscription based, digestive health solution) delivered digitally and through traditional channels to market. Experience of driving significant revenue growth in a telehealth business. Desirable Experience of building a clinical network to deliver digital health services Experienced in developing a telehealth service from its early-stage concepts to delivery and revenue growth Has commercial experience in both the UK and US markets Has existing commercial relationships with clinicians and private hospitals Education & Training Bachelor's Degree in a relevant field Professional Skills The ability to sell ideas, influence and persuading at all levels of the organisation The ability to work within a matrixed organisation structure Strong relationship and negotiation skills with clients and internal team members Experience of working in a fast-moving entrepreneurial organisation
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy , which enables the non-invasive collection and analysis of biomarkers in exhaled breath for early disease detection and precision medicine. We are currently seeking a Senior Biostatistician with clinical research and biomarker discovery experience to be a member of our Clinical and Translational Science Department. The candidate will contribute to the mission of the company by providing input into clinical study designs and trial protocols and will ensure that data analysis and interpretation of results are statistically sound and meet the desired study objectives. The Senior Biostatistician will work in a cross-functional team to support Owlstone s clinical test development and customer services business. Key responsibilities: Perform appropriate statistical analyses at all phases of the project, from clinical protocol development and study design through final analysis and reporting of results Evaluate clinical research studies and prepare statistical analysis plans that provide sound approaches to support a continuum of study goals, from biomarker discovery through clinical test development Apply appropriate statistical methodologies to analyze the data, including, but not limited to, hypothesis testing, regression models, multivariate analyses, machine learning, and network-based analyses Program and analyze data using Python or R; demonstrate good programming practices through proper documentation and commenting; perform appropriate QA to ensure accuracy and consistency of results Effectively communicate statistical methods and results to cross-functional team members, clinical collaborators, and others with a variety of technical expertise (including lay audience) Maintaining technical knowledge and skills appropriate for the role, including staying current with innovative statistical methodologies that are relevant to clinical research Requirements Technical Competencies: A thorough understanding of sample size, study power, precision, and their application in clinical trials and/or observational studies Proficient in translating clinical research questions into testable hypotheses Adept in communicating the assumptions, limitations, and advantages or disadvantages of statistical methods and describing preferred alternatives when key assumptions are not met Working proficiency in Python (to the level of package writing) or R (capable of implementing statistical or computational methods) Demonstrated ability to take initiative and be proactive in your approach to work, with an independent, creative, and open mindset Desirable Experience: Statistical experience working with CROs or the biopharmaceutical industry Application of statistical design and analysis for biomarker discovery and validation Experience with metabolomics (or other omics) data from clinical or epidemiologic studies Experience working closely with clinical biologists and translational scientists to analyze and interpret clinical datasets Strong publication record or other demonstrable track record of performance and collaboration Familiarity with IRB/ethics and regulatory documentation Qualifications: PhD or equivalent combination of education, training and experience in (bio) statistics or a related discipline, preferably with demonstrable experience working in a clinical, biomedical, or commercial environment
Sep 22, 2022
Full time
Owlstone Medical ( ()) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy , which enables the non-invasive collection and analysis of biomarkers in exhaled breath for early disease detection and precision medicine. We are currently seeking a Senior Biostatistician with clinical research and biomarker discovery experience to be a member of our Clinical and Translational Science Department. The candidate will contribute to the mission of the company by providing input into clinical study designs and trial protocols and will ensure that data analysis and interpretation of results are statistically sound and meet the desired study objectives. The Senior Biostatistician will work in a cross-functional team to support Owlstone s clinical test development and customer services business. Key responsibilities: Perform appropriate statistical analyses at all phases of the project, from clinical protocol development and study design through final analysis and reporting of results Evaluate clinical research studies and prepare statistical analysis plans that provide sound approaches to support a continuum of study goals, from biomarker discovery through clinical test development Apply appropriate statistical methodologies to analyze the data, including, but not limited to, hypothesis testing, regression models, multivariate analyses, machine learning, and network-based analyses Program and analyze data using Python or R; demonstrate good programming practices through proper documentation and commenting; perform appropriate QA to ensure accuracy and consistency of results Effectively communicate statistical methods and results to cross-functional team members, clinical collaborators, and others with a variety of technical expertise (including lay audience) Maintaining technical knowledge and skills appropriate for the role, including staying current with innovative statistical methodologies that are relevant to clinical research Requirements Technical Competencies: A thorough understanding of sample size, study power, precision, and their application in clinical trials and/or observational studies Proficient in translating clinical research questions into testable hypotheses Adept in communicating the assumptions, limitations, and advantages or disadvantages of statistical methods and describing preferred alternatives when key assumptions are not met Working proficiency in Python (to the level of package writing) or R (capable of implementing statistical or computational methods) Demonstrated ability to take initiative and be proactive in your approach to work, with an independent, creative, and open mindset Desirable Experience: Statistical experience working with CROs or the biopharmaceutical industry Application of statistical design and analysis for biomarker discovery and validation Experience with metabolomics (or other omics) data from clinical or epidemiologic studies Experience working closely with clinical biologists and translational scientists to analyze and interpret clinical datasets Strong publication record or other demonstrable track record of performance and collaboration Familiarity with IRB/ethics and regulatory documentation Qualifications: PhD or equivalent combination of education, training and experience in (bio) statistics or a related discipline, preferably with demonstrable experience working in a clinical, biomedical, or commercial environment
