Project Manager – IVD (12 month FTC)

Owlstone is looking for a highly-driven, experienced Project Manager to work closely with our internal teams to ensure the successful execution of a high-value diagnostic development project. The role requires an individual with significant experience of IVD product development and understanding of biomarker and drug development from the pharma perspective

Key Tasks & Accountabilities

Working closely with key senior stakeholders, understand and develop the business requirements to the point where a project can be triggered. You will then be expected to manage the full life cycle of the development project, including:

• Work closely with the Research and Development, Quality, Business Development and Operations teams on planning and execution of diagnostic development projects
• Lead cross-functional project teams to deliver projects to agreed scope, cost, quality and timeline
• Organise and lead regular project team meetings
• Analyse, plan and track project activities, communicating progress against plan on a regular basis to all relevant internal and external stakeholders
• Identify and efficiently resolve or escalate issues and risks to stakeholders in a timely and clear fashion
• Identify resources required and manage these for all project
• Track estimated project costs and resources, and proactively communicate deviations to relevant internal and external stakeholders
• Apply project management tools and methodologies to ensure cross-functional alignment and accountability.
• Define and implement the process for IVD development within Owlstone
• Train and educate key personnel to ensure the process in embedde

Requirements

Core Competencies:

The following competences form the core strength of the PMO. You will have a detailed knowledge of, and be able to demonstrate expert experience in, applying these competences, primarily in complex situations, and can critically evaluate and adapt them as required. You will be able to supervise others in applying the competences:

• 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 strong 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.

Essential Requirements

Experience

• Managing diagnostic development projects from initiation to commercialisation in either the pharmaceutical or diagnostic industry.
• Managing new product development processes to ISO 13485 standards. Developing medical devices and invitro diagnostic tests to meet UK, US and EU regulations.

Knowledge

• Strong scientific knowledge and understanding of the principles and practicalities of biomarker and diagnostic development.
• Good understanding of Project Management principles, concepts, practices, and standards.
• Good understanding of the requirements for developing medicinal products as part of a diagnostic product.

Education

• Graduate level qualification in life, medical sciences or associated discipline

Communication

• Strong presentational skills, including communicating to senior stakeholders internally and externally.
• Engaging with technical teams to ensure effective solutions to design and development challenges.

Desirable Requirements

• A formal Project Management qualification (e.g. PRINCE2, MSP, APMP, PMI. PMP etc)
• Experience of implementing project management approaches to the development of IVD products

Benefits

About Owlstone Medical

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.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using

Owlstone is an equal opportunity employer, and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and the attainment of a Baseline Personnel Security Standard (BPSS) check. Access to selected project information requires prior additional security authorization. Access to US technical data by employees requires prior Export Control function approval. Full clearance must be satisfactorily attained against all applicable project security and US export control authorisations. Failure to meet any reference, BPSS, project-security or export-control authorisations may have an impact on successfully completing your probationary period.

Notice to agencies

Owlstone Medical Ltd politely requests no contact from recruitment agencies or media sales. We don’t accept speculative CVs from recruitment agencies nor accept the fees associated with them.