Senior Research Clinician

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

Clinical Study Design:

• Act as external and internal clinical expert
• Provide medical expertise into the clinical development and business plans
• Oversee NDA and MAA submissions
• 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
• 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.

Reporting:

• 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

Stakeholder Management:

• 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

Commercial:

• 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

Competencies & Requirements of the role:

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

• Proven experience in clinical research, preferably within an R&D setting.
• In-depth knowledge of clinical trial design, methodologies, and regulatory requirements.
• Ability to lead and work within cross-functional teams.
• 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

• Active medical license to practice
• 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

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.