At our Centre for Diagnostics Development (CDD) in Edinburgh, we focus on developing early-stage diagnostic opportunities to a point where they can be partnered for commercialisation and deliver real patient benefit. An opportunity has arisen for a Clinical Development Lead to join the Clinical Development team within CDD.
In this role, you will lead on Clinical Development activities and closely collaborate with cross-functional teams to support Translational Challenge project goals – which address unmet clinical needs of patients – and other strategic objectives. This is a varied role and requires an agile and pro-active approach. Key activities may include: design, implementation and monitoring of requisite clinical studies of new and modified in vitro diagnostic products; working in close collaboration with the Assay Development and Data teams to deliver clinical evaluation data to support regulatory submissions and international registration packages; acting as a subject matter expert to provide advice and support from a Clinical Development lens, on a range of initiatives at different stages; contributing to strategic development of team and organizational initiatives. You will be experienced in the procedures and principles relating to clinical development and operations, and skilled in all aspects of a clinical research program, including ethics and regulatory submissions and clinical study development and execution, ensuring adherence to global harmonized standards and regulations.
Education & experience required:
· This role requires a detailed understanding of the principals involved in in vitro diagnostic product design and usage, and the relevant scientific, statistical, regulatory and compliance requirements of clinical research.
· Have a relevant scientific background including demonstrable experience working within a clinical laboratory/research context.
· Experience in the clinical development of in vitro diagnostics (IVDs) or medical devices is highly desirable.
Skills & abilities:
· A strong collaborator, able to effectively communicate and influence a diverse range of cross-functional internal teams as well as external collaborators, stakeholders & regulatory bodies.
· Able to demonstrate a high degree of accuracy in your writing and good attention to detail for preparation of documents such as clinical protocols and regulatory submissions.
· Solutions-focused and have the innate ability for problem-solving through creative thinking.
At LifeArc, our ambition is to make life science life changing. We do this by advancing scientific discoveries beyond the lab, faster, so that they can shape the next generation of diagnostics, treatments, and cures.
Working at the cutting edge of translational science and as the early-stage translation specialists, we progress scientific discoveries on their journey to becoming a medicine, diagnostic or intervention that can improve patients’ lives. Our work begins by seeking out innovative science, then helping to develop this to a point where there is a clinical and commercial pathway for others to invest the time and money to take it further forward.
Salary will be determined by qualifications and experience along with other exceptional benefits. Because we understand everyone has different requirements, our flexible benefits allow you to choose those which are important to you. Our pension scheme offers employer contributions of up to 12%, private health insurance, and annual leave of 31 days PLUS bank holidays.
Join us, and you’ll have the scope to be creative and take measured risks. You’ll be rewarded for your curiosity, for working as one team, and for learning fast. And you’ll have everything you need to be your best every day.
Don’t meet every single requirement? Studies have shown that women and people from minority ethnic backgrounds, for example, are less likely to apply to jobs unless they meet every single qualification. At LifeArc we are dedicated in building a diverse, inclusive, and authentic workplace, so whatever your background or lived experience, if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. Our top priority is finding the best candidate and you may be just the right candidate for this or other roles.
We all have potential. At LifeArc, you’ll discover what you can really do with it.