Clinical Development Associate
LifeArc is a self-funded medical research charity. Our mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients. We have been doing this for more than 25 years and our work has resulted in four licensed medicines and a diagnostic for antibiotic resistance.
Our success allows us to explore new approaches to stimulate and fund translation. We have our own drug discovery and diagnostics development facilities, supported by experts in technology transfer and intellectual property who also provide services to other organisations. Our model is built on collaboration, and we partner with a broad range of groups including medical research charities, research organisations, industry, and academic scientists. We are motivated by patient need and scientific opportunity.
As part of the Clinical Development Team, the Clinical Development Associate contributes to ensuring the smooth running of Clinical Development activities, engages with new and existing networks to identify sources of clinical samples and build relationships with key opinion leaders and other stakeholders. They work in collaboration with the Assay Development Teams to execute feasibility, full product development and clinical evaluation studies for new and modified in vitro diagnostic products according to established policies, procedures, regulations, and Good Clinical Practice (GCP).
This role demands a high level of accuracy, meticulous attention to detail and the ability to complete tasks within specified timelines. You will participate as an active member of a multi-disciplinary team to implement, evolve and support clinical development strategies and performance/clinical evaluations for diagnostic development projects. Candidates will already have established a high degree of competence in clinical research studies and have a working knowledge of molecular techniques such as qPCR and NGS. They will thrive in a dynamic, multifunctional and continually evolving role and work independently with a significant degree of autonomy to carry out requisite tasks. International travel to visit collaborators/partners/clinical sites and to co-ordinate clinical studies/trials is an absolute requirement of the role.
You will have a background in Biomedical Sciences/Biology or other relevant Life Science subject. Industry experience is highly desirable, as is experience of working with human clinical samples in a clinical research or ISO accredited laboratory environment. Experience in monitoring of clinical studies, bioinformatics (with respect to clinical studies), medical writing and/or clinical sample/tissue procurement could be advantageous. You will be conversant with the principles of ICH GCP, SOPs, regulatory requirements and legislation pertaining to the conduct of clinical evaluation studies for in vitro diagnostics. You will enjoy working within a dynamic multidisciplinary team and be confident in seeking out and liaising with existing and new stakeholders.
Your salary will be determined by qualifications and experience. In addition, LifeArc offers a defined contribution pension scheme, private health insurance, a flexible benefits scheme and 31 days paid holiday per year.
LifeArc is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
To apply please email your CV and covering letter explaining why you want to work for LifeArc to: or by post to Recruitment, LifeArc, Accelerator Building, Open Innovation Campus, Stevenage, SG1 2FX (electronic applications preferred).
Closing date: Monday 8th March 2021
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.