Clinical Project Manager Innovative Biotech

Job Description

A unique Biotech based on South West London are seeking a Clinical Project Manager to manage their early stage clinical development programmes to take them through the early development phase, through toxicology to launch. This role will have a significant impact on the advancement of their cutting edge COVID, cancer and flu programmes. They have developed a unique DNA technology that they are continuing to exploit this technology to develop a Cancer therapy, a COVID therapy and others under development that are prophylactic and therapeutic vaccines.Role Purpose:The purpose of the Project Manager is to lead their R&D programmes at differing stages to take these across the transalational gap and into the clinic. This is a newly created position that reflects the advancement of the company as they develop their technology. What marks this opportunity as different is the opportunity to join a rapidly developing company in a newly created position to set up systems correctly the first time. To then lead these cutting edge programmes yourself and build out this function over time. With direct influence on portfolio management and strategy development for the companyCore responsibilities includes:- Manage a variety of programmes taking these from inception to completion – taking these from concept to the clinic- Develop clinical strategies including for toxicology and pharmacology studies- Manage programmes through the clinical stages into Phase I and then II and III- Contribute to strategy with particular focus on portfolio management to identify resource constraints, relative priorities, due diligence, and strategy review.- To develop and run project management systems, working cross departmentally including R&D, regulatory, production and quality for example- Taking the responsibility of ensuring programmes are on time and on budget- Work with functional heads and VP in negotiation of contracts with 3rd parties- Develop and maintain positive relationships with 3rds parties and collaborators.Please note: The working pattern for this role is currently home based to then be a mix of remote and home working.Desired Skills and Competencies:For this opportunity, you will need to have:- Prior experience of managing early stage clinical projects for example Phase I in the Biotech, Biologics, Immunotherapy, Cell Therapy or Gene Therapy sector- Experience of non-clinical, toxicology, pharmacology and other early stage clinical programmes- Experience of working with regulatory agencies such as MHRA, FDA, EMA- Used project management tools and software previously- Life Science degree or higher qualification in a relevant areaThe Company:As a company they are developing DNA based therapies using their novel doggy bone DNA vector as well as applying their expertise to drive forward the methods for DNA manufacture using advanced in vitro methods using enzymatic processes. Which addresses the limitations of plasmid DNA and DNA Vector technologies. They have developed a revolutionary platform technology for the in vitro DNA amplification method for the production of synthetic DNA that can be used in therapeutics, viral vectors, diagnostic, and synthetic biology applications. They have 2 core areas:Their Contract Manufacturing group that was established to meet the increased demand for their novel GMP grade DNA products and vectors. Their Innovations Group focuses on research that exploits their cutting edge DNA technology and develop their manufacturing capabilities to develop products for unmet needs. With a current focus on the development of Phase I and II clinical development programmes for therapeutic and prophylactic vaccines.They are based in state-of-the-art laboratories in Hampton and are a dynamic company who are leaders in the field with great potential going forward that is now being realised as they enter a phase of growth.