Project Manager - Spider Web Recruitment are currently supporting this global clinical cancer genomics company in their search for a Project Manager. This company is transforming personalised healthcare in oncology by utilising the precision of circulating tumour (ctDNA) analysis. Using a simple blood sample, ctDNA testing is a new tool for oncologists to detect cancer, stratify patients, and assess individual response to treatment. Their proprietary technology is based on pioneering research from the Rosenfeld Lab at the Cancer Research UK Cambridge Institute (CRUK-CI), University of Cambridge. Their platform brings together Next-Generation sequencing (NGS) technology with proprietary algorithms and databases that guide genomic profiles to clinical outcomes. This company's ctDNA assay provides a highly sensitive analysis of a strategically selected gene panel to identify actionable mutations for oncologists to treat their patients optimally. They have recently completed a highly successful Series A fundraising of $45m to accelerate clinical studies and commercialise the company's first products.
This is a fast-paced, dynamic start-up company with founders who are pioneers in the field of ctDNA analysis. They are a dedicated team with strong foundations and leadership and are all passionate about modernising cancer care and treatment for patients. Their employees have both drive and determination to work successfully as individuals and as a team to revolutionise cancer care. As part of this role there will be international travel and collaboration between the US/UK offices that brings a global-community feel to the company as they tackle the universal disturbance of cancer together with their most advanced technology.
The company are seeking an experienced Project Manager to support the cross-functional development of their Next Generation Sequencing (NGS) products. The project manager will be responsible for the administration of projects with focus on completion of the product's design history file to include guiding the project teams through design control and risk assessment. The successful candidate will be able to partner with their project teams to move products to market as quickly as possible while maintaining high standards of quality. A strong scientific background and excellent communication skills (written and verbal) are mandatory. Experience with in-vitro diagnostics development is a plus. This is a full time, permanent position.
The key responsibilities of the Project Manager are:
- Creating, implementing and executing project plans
- Effective facilitation of project team meetings
- Creating and maintaining project records including project and design history files
- Guiding project teams through risk assessment at all stages of development
- Managing critical path items and successfully removing potential roadblocks
- Regular communication regarding project metrics with Senior Leadership Team
As the successful Project Manager, you will have a either a Bachelor's degree in biology, chemistry or similar scientific field with a minimum of 10 years of industrial experience or have a Masters or PhD with 5 years of industrial experience. Having a Prince2 qualification would be desirable in this role. You must also have practical knowledge of GMP, ISO 15189, CLIA and QSR requirements and have experience in a highly regulated industry such as in-vitro diagnostics, medical device or pharmaceuticals; IVD CE and FDA PMA/510(k) experience a strong plus.
You will also have experience in product lifecycle management utilizing Design Control and Risk Management based approaches The successful Project Manager must also have Program Management Professional (PgMP) certification or desirably, Project Management Professional (PMP) certification. You will also have experience in MS Office including Word, Excel, Project, and Sharepoint, with effective presentation and meeting skills and you must be able to manage communication and engagement across a global team. You must also be able and willing to travel to the company's site in America; approximately 20% of this role would be travel.
If you have the necessary skills and experience and would like to be considered for this opportunity, please apply by forwarding an up to date CV as soon as possible. We look forward to hearing from you.
Additional keywords: Project Manager, Project Management, ISO 15189, PgMP, PMP, Degree, Bachelors, Masters, PhD, Prince2
This vacancy is being advertised by Spider Web Recruitment, a low cost flat fee recruitment service that works on behalf of companies looking for quality candidates. We provide an online recruitment advertising and employee selection service in Suffolk, Norfolk, Essex and Cambridgeshire.
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