Location: South UK based – some remote working possible
Our client is a world-leading liquid biopsy company with sample-to-answer solutions. Its proven patent-protected platform is a circulating tumour cell (CTC) harvesting technology using a bespoke system. The 1st product has launched and is the 1st system to ever be FDA cleared for harvesting CTCs for subsequent analysis.
They are now seeking a CSO to provide oversight and support for the Head of R&D and maintain technical standards and processes and oversee all verification and validation activities. The role holder will work closely and in full coordination with the Clinical Studies Director and regulatory affairs and participate in regulatory discussions with the FDA and other regulatory bodies.
This role will lead the development of clinical applications, as well as collaborations with tie-in medical technologies and outsourced projects with KOLs. Critical will be acting as a thought leader maintaining an in-depth working knowledge of the sector, and remaining current with emerging industry trends. The role holder will identify new functionality to meet business needs and foster knowledge sharing as well as representing the Company in a variety of external forums such as scientific and industry conferences, advisory boards, meetings with regulators and payors, as well as investor meetings and calls.
The role demands an advanced degree in oncology, and molecular/cell biology plus significant industry experience, including oncology, medical device/diagnostics or in combination, with biopharma experience, and must have brought novel products/tests to the market, including clinical applications, and have worked in a clinical services lab setting. Have established KOL relationships in oncology & diagnostics is essential. The role holder must have the presentation skills to be highly credible in front of US investors, and large-scale corporate partners, including in pharma drug development.
The role requires knowledge of quality systems, design controls and medical device regulatory requirements in the various global markets and exposure to cancer drug trials and the relevant networks. The person will need to demonstrate an understanding of how CTC cells can benefit drug development. The role holder must be prepared to travel as required to the Surrey site in the UK, with additional travel within North America one week per month.
The role demands strong business acumen with the ability to identify clinical and commercial opportunities, and have a proven record in leadership and staff management, while functioning in a demanding, hands-on, and action-oriented environment with an understanding of the complex commercial needs for clinical, medical device development, whilst also being able to navigate the practicalities and challenges of development and implementation in a research setting.