Director - Biomarker Discovery
Our client is an innovative and dynamic company, passionate about realising the power of epigenetics by pioneering new biomarker discoveries and therapeutics and are looking for a forward thinking, enthusiastic, innovative, make-it-happen Director of Biomarker Discovery.
The company's unique portfolio consists of proprietary technologies and powerful expertise in interrogating DNA methylome. They're industry leaders in developing first & best in class products and services to advance basic research, pharmaceutical discovery and development of new types of diagnostics.
With their ambitious international business plan & growth forecasts, they're looking to bring on board an experienced leader within Diagnostics & Clinical trials in the UK, EU & US.
The ideal candidate is a subject matter expert in the field of biomarker discovery & have extensive practical knowledge of lab practices, Quality Assurance and Control and US regulatory frameworks including the FDA.
The role engages with the VP of Bio-Discovery, key stakeholders, your team and colleagues across the business and with external parties in a collaborative manner where effectiveness and speed of response are aligned to meeting the objectives of the Companys masterplan critical path and overall business plans.
As part of an entrepreneurially driven company, you will thrive within an evolving business and will be a competent Change Agent and have a hands-on/will do attitude. You will enjoy being progressive and adaptable to drive the companys strategic objectives to take advantage of research and commercial opportunities that present to the Company.
You will be an organised and competent professional with exceptional interpersonal and communication skills, enabling you to successfully operate in a business environment where ethical behaviour, commercial sensitivity, confidentiality and discretion are of paramount importance.
Reporting into the VP of Bio Discovery and working closely with the companys senior management and leadership teams, this is a business-critical role, delivering the biomarker discovery CRC study, and other programmes of activity as needed.
Playing a key role in the leadership of the biomarker discovery team and reviewing, monitoring and being proactive in the development and performance deliverables of your team members
Working across teams to ensure lab workflows are validated and scalable
Ensuring all biomarker discovery and analytical validation studies at a standard suitable for regulatory agency scrutiny
Provide relevant, accurate and timely information for management reporting and Board
Understand and mitigate key elements of the company's risk profile
Construct and monitor reliable control systems
Ensure that your team complies with all legal and regulatory requirements. Critical in business-ready audits and regulatory affairs
Responsible for driving the quality initiative within the Biomarker discovery team, including recording non-conformances, carry out route cause analysis, CAPA management and and SOP development, aiming for continual improvement
Ensure that record keeping meets the requirements of auditors and government agencies
Report risk issues to the VP, CEO and the management team
Maintain relations with external auditors and investigate their findings and recommendations
Responsible for collation of information and presenting of Board collateral and oversight of the teams project plans
At a minimum a PhD and significant experience in biomarker discovery or diagnostics environment
Expert in Next generation sequencing, and experience in epigenetics or liquid biopsy
Experience working in a high through-put environment, implementing automation and process optimisation preferred
Experience in Analytical Validation of assays and taking new cutting-edge diagnostics the regulatory approvals (US and European)
Experience of technology transfer preferred
Experience in working in ISO 13485 and ISO 15189 environments
Extensive experience in diagnostics in UK and the USA, ideally within similar biotech profile
Highly commercial and delivery focussed
Strong negotiating, collaboration and influencing skills
Effective Leadership qualities
Exceptional communication and numerical skills
Strategist who is capable and takes on pragmatic delivery
Exposure to working in environments subject to fast turnaround with firm budgetary control
Experience of managing personnel that may be geographically dispersed.
Extremely proactive, flexible, adaptable
Experience of working in entrepreneurial businesses an advantage.
Experience of working in corporate environments, able to adapt learnings to a company such as ours with accelerated growth needs
Enthusiastic about change and business evolution
Your role will require some travel within the UK and abroad to further the interests of the business. Flexibility and mobility are therefore key to the role.
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: email@example.com or if you'd like to have a confidential discussion then please call 0207 822 1710. We endeavour to come back to you within 24 hours of CV submission.
Key Terms: Biomarker, epigenetics, discovery, DNA, diagnostics, clinical trial, QA, quality assurance, quality control, QC, FDA, MHRA, GMP, GCP, GLP, CAPA, SOP, NGS, next generation sequencing, next-gen sequencing, liquid biopsy, high throughput, automation, process optimisation, validation, ISO13485, ISO15189, hydroxymethylcytosine, 5-hydroxymethylcytosine, 5hmC, Director, Scientist, Cambridgeshire, Cambridge, UK