Director - Non Clinical & Translational Science

Director - Non Clinical & Translational Science

Role Description and purpose: A key member of the Blue Earth Diagnostics Research & Development (R&D) team, the Director – Nonclinical and Translational Science will provide technical expertise across all non-clinical and translational research activities. They will define the strategy and drive the delivery of the nonclinical component of radiopharmaceutical R&D programmes, managing relationships with external parties such as academic collaborators and Contract Research Organisations (CROs). They will be an integral member of R&D project teams, responsible for the design and delivery of rigorous scientific studies to generate key nonclinical proof of concept data and formal Good Laboratory Practice (GLP) toxicology programs for regulatory submissions. The Director – Nonclinical and Translational Science will be a highly motivated individual, willing to take on a broad ranging role in a fast-paced environment as part of a global project team.

Main Responsibilities, Activities, Duties and Tasks:

• Gain an overview of relevant nonclinical and translational literature, evaluating the significance of emerging data; Lead on the timely development of scientifically sound nonclinical research and development plans.
• Manage and deliver all outsourced nonclinical work (e.g. pharmacology, biodistribution and imaging studies, safety studies and formal GLP-Toxicology programs) including contracting and associated budget management, study design and conduct, and the preparation of study reports.
• Draft and review the nonclinical sections of documents for regulatory submissions and scientific publications, as well as the preparation of documents and materials for internal and external meetings.
• Collaborate, through close and frequent interactions, with other key functions including medical, clinical operations, biometrics, regulatory affairs and quality assurance.
• Undertake due diligence on nonclinical data packages to support the evaluation of potential new radiopharmaceutical opportunities for the Blue Earth pipeline, undertaking gap analysis and rigorous in-depth assessment.
• As a representative of Blue Earth, responsible for clear and confident communication with external parties and effective internal and external stakeholder management.
• Ensure the highest compliance with ‘good practice’ quality standards and regulations (GxP) and that Blue Earth’s Standard Operating Procedures are followed.

Education: Educated to at least degree level, preferably with a PhD in the life sciences or equivalent research experience.

Professional Experience, Knowledge & Technical Skills:

• A background in research and development, in a pharma or biotech company (or CRO), preferably in early-stage drug development; experience in the area of oncology is required, experience in neurology and cardiology is a plus.
• Must have an excellent understanding of cancer biology and recent developments in cancer diagnostics and therapy, with the ability to gauge a broad range of technological and scientific fields.
• Must have experience of in vitro and in vivo pre-clinical tumour models; experience of other pre-clinical models of disease pathology a plus.
• Must have experience of delivering formal GLP-toxicology studies.
• Must have experience of working in multi-functional R&D teams.
• Must be able to evaluate, interpret and synthesise scientific data, and verbally present and critically discuss scientific data at internal and external meetings.
• Must have experience of outsourcing nonclinical work and/or establishing collaborative projects using contracts.
• Must have a good understanding of the drug development process and the regulatory environment.
• Demonstrable project management and execution skills with experience of budget management.
• Research experience of radiopharmaceuticals preferred but not required.