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DIRECTOR OF IMAGING AND MEDICAL PHYSICS
4 weeks ago
Role Description and purpose:
A key member of the Blue Earth Diagnostics Research & Development (R&D) team, the Director of Imaging and Medical Physics will provide technical expertise across all non-clinical and clinical research activities. They will define the strategy and drive the delivery of the imaging component of diagnostic radiopharmaceutical R&D programmes, managing relationships with external parties such as Imaging Core Labs (ICLs). The Director of Imaging and Medical Physics 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
- Technical and strategic medical physics oversight of Blue Earth Diagnostics (BED) sponsored studies and support to the development of BED’s clinical development strategy.
- Management and leadership of the Imaging and Medical Physics function including line management of a team of medical physicists and imaging project managers.
- Management and delivery all outsourced imaging and medical physics work including vendor selection, contracting and associated budget management and oversight.
- Assist Clinical Operations in the setup, execution, and close-out of clinical studies, including the provision of technical expertise for the development of study documents (e.g. imaging component of the Clinical Protocol, Imaging Manual, Independent Review Charter etc.) whilst remaining compliant with ICH-GCP. Participate in site selection with respect to scanner qualification, acquisition protocols and training. Manage the transfer of images collected within a study and of contracted central blinded imaging reads. Support the analysis & interpretation of imaging data.
- Provide leadership in resolving imaging issues and/or risks including analysing, developing, and implementing action plans to address issues with investigator sites, ICLs, and vendors.
- Responsible for the maintenance and continuous improvement of imaging systems and processes.
- Contribute to New Drug application (NDA) / Market Authorisation Application (MAA) documentation with respect to imaging specific sections.
- Support the management of external scientific / clinical collaborations with investigative sites.
- Undertake due diligence on imaging and medical physics data packages to support the evaluation of potential new radiopharmaceutical opportunities for the Blue Earth pipeline, undertaking gap analysis and rigorous in-depth assessment.
- Assessment of information to identify and enable pursuit of IP claims for imaging.
- Collaborate, through close and frequent interactions, with other key functions including Medical, Clinical Operations, Biometrics, Regulatory Affairs and Quality Assurance.
- As a representative of Blue Earth, responsible for clear and confident communication with external parties and effective internal and external stakeholder management.
- Maintain oversight of relevant imaging and medical physics literature, evaluating the significance of emerging data.
- 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 medical physics or equivalent research experience
Professional Experience, Knowledge & Technical Skills
- A background in research and development, in a pharma or biotech company or Imaging Core Lab/CRO, preferably in diagnostic radiopharmaceutical development; experience in oncology is required
- Experience in global clinical trials is essential, with experience from early to late-stage drug development.
- Ability to write and edit technical documents, such as imaging component of the Clinical Protocol, Imaging Manual, Independent Review Charter.
- Must be able to evaluate, interpret and synthesise scientific data, and verbally present and critically discuss scientific data at internal and external meetings
- Experience in the preparation of the imaging components of regulatory submissions (e.g., IND, NDA, MAA) is desirable.
- Proven vendor management skills including negotiating contracts and budget oversight.
- Must have a good understanding of the drug development process and the regulatory environment
- Proven leadership promoting motivation and empowerment of others to accomplish individual, team and organizational objectives. Proven ability to coach, develop and educate staff.
- Demonstrable project management and execution skills with experience of budget management
- Thorough understanding of EMA, FDA, ICH and GCP guidelines.
- A driven, results oriented manager with extensive people management experience and demonstrated ability to form, lead and manage a team effectively to achieve challenging goals.
Soft Skills – Company Values & Behaviours
- Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.
- Excellent oral & written communication skills.
- Excellent interpersonal skills, including communication verbally and in writing. Ability to influence and build relationships in a global organisation
- Excellent organisational skills, including multitasking, efficiency, punctuality, and project management
