Parexel FSP are recruiting for an experienced clinical trial professional to join us as a Diagnostic Manager.
In this role you'll be sponsor dedicated to one of our key Oncology sponsors in the EMEA.
You will, ensure that innovative companion diagnostic tests or equivalent segmentation tools are delivered to our oncology drug projects.
You'll be a member of the Oncology Companion Diagnostic Unit (CDU).
Your objective will be to ensure that innovative companion diagnostic tests or equivalent segmentation tools are delivered to our oncology drug projects.
Drawing on world-class expertise and personal experience in companion diagnostic development you will ensure the adoption of Precision Medicine approaches within the business.
The role is accountable for ensuring that diagnostic tests are delivered for precision medicine projects aligned with an asset's clinical development plan.
The role holder will achieve this by drawing on in vitro diagnostic development subject matter expertise and experience from across R&D and through demonstration of strong collaboration and matrix leadership skills to ensure the implementation of precision medicine approaches that ultimately lead to diagnostic approval.
The role holder can be assigned to lead one or more global studies and will be responsible for implementing the diagnostic strategy and diagnostic testing activities.
Education, Qualifications, Skills and Experience: Essential: Bachelor Degree 5 years of relevant experience.
Experience of companion diagnostic tests or patient biomarker/segmentation tools in clinical development.
Experience of oncology and/or pivotal clinical trials.
Effective communication, stakeholder, influencing skills and programme management.
Significant understanding of the functions involved in companion diagnostic development and how they contribute to achieving successful diagnostic submissions and approvals Desirable : Ph.D. in relevant subject Significant previous experience in a similar role in different companies.
Delivery of companion diagnostics, regulatory interactions and commercialisation.
High quality scientific expertise in the field of Precision Medicine or relevant therapeutic area as evidenced by publications.
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