**Senior Research Director**
About the Opportunity
In a rapidly evolving field of diagnostics, we are seeking an exceptional individual to lead diagnostic programs and advance novel diagnostic tests from biomarker translation through validation to registration.
* Provide leadership in developing clinically and commercially viable products that have a meaningful impact for patients, clinicians, and healthcare.
* Plan, manage, execute, and report on biomarker discovery, analytical, and clinical validation studies for in vitro diagnostics to meet agreed technical, development, and registration milestones.
The successful candidate will play a pivotal role in advancing cutting-edge technologies into clinically and commercially relevant products. Key responsibilities include:
* Managing external projects with diagnostics collaborators, partners, contract research/manufacturing organizations, and consultants.
* Performing and reporting data analyses of biomarker and assay performance using relevant statistical packages.
* Liaising with regulatory consultants and agencies to ensure alignment with global LDT and IVD requirements.
* Supervising, training, and managing the diagnostics team.
Required Skills and Qualifications
* PhD in Molecular and Cell Biology, Biochemistry, Genetics, Endocrinology, Immunology, or another relevant field.
* Minimum 5+ years of relevant laboratory research experience, including 3+ years as a senior scientist working in a pharmaceutical or diagnostics industry setting.
* Proven track record in clinical diagnostics development, including biomarker discovery, analytical validation, clinical validation of in vitro diagnostics for Oncology, or other relevant area.
Benefits
This role offers a unique opportunity to work at the forefront of diagnostics development and contribute to improving patient outcomes. The successful candidate will be part of a collaborative and commercially focused R&D team.
Others
The ideal candidate will possess strong planning, critical thinking, and analytical skills, with the ability to solve specific research questions and technical issues. A broad knowledge of omics techniques and immuno- and molecular diagnostic development is also essential.