We are seeking a highly motivated scientist to act as a Clinical Biomarker Lead, working in a dynamic, cross- functional environment within the clinical development team to implement biomarker strategies for Vertex clinical assets. This position will report directly to the Head of Clinical Biomarkers.
- Responsible for developing the clinical biomarker strategy for programs and implementing the biomarker plan during clinical development.
- Collaborate with Research and Translational Medicine on development of translational biomarker plans.
- Collaborate with Clinical Study Teams and colleagues in Translational Medicine and Clinical Development to ensure appropriate inclusion of Clinical Biomarkers in clinical studies, including study design.
- Coordinate with Clinical Pharmacology, Biostatistics and Modeling & Simulation to support quantitative pharmacological approaches during clinical development.
- Work with Project Management to ensure the development of Companion Diagnostics in parallel to drug development as appropriate.
- Serve as a key member of project teams, providing expert input to teams and guiding clinical development of novel biomarkers.
- Manage work with CRO and/or collaborate with colleagues from Biomarker Labs to ensure fit-for-purpose validation of clinical biomarker assays prior to implementation.
- Partner with colleagues across the clinical and research organizations to foster an end-to-end view of drug development, always focusing on improving patient care.
- Identify and lead opportunities for biomarker-focused external collaboration
- A PhD and/or MD with clinical biomarker development experience (at least 10+ years post-degree industry experience in the development and execution of Clinical Biomarker strategies).
- Experience in cystic fibrosis, inflammation and/or immunology areas is desirable but not required.
- Demonstrated experience with design, execution and analysis of clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
- Innovative and able to think creatively with a strong drive toward decision making.
- Effective at building alliances across functions, based on end-to-end drug development experience.
- Excellent interpersonal and communication skills, able to drive global collaborations across a matrixed organization.
Associated topics: biopharmaceutical, dietetic, histotechnologist, medicine, metabolism, pharmacy, physiologist, physiology, transfection, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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