Website Lenox Executive Search
1 Year Contract – Potential to Extend
We are seeking a highly motivated scientist to join our Research and Development site in Boston, MA. This individual will be working in a dynamic, cross- functional environment spanning early and late clinical development. The Biomarker Associate will act as an important contributor to clinical development of novel therapies to treat rare diseases.
Work cross-functionally in a fast-paced environment to manage aspects of study design and clinical protocol review, biomarker sample collection, consent, handling, and analysis. The successful candidate manages timelines for biomarker projects and provides clear communication across all relevant groups and departments to ensure understanding of the goals, strategy, results dissemination and to ensure appropriate resourcing.
- Work with colleagues in Biomarkers and Imaging for the implementation of biomarkers in clinical studies to meet program goals through a translational understanding of the disease state and treatment modalities.
- Maintain close contact with the Biomarker and Imaging program leadership to communicate biomarker activities.
- Serve as a key member of study execution teams, providing input to teams and guiding clinical implementation of biomarkers.
- Develop sample handling guideline for sample processing and manage aspects of biomarker sample collection and consent.
- Develop study dossier, vendor management plan, biomarker analysis plan with vendor, track and ensure biomarker samples are analyzed in a timely manner.
- Respond to questions from sites/CROs about collection of biomarkers and from Clin Ops regarding stability and shipping of biomarker samples.
- Work collaboratively in a cross-functional setting, including Medical, Data Management, and Biostatistical functions to ensure biomarker data is transferred for analysis.
- Manage work with CRO on biomarker assays during conduct of clinical trials, as needed.
- Responsible for long term sample storage and destruction of biomarker samples from clinical studies.
- A BS in Biology or related field with 4-6 years or MS with 2 years of relevant industry experience.
- Excellent written and oral communication; organized and detail-oriented; ability to prioritize and plan
- Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation
- Knowledge of Good Clinical Practices, clinical study design and implementation is a plus but not required