Associate Director/Director Clinical Biomarkers

Boston, MA 02210

Post Date: 06/01/2018 Job ID: 3057716 Industry: Scientist

Associate Director/Director Clinical Biomarkers

Our client is seeking a scientist to serve as a Clinical Biomarker Lead to implement biomarker strategies for our clinical assets.
  • Responsible for developing the clinical biomarker strategy for programs and implementing the biomarker plan during clinical development.
  • Collaborate with Research 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 Research 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

Minimum Qualifications:
  • 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.

Preferred Qualifications:
  • Preferably a PhD and/or MD with clinical biomarker development experience
  • 6-8 years post-degree industry experience in the development and execution of Clinical Biomarker strategies).

Carmela Lane

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