Our client is a scientifically cutting-edge, product-on-the-market, small molecule, mid-sized pharma developing clinical programs in pain and CNS. We are looking for a translational leader who will have key influence with multiple stakeholders and cross-functional teams. If you are looking for the next-step in your career and want a financially sound, scientifically innovative company where you can have a major impact, this could be your opportunity. Work within the clinical development team to implement biomarker strategies for clinical assets.

Key Responsibilities

  • Develop the clinical biomarker strategy for programs and implement the biomarker plan during clinical development.
  • 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.
  • 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.
  • 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 preferably in CNS or pain (at least 3+ years post-degree industry experience in the development and execution of Clinical Biomarker strategies).

To apply for this position, confidentially email us here.