Associate Director, Translational Medicine

Position Summary

The Associate Director (AD), Translational Medicine supports key activities associated with translational biology and development of the organization's proprietary inflammation and immuno-oncology antibody programs towards the clinic.  Define, validate and develop relevant biomarkers to predict and monitor in vivo drug biological activity and efficacy in disease settings.  Leverage translational biology to define and stratify patient populations most likely to benefit from novel therapeutic approaches for inflammation and immuno-oncology applications.  Contribute to the preparation of documentation required for regulatory submissions, including INDs.  Participate in the design and execution of clinical studies leading to proof of concept.

Conduct analyses of biological pathways to establish relevance to disease indications of interest to our therapeutic focus. Actively contribute to the identification and selection of new targets to sustain the company’s antibody discovery pipeline. Identify new target biology relevant to unmet medical needs associated with inflammation and immuno-oncology.

Essential Functions

  • Designs and executes translational biology studies supporting preclinical and clinical development of the organization's inflammation and immuno-oncology programs
  • Develops guidelines for selection, validation, and prioritization of translational biomarkers, ensuring alignment with our product development strategies
  • Works closely with external research collaborators and contractors for preclinical and clinical translational efforts
  • Explores biomarker identification/validation and interface with the discovery and development teams throughout the development process.
  • Represents development projects at management meetings as well to external stakeholders.
  • Works with Project Management to develop timelines and budgets, and ensure that tasks are completed appropriately - establishing and monitoring measurable research milestones.
  • Participates in new target identification, including translational biology assessment of emerging biology within therapeutic areas of strategic interest to the organization. Establishes and maintains a network of external experts for molecular and biological target identification and validation
  • Fully participates in the planning and preparation of documentation sections required for regulatory filings (e.g. INDs).  

Supervisory Responsibilities

Hire, lead, and develop Translational Medicine staff

Qualifications

Education & Experience:

  • Ph.D. in the Biological Sciences, with extensive experience in Life Sciences - at least 10 years of relevant, direct experience in preclinical clinical development up to Phase 2 clinical studies; or MD with 3-5 years’ experience in early clinical development with proven ‘translational’ expertise (clinician scientist PhD preferred).  
  • Proven scientific background with preference in the area of inflammation and immunology
  • Proven track record in the translational development of drug candidates to include drug treatment approaches, agents in development and the business landscape.

Knowledge and Competencies:

  • Ability to effectively design, execute, and troubleshoot experimental protocols to develop new methodologies. 
  • Current working scientific knowledge of cellular and molecular immunology with a basic understanding of antibodies
  • Extensive knowledge of mammalian cell culture, including standard cell biology techniques and, working knowledge of cellular signaling and ELISA assays
  • Current knowledge of the design and implementation of multi-color flow cytometry-based screening experiments
  • Familiarity with preclinical models of inflammation and autoimmune disease
  • Familiarity with database searches
  • Experience in developing fit-for purpose biomarker/bioanalytical assays
  • Experience in development of quantitative analytical bioassays from complex matrices
  • Ability to identify and implement (where and when appropriate) new technologies for the advancement of quantitative biomarker analytics
  • Must be able to manage assay development and analysis queues and timelines

Knowledge of drug discovery process and pharmacology is highly desirable