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Principal Scientist – Translational Medicine – Immunology

Principal Scientist – Translational Medicine – Immunology

CompanyInventing for Life
LocationBoston, MA, USA, North Wales, PA, USA, San Bruno, CA, USA, Linden, NJ, USA
Salary$255200 – $401700
TypeFull-Time
DegreesPhD, MD
Experience LevelSenior, Expert or higher

Requirements

  • MD or MD/PhD
  • Proven track record in clinical medicine or clinical research, and background in biomedical research.
  • Demonstrated record of scientific scholarship and achievement including publications or presentations.
  • Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.

Responsibilities

  • Key member of an early development team, providing leadership in designing and executing early clinical development strategy.
  • Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development.
  • Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, electrophysiological and behavioral responses to interrogate biological activity in humans.
  • Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways.
  • Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).
  • Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations.
  • Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees.
  • Contribute to assessment of internal and external opportunities identified by Business Development and Licensing.
  • Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world.

Preferred Qualifications

  • Clinical Board Certification or Eligibility.
  • Prior experience in translational research and/or early clinical development preferred but not required.
  • Proven track record in clinical care of patient populations or management of clinical problem-solving.