Clinical Director; Principal Scientist), Translational Medicine, Immunology

Job Overview

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Immunology Discovery Sciences and late‑stage Immunology Clinical Research. The role focuses on Immunology within the Research Division. The Principal Scientist (Medical Director level) must have a strong background in basic and/or clinical translational research and a desire to work collaboratively across therapeutic areas.

• Lead the early clinical development strategy for novel therapy programs from preclinical candidate approval through clinical pharmacology testing (Phase
  1) and clinical proof‑of‑concept (Phase
  2).
• Develop biomarker strategies with cross‑functional teams to provide a line of sight from first‑in‑human studies through clinical proof‑of‑concept, including experimental medicine studies to establish and/or validate biomarker platforms.
• Contribute to identification of novel targets by partnering with discovery research teams and execute clinical studies to evaluate relevance to human disease, justifying investment in clinical development programs.
• Develop and execute clinical pharmacology strategies to support later stages of development from proof‑of‑concept (Phase
  2) through worldwide marketing application.

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy.
• Develop and execute 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 phases I‑IV.
• Develop and execute 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 design of preclinical and/or clinical pharmacology experiments.
• Ensure safe and timely execution of Phase I studies; collaborate with internal and external clinical study support staff and scientists.
• Provide clinical pharmacology support for programs through worldwide marketing application filing, including supportive registration documents and presentations.
• Provide clear, timely communication and interpretation of study results to governance, experts, and review committees.
• Contribute to assessment of internal and external opportunities identified by business development and licensing.
• Interface broadly with key functions across the organization throughout research sites worldwide.

• 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, and ability to function in a team environment.

• Clinical board certification or eligibility.
• Prior experience in translational research and/or early clinical development.
• Proven track record in clinical care of patient populations or management of clinical problem‑solving.

• Clinical development
• Clinical judgment
• Clinical research
• Clinical studies
• Clinical trials
• Clinical trial support
• Cross‑functional teamwork
• Early clinical development
• Immunology
• Intellectual curiosity
• Translational medicine
• Translational research

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