Principal Scientist (Director), Translational Medicine - Infectious Diseases

We have an exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in Translational Medicine/Early Clinical Development in the Infectious Diseases Therapeutic Area. Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our discovery scientists and late-stage clinical researchers. The Infectious Diseases Therapeutic Area specifically focuses on translational and clinical development of anti-infectives, both for treatment and for prophylaxis indications. We are seeking a highly qualified individual for a position in our group. Candidates must have a strong background in basic and/or clinical translational research and a desire to work collaboratively with functional area partners across therapeutic areas and stages of development. Translational Medicine is specifically responsible for: Contributing to the identification of novel targets by partnering with Discovery Sciences to bring a clinical perspective into the earliest stages of target identification and validation, and to execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development. Leadership of the early clinical development strategy for novel therapeutic programs from the preclinical stage through Phase 1 studies of safety, tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating Proof-of-Concept and enabling Phase 3 clinical trials. Development of biomarker strategies through cross-functional teams that advance therapeutics from First-in-Human studies through clinical Proof-of-Concept. This includes experimental medicine studies to establish and/or validate biomarker platforms. Development and execution of clinical pharmacology strategies to support later stages of development, from Phase 3 through to worldwide regulatory applications. Success depends on the integrity, knowledge, imagination, creativity, skill, versatility and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.

Requirements: MD or MD/PhD Primary responsibilities for the Principal Scientist include the following: Working with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical experiments to validate targets and/or pathways, and leveraging this work for development of novel therapeutics Working with cross-functional teams including discovery scientists, pharmacologists, toxicologists, and other specialists to advance novel therapeutics from preclinical development into clinical development As a key member/leader of an early development team, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy Taking a lead role in developing and executing clinical pharmacology studies for programs in all phases (I – IV) of development, including formulation or device changes, drug-drug interaction studies, and studies in special populations Providing early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and presentations Developing and executing studies to validate established and novel clinical biomarkers, including blood/tissue sampling, imaging, electrophysiological, wearable devices, and behavioral responses to study biological activity in humans Providing clinical and scientific expertise to assess internal and external opportunities for partnership Engaging with the broader internal and external