Principal Scientist, Translational Medicine, Neuroscience

• Work with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets

• Design preclinical and clinical experiments to validate targets and/or pathways and leverage this work for development of novel therapeutics

• Collaborate with discovery scientists, pharmacologists, toxicologists, and other specialists to advance therapeutics from preclinical into clinical development

• Lead early development teams and collaborate with internal and external staff across discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations

• Develop and execute clinical pharmacology studies in Phases I–IV, including formulation or device changes, drug-drug interaction studies, and special-population studies

• Provide early-phase and clinical pharmacology support through regulatory filing, including preparation of supporting documents and presentations

• Develop and execute studies to validate clinical biomarkers using blood/tissue sampling, imaging, electrophysiological methods, wearable devices, and behavioral responses

• Assess internal and external partnership opportunities using clinical and scientific expertise

• Engage with scientific and academic thought leaders through consultations, posters, publications, and conference attendance/presentations

• Work with key functions across the company at research sites around the world

• Contribute to novel target identification and validation with Discovery Sciences

• Lead early clinical development strategy from preclinical development through Phase 1 and Phase 2 proof-of-concept studies

• Develop biomarker strategies and experimental medicine studies from First-in-Human studies through clinical Proof-of-Concept

• Develop and execute clinical pharmacology strategies supporting later development and worldwide regulatory applications

• Doctoral degree: MD or MD/PhD (or international equivalent) required
• Experience in biomedical research, with a demonstrated record of scientific scholarship and achievement including scientific publications
• Strong interpersonal, writing, and presentation skills
• Ability to function in a team environment
• Experience in clinical medicine including completion or anticipated completion of residency training is required
• Training and clinical board certification or eligibility in Neurology, Psychiatry or a related discipline involving care of neurologic/psychiatric diseases preferred
• Experience as an academic faculty member preferred
• Prior experience in translational research and/or early clinical development helpful but not required
• Must reside in the United States or Puerto Rico
• Visa sponsorship:
  No
• 10% travel required

Demonstrates expertise in clinical pharmacology and early clinical development, with a focus on designing and executing studies that validate novel therapeutic targets and biomarkers. Engages effectively with cross-functional teams and thought leaders to advance drug development from preclinical to clinical phases.

• Clinical Pharmacology Studies
• Early Clinical Development Strategy
• Biomarker Validation
• Interpersonal Skills
• Scientific Publications

• Clinical Trial Design
• Translational Research
• Drug-Drug Interaction Studies
• Experimental Medicine Studies
• Regulatory Filing Support
• Blood/Tissue Sampling
• Imaging Techniques
• Electrophysiological Methods
• Wearable Devices
• Behavioral Responses

• Team Collaboration
• Writing Skills
• Presentation Skills

• Doctoral Degree (MD or MD/PhD)
• Clinical Board Certification in Neurology or Psychiatry

• Biomedical Research
• Novel Therapeutics
• Clinical Development
• Proof-of-Concept Studies
• Regulatory Affairs
• Global Clinical Trials Operations
• Discovery Sciences
• Scientific Scholarship
• Academic Faculty Experience
• Neurologic/Psychiatric Diseases