Prin. Scientist, Clinical Research

Principal Scientist (Director) in Translational Medicine - Oncology

Translational Medicine Is Specifically Responsible For:

• Leadership of early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Phase 1 (clinical pharmacology testing) and Phase 2 (clinical proof-of-concept).
• Development of biomarker strategies with cross-functional teams, providing line-of-sight from First-in-Human through Phase 2; includes Experimental Medicine to establish/validate biomarker platforms.
• Partnering with discovery research to bring clinical perspective to early target identification/validation and executing clinical studies to evaluate target relevance to human disease.
• Development and execution of clinical pharmacology strategies to support Phase 2 through worldwide marketing application.

Primary Responsibilities:

• Key member of an early development team; lead the design and execution of early clinical development strategy.
• Author and execute early clinical and biomarker plans (Lead Optimization), early clinical development plans (Preclinical Candidate molecules), and clinical pharmacology studies (Phases I-IV).
• Validate clinical platforms using established/novel biomarkers (including imaging, electrophysiological, and behavioral responses).
• Provide clinical expertise for novel target identification/validation, including preclinical/clinical pharmacology experiments.
• Safe and timely execution of Phase I studies and close collaboration with internal/external study support functions.
• Provide clinical pharmacology support through worldwide marketing application filings.
• Communicate and interpret study results to governance/experts and development review committees.
• Assess internal/external opportunities identified by Business Development and Licensing.
• Interface broadly with key functions across research sites.

Education:

• MD/PhD or MD

Required:

• Clinical experience and/or basic science background in internal medicine, pathology and/or oncology.
• Demonstrated scientific scholarship/achievement; oncology preferred.
• Strong interpersonal, writing, and presentation skills; team-oriented.
• Clinical board certification preferred.

Preferred:

• Prior translational research and/or early clinical development experience.

Required skills (examples):

• Clinical development/research, early clinical development, ethical compliance/standards, internal medicine, pharmaceutical development/sciences, pharmacokinetics, protocol development, scientific writing, strategic thinking, translational research.