RESPONSIBILITIES

Directs human clinical trials, phases I and II (Proof of Concept) for Neuroscience products under development. Leads the investigative medicine function for Phase I and early Phase II Neuroscience trials, including leading the team of professionals who design and perform small studies designed to understand target engagement and proof of mechanism/concept. Manages a matrix team including PhDs, Pharmacokineticists, and Clinical Scientists in the planning, execution, and interpretation of clinical trials and research and the data collection activities.

Assists in the interpretation of clinical pharmacology profiling for Phase I and early Phase II Neuroscience clinical trials, and the design of drug to drug interaction, age and gender, renal and hepatic impairment, food effect, and ADME Absorption Distribution Metabolic Excretion studies on healthy volunteers. Designs experimental protocols and patient record forms. Prepares protocols and conducts clinical studies of products that have been determined to satisfy medical need and or offer a commercial potential. Serves as medical scientific expert to marketing or research project teams and government regulatory agencies.

Establishes conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug candidates. Monitors and or interprets results of Phase I and II investigations in preparation for new drug application. Coordinates and develops reporting information for reports submitted to the FDA. Participates as Discovery Medicine expert in licensing and acquisition evaluations.

REQUIREMENTS

Board Certified MD or MD PhD. 2 to 5 years clinical experience gained through industry experience. Management experience in pharmaceutical or biotech industry. Experience leading representatives on one or more drug development teams in cross functional matrix teams, e.g., ECRT, EDT, FDT, DWG. Project management and or strategy experience in drug development with multiple compounds in various stages of development.

RESPONSIBILITIES

REQUIREMENTS

LOCALE

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