September 10, 2016

Vice President Clinical Development

NGM Biopharmaceuticals, Inc. - South San Francisco, CA

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Job Description

NGM Biopharmaceuticals is seeking an accomplished, highly motivated and detail oriented clinical development leader for our clinical development organization, currently in the cardiometabolic and oncology therapeutic areas. This person will be responsible for clinical operations, regulatory, clinical development and oversight of the strategic growth of the development capabilities of the company (pharmacovigilance, biostatistics, etc.). The VP of Clinical Development will report directly to the CMO and be responsible for the clinical strategy of the development programs, as well as the design and implementation of international clinical studies, oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including Research, Pre-Clinical Development, Translational Science and CMC, as well as the BOD and our Scientific Advisory Board.

Essential Functions

Devise strategy for, develop and implement clinical studies for novel investigational medicines (monoclonal antibodies and proteins)
Oversee the execution of all clinical studies
Oversee the growth of the clinical development organization to meet the needs of the growing clinical opportunities
Work closely with other functional areas within R&D (clinical pharmacology, preclinical) and external consultants/vendors to facilitate the execution of clinical trials and programs
Oversee regulatory strategy in conjunction with project team members, regulatory affairs and senior management
Provide clinical/scientific input during the development, execution and completion of clinical trials
Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results
Monitor clinical trials for safety to insure timely reporting of safety signals
Lead preparation of clinical portions of all relevant regulatory filings and review sections from other functional areas
Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans