Vice President Clinical Development 9/10/2016

NGM Biopharmaceuticals, Inc. South San Francisco, CA

Company
NGM Biopharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360788
AJE Ref #
576132987
Location
South San Francisco, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
NGM Biopharmaceuticals is seeking an accomplished, highly motivated and detail oriented clinical development leader for our clinical development organization. NGM currently concentrates in the cardiometabolic and oncology therapeutic areas. This person will be responsible for the strategic growth of the development capabilities of the company. The VP of Clinical Development will report directly to the CMO and be responsible for conceiving and implementing the clinical strategy of the development programs, as well as the design and execution of international clinical studies, oversight and interpretation of clinical trials data and 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
Manage the clinical operations, regulatory clinical development and medical affairs functions
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,translational, etc.) 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 ensure timely reporting of safety signals
Lead preparation of clinical portions of all relevant regulatory filings and review sections from other functional areas
Serve as lead medical representative with regulatory agencies
Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
Oversee clinical advisory board meetings to obtain strategic input into clinical program development