Vice President Clinical Development - South San Francisco, CA | Biospace
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Vice President Clinical Development

NGM Biopharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
12/2/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Biostatistics, Development, Pharmaceutical, Preclinical, Vice President, VP,

Job Description

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

Requirements

•   MD is required, although an MD / PhD would be desirable
•   Fifteen plus years of pharmaceutical development experience (oncology preferred)
•   Demonstrated ability to lead and manage teams
•   Excellent organizational and time management skills with superior attention to detail, ability to lead and manage multiple complex programs
•   Experience with US and European regulatory agency submissions/interactions
•   Excellent written and oral communication skills
•   Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies
•   Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships