Medical Director - South San Francisco, CA | Biospace
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Medical Director

Kezar Life Sciences

Location:
South San Francisco, CA
Posted Date:
7/25/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Kezar Life Sciences is well-funded clinical stage biotechnology company based in South San Francisco.  We are focused on the discovery and development of small molecule therapeutics to target autoimmunity and cancer based on protein homeostasis biology. Our lead project is KZR-616, a first in class, selective inhibitor of the immunoproteasome under development in rheumatic diseases and other autoimmune disorders.  KZR-616 builds on over a decade of preclinical research on the role of the immunoproteasome in inflammation and immune responses. Phase 1 studies in healthy volunteers have been completed and clinical studies in multiple rheumatic indications will begin in late 2017.  Kezar is developing KZR-616 as a potentially transformative medicine for patients in unmet and under-met indications including (initially) SLE, lupus nephritis, idiopathic inflammatory myopathies, and vasculitis, though multiple additional autoimmune disorders may be targeted for development over time.
We are looking for a Medical Director to lead clinical development of KZR-616 in multiple autoimmune diseases.  Major responsibilities will include the following:
•   Implement clinical development in multiple autoimmune indications from Phase 1 to registration
•   Design and draft clinical trial protocol synopses, protocols and amendments
•   Partner with Clinical Operations to provide leadership and direction to protocol implementation including site identification, leading investigators' meetings, and corresponding with sites
•   Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
•   Monitor clinical trials including the oversight of all aspects of trial conduct and safety
•   Establish and maintain relationships with clinical trial investigators, KOL’s and clinical advisors through independent collaborations, clinical advisory boards, and scientific meetings
•   Support data analysis and assembly of data for clinical study reports, abstracts, presentations, and manuscripts
•   Provide clinical leadership in regulatory interactions including submissions, meetings, and responses to regulatory feedback
•   Assist in business and corporate development initiatives including partnership and fund-raising efforts

Requirements

•   MD or MD/PhD
•   3+ years of industry experience in rheumatology, internal medicine, nephrology, or hematology clinical trials
•   Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team  
•   Demonstrated independence, initiative and the ability to work well in a fast-paced environment  
•   Flexibility for travel of approximately 25 - 50% including visits to investigative sites, regulatory agencies, and major conferences