Job Search Results - Biospace
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Ardelyx Inc.
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1/28/2016
Ardelyx Inc.
Fremont, CA

This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and...

1/28/2016
Ardelyx Inc.
Fremont, CA

MAJOR DUTIES AND RESPONSIBILITIES • Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory...

1/28/2016
Ardelyx Inc.
Fremont, CA

MAJOR DUTIES AND RESPONSIBILITIES • Provide strategic and operational statistical expertise for research through late stage clinical development • Participate in vendor evaluation/selection and manage vendors • Instruct and lead Biometrics function...

1/28/2016
Ardelyx Inc.
Fremont, CA

Manage and direct the company’s global regulatory submissions including both US (INDs, NDAs) and ex-US (CTAs, MAA) filings working with internal functional groups, CROS, and consultants. The incumbent must be well-versed in FDA and ICH regulations...

1/27/2016
Ardelyx Inc.
Fremont, CA

PURPOSE OF THE JOB Seeking a highly motivated chemist to join the medicinal chemistry group, engaging in discovery research that rapidly advance from early stage to late development. MAJOR DUTIES AND RESPONSIBILITIES • Synthesis of novel bioactive...