Associate Director, Clinical Operations Zosano Pharma
Zosano Pharma, Inc. is a specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. We have developed a user-friendly, simple, and needle-free transdermal delivery system consisting of a patch and applicator ? that is proven capable of delivering a broad range of compounds, including peptides, proteins, small molecules and vaccines. This innovative technology is enabling us to develop products with significant commercial potential both independently and in collaboration with strategic partners. We aim high. Our lofty goals are built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common vision and are committed to achieving the Company?s goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success. We are seeking individuals who want to make a mark in their profession and who are eager to grow. If you aspire to lofty goals and desire success, you?ve come to the right place. Read on?
The Associate Director, Clinical Operations will provide operational and implementation expertise to the product/project teams under the guidance of the Chief Medical Officer. He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring compliance, managing timelines, budgets and review of all clinical data. The Associate Director, Clinical Operations will serve as the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. The Associate Director will need to execute effectively as a member of a cross-functional team, leveraging players from R&D, as well as G&A, influencing and leading all clinical operations outcomes. The right candidate will have the depth of clinical research experience and regulatory knowledge necessary to make independent operational decisions and be comfortable in executing daily operational tasks.
With guidance from the Chief Medical Officer, the Associate Director, Clinical Operations will manage all aspects of clinical operations for assigned clinical trials to assure the highest standards of clinical trial execution and GCP. Activities include:
Evaluation, selection and management of CROs and other vendors for clinical trials
Oversight of clinical trial site management in conjunction with selected CRO
Oversight of clinical trial site monitoring and source documentation verification
Development of in-house operations SOPs, guidelines and systems
Lead development of the departmental budget
Assist the Chief Medical Officer in protocol design and provide advice on logistical issues
Input/prepare patient informed consent document (ICDs)
Preparation and updates of Investigational Drug Brochures (IBs)
Preparation and management of clinical trial site budgets
Preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
Guide clinical trial report preparation and data interpretation
Preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met
Oversee data clarification process as needed in conjunction with selected CRO and insure database lock according to agreed timeline
Bachelor degree in a scientific discipline; advanced degree preferred.
8 or more years of drug development experience, at least 4 of which in clinical operations in a pharmaceutical or biotech company
Strong working knowledge of the drug development process, with experience in clinical studies from Phase 1 to Phase 3
In-depth knowledge of ICH/GCP guidelines and FDA regulations.
Ability to work independently
Excellent oral and written communication skills
||34790 Ardentech Court |
Fremont, CA 94555