|Zosano Pharma, Inc. is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. Zosano Pharma is built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common commitment to work toward achieving the Company? goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success.
The Associate Director of 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 be the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. In addition, the Associate Director of Clinical Operations will serve as mentor and direct supervisor to more junior clinical operations staff as they come on board at Zosano.
In conjunction with the Chief Medical Officer, the Director of 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 and selection 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
Assist in the 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)
Assist in preparation and updates of Investigational Drug Brochures (IBs)
Preparation and management of clinical trial site budgets
Assist in preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
Assist in clinical trial report preparation and data interpretation
Assist in 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
State or Province