Director - Clinical Operations - Fremont, CA | Biospace
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Director - Clinical Operations

Verseon Corporation

Location:
Fremont, CA
Posted Date:
10/10/2016
Position Type:
Full time
Job Code:
94538
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Cancer, Cardiovascular, Clinical Operations, Clinical Research, Clinical Scientist, Clinical Trial, Clinical Trial Manager, Director, Manager, Oncology, Ophthalmology, Pharmaceutical, PhD, Regulatory Affairs,

Job Description

•   Do you want to join a team that is developing technologies that will shape the future of drug discovery?

•   Would you like an environment where you could make a major impact on a critically important industry?

•   Would you like the opportunity to do things differently instead of just following tradition?

Description:
We are seeking the right person to join the Verseon team to lead our clinical development efforts.  This is an opportunity to build a world-class clinical organization from the ground up that sets the standard for efficiency and results. The Director will have responsibilities ranging from evaluating clinical trial providers to being the main point of contact for domestic and international regulatory agencies. The right person will bring new ideas to improve on traditional clinical trials processes and methods and is not afraid to question convention.

Responsibilities:

•   Designing and implementing clinical research projects; managing clinical CRO vendors; building relationships with clinical advisory board members; establishing and maintaining contact with regulatory authorities; and preparation of regulatory briefing documents.

•   Managing the development of protocols, study-related documents, study manuals, and budgets.

•   Key role in negotiating site contracts and visiting sites to ensure progress.

•   Reviewing clinical data and assisting in the preparation of interim study analyses, annual reports, and clinical study reports.

•   Responsible for all aspects of IND and NDA submissions (and/or country-specific equivalents).

Requirements

•   PhD. in relevant scientific discipline and/or MD with at least five years of research experience.

•   10+ years of industry experience in the managing of clinical trials

•   Thorough knowledge of GCP, ICH, FDA  and EMA regulations

•   Strong organizational skills, an attention to detail, and ability to multi-task effectively

•   Strong written and verbal communication and interpersonal skills