Vice president of Clinical Developement - Palo Alto, CA | Biospace
Get Our FREE Industry eNewsletter

Vice president of Clinical Developement

BioInspire Technologies

Location:
Palo Alto, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
94303
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

We are a start-up company with an exciting and highly innovative medical device- combination product. We are looking for energetic, ambitious team members to join us in our efforts to bring our product to commercialization.

Responsibilities:

•   Responsible for the overall strategic and operational aspects of BioInspire’s clinical program
•   Define development strategies including identifying clinical indications to allow for fast approvals of BioInspire products
•   In collaboration with regulatory, prepare submissions and interact with regulatory agencies
•   Establish and develop relationships with physicians and KOLs
•   Provide leadership in clinical operations and implementation of clinical programs
•   Responsible for collection, analysis, review and publication of clinical studies
•   Support business development in identifying and pursuing new clinical indications
•   Recruit and hire staff for the company’s clinical organization

Requirements

•   MD or PhD with at least 15 years of biotechnology/pharmaceutical industry with experience and success in the development of FDA-approved clinical programs
•   Proven track record in successful clinical trial design and implementation
•   Strong history of regulatory interaction, particularly FDA
•   A thorough knowledge of regulatory requirements
•   Experience with both early and late stage clinical trials
•   Track record of publications
•   Track record in building successful clinical organizations
•   Experience in upper respiratory/allergy/ Ear Nose Throat clinical indications is strongly preferred
•   Strong communication and presentation skills as well as excellent writing skills
•   Strong interpersonal skills
•   Strong analytical and problem solving skills