Clinical Science Associate Director

Location
Dale City, CA
Posted
Oct 03, 2018
Discipline
Clinical, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

Requirements:

  • Ph.D or Pharm.D. preferred.  Other education with experience considered.
  • Immunology clinical experience required; Oncology experience preferred
  • 4+ years in a clinical position in the pharmaceutical industry with deep knowledge of all phases the clinical development process
  • Pre-IND, translational, IND submission to Phase 1 experience preferred
  • Experience with biologics preferred
  • Proficient in medical writing (e.g protocols, IBs) 
  • Experience in data interpretation and analysis and use of software to do so (e.g. pivot tables, Spotfire, or Medidata, etc)
  • Excellent ability to understand and pick up clinical science / research from a medical, regulatory, and marketing perspective
  • Maturity in terms of interactions with others internally and externally and maintaining confidential information. 
  • Proficiency in medical communications via writing and presentations

Description:

  • Write and edit clinical materials such as protocols, the clinical part of regulatory submissions, IBs etc. 
  • Stay abreast of the scientific literature for specific clinical indications and competitive drugs.  Stay abreast of open data from ongoing company studies. 
  • Help represent clinical research on project core teams.
  • Interact with regulatory to shape clinical strategy and regulatory agency responses
  • Work with Clinical Operations to support ongoing studies and support datalocks