Telecommute Clinical Pharmacology Director

Job ID: Available for Members

Location: Nationwide

Compensation: Salary

Posted: Wednesday, March 14, 2018

Job Category: Business Operations, Consulting, Healthcare

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Senior Level

Education Level: Masters

Additional Information: Benefits Available

Job Summary

A pharmaceutical company is in need of a Telecommute Clinical Pharmacology Director.

Core Responsibilities of this position include:

  • Providing subject matter expertise to support the continued clinical development of the Company's lead candidate molecules
  • Providing subject matter expertise in pharmacokinetics data analysis, interpretation and risk assessment
  • Effectively communicating clinical project updates to the Executive Leadership Team

Skills and Requirements Include:

  • Must be able to attend face-to-face meetings
  • PhD in Pharmacology or Pharmaceutical Sciences or related Sciences or equivalent combination of education and applicable job experience; MD or Pharm. D with relevant experience will be considered
  • Minimum of 8 years of relevant experience in the pharmaceutical or biotechnology industry
  • Extensive experience with regulatory requirements, preparation of the clinical pharmacology sections of NDAs, BLAs, understanding of FDA regulations, GCP and/ SOPs in clinical research within a pharmaceutical or biotech environment or relevant Clinical pharmacology expertise, particularly for study design and data interpretation, risk assessment necessary for preparation and filing of INDs, original and supplemental NDAs
  • Experience interacting with the FDA and/or EMA on INDs, NDAs, BLAs, and development programs
  • All other requirements listed by the company