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
