Senior Director, Clinical Pharmacology
Ladders · Redwood City, CA · 1 mo ago
On-siteAnalyst$244k–$305k/yrFull-time
Responsibilities
- Provide strategic insight and leadership in Clinical Pharmacology
- Author technical and regulatory documents for clinical milestones including IND
- Utilize quantitative modeling to determine RP2D for pivotal studies
- Support IND-enabling assets in collaboration with DMPK and Toxicology
- Design First-In-Human studies with Clinical Development
- Conduct and report on studies such as hADME and Food Effects
- Engage with CROs for clinical pharmacology activities
Qualifications
- Ph.D. or Pharm.D (with Fellowship) in Pharmaceutical Sciences
- 8+ years experience in Clinical Pharmacology
- Experience with small molecules in oncology drug development
- Knowledgeable about FDA's Project Optimus guidance
- Familiarity with regulatory standards for clinical pharmacology
- Hands-on experience using WinNonlin and conducting Clin Pharm study designs
- Strong understanding of DMPK, CMC, and Toxicology
- Excellent communication skills with the ability to explain complex concepts simply
Benefits
- Competitive cash compensation and robust equity awards
- Strong benefits package including health care and wellness programs
- Significant opportunities for learning and development