Senior Director, Clinical Pharmacology

Job Description

Lead the clinical pharmacology strategy and development in line with program objectives and regulatory guidelines for small molecule therapeutics. Collaborate with DMPK, clinical research, and CMC teams to define clinical pharmacology studies crucial for NDA and drug labeling. Design and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies. Provide clinical pharmacology expertise and partner with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis. Oversee the selection of Phase 1 CROs. Accountable for analyzing PK and PK/PD data. Participate in clinical study protocols and regulatory submissions. Represent clinical pharmacology in regulatory meetings. Focus on strategic planning and team leadership.

Qualifications

1. Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, or related field. 2. 10+ years of industry experience in clinical pharmacology. 3. Minimum of 10 years of supervisory experience. 4. 13 years of overall professional experience. 5. Familiarity with clinical drug development stages. 6. Ability to develop clinical pharmacology strategies. 7. Expertise in FIH, Ph II/III dose selection, drug-drug interactions. 8. Experience in INDs, CTAs, NDAs, and MAAs preparation. 9. Strong vendor management skills. 10. Proficiency in PK and PK/PD Modeling software. 11. Strong communication and problem-solving skills. 12. Ability to influence business leaders.

Benefits

- Discretionary annual target bonus - Stock options - ESPP - 401k match - Comprehensive health insurance plans - 20 days of PTO - 10 paid holidays - Winter company shutdown