The Director of Clinical Pharmacology will bring deep expertise across both preclinical and clinical development, with a strong track record of success in advancing drug candidates through early development.
Requirements
- Interpret nonclinical data and translate findings into clinical pharmacology development plans
- Design and oversee early-phase clinical trials
- Collaborate with colleagues on the selection and implementation of appropriate biomarker, imaging, and pharmacodynamic endpoints
- Develop and review study protocols, statistical analysis plans, and tables, listings, and figures
- Represent Translational Sciences / Clinical Pharmacology within asset teams
- Support regulatory submissions including IND enabling packages, NDAs, MAAs, and NDSs
- Acquire and maintain knowledge of national and international regulatory guidelines
- Collaborate effectively with multidisciplinary teams to ensure alignment and integration of clinical pharmacology strategies
- Ensure compliance with GCP, ICH guidelines, and internal Standard Operating Procedures (SOPs)
- Work with the quality assurance team on SOP development, revision, and implementation
- Evaluate licensing and partnership opportunities, with a focus on clinical pharmacology aspects
Benefits
- Competitive base salary
- Discretionary bonus
- Equity awards
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance