Director, Clinical Pharmacology
About The Position
Serve as the lead clinical pharmacologist on the project team, accountable for clinical pharmacology deliverables, providing subject matter expertise on PK/PD and quantitative pharmacology. Play a pivotal role in planning and executing clinical pharmacology activities to support development programs. Drive utilization of model-based drug development approach for human PK prediction, dose and dosing regimen selection and optimization, collaborating closely with cross functional colleagues. Oversee and/or perform PK/PD data analyses and contribute to the interpretation of study results through all phases of clinical development. Lead preparation and review of clinical pharmacology sections of study protocols, reports, investigators' brochures and regulatory filings (IND’s, BLA’s, etc.), and respond to regulatory inquiries related to clinical pharmacology. Provide oversight to vendors and consultants to ensure timely delivery of high-quality data and reports to support go/no-go decisions and dosing strategy. Assure the implementation and adherence to SOPs, GXPs, and regulatory standards in clinical pharmacology programs.
Requirements
- PhD in pharmaceutical sciences, pharmacology with a focus on pharmacokinetics and pharmacometrics.
- Strong understanding of clinical pharmacology study design, data analysis, and regulatory requirements.
- Minimum 8 years of experience in clinical pharmacology and pharmacometrics, with hands-on experience in PK data analysis.
Nice To Haves
- Prior experience in the field of ADC development is a plus.
- Experience in the Oncology therapeutic area is highly desirable.
Responsibilities
- Serve as the lead clinical pharmacologist on the project team, accountable for clinical pharmacology deliverables, providing subject matter expertise on PK/PD and quantitative pharmacology.
- Play a pivotal role in planning and executing clinical pharmacology activities to support development programs.
- Drive utilization of model-based drug development approach for human PK prediction, dose and dosing regimen selection and optimization, collaborating closely with cross functional colleagues.
- Oversee and/or perform PK/PD data analyses and contribute to the interpretation of study results through all phases of clinical development.
- Lead preparation and review of clinical pharmacology sections of study protocols, reports, investigators' brochures and regulatory filings (IND’s, BLA’s, etc.), and respond to regulatory inquiries related to clinical pharmacology.
- Provide oversight to vendors and consultants to ensure timely delivery of high-quality data and reports to support go/no-go decisions and dosing strategy.
- Assure the implementation and adherence to SOPs, GXPs, and regulatory standards in clinical pharmacology programs.
Benefits
- Competitive compensation, including base salary, performance bonus, and equity
- 100% employer-paid benefits package
- Flexible PTO; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
