Summary
Well established, Mid-Sized Pharmaceutical company is looking for a Senior Director of Clinical Pharmacology to spearhead Oncology programs within early and late stages of clinical development. This person will contribute to the design, execution, planning and interpretation of Clinical Pharmacology studies. This person should be well-versed in current practices within Clinical Pharmacology, DMPK, Pharmacometrics, and bioanalytical assay. Experienced making regulatory decisions, and a demonstrated ability to conduct data-driven decisions based on pre-clinical and clinical information is a must.
*Roles and Responsibilities of the Position:
- Planning, design, execution, and interpretation of Clinical Pharmacology studies.
- Conduct pharmacokinetic and pharmacodynamic data analysis.
- Collaboration, Cross-functionally, with other departments, such as Biostats, Translational science, Pharmacovigilance and Regulatory.
- Design and develop Clinical Pharmacology submission documents for regulatory filings.
- Act as a representative of Clinical Pharmacology in regulatory interactions.
- Address inquiries from and participate in meetings with regulatory authorities.
*Required Qualifications and Background:
- PhD or PharmD with a minimum of 3 years of pharmaceutical industry experience.
- Strong Communication and project management skills are essential to work effectively with cross-functional teams
- Hands-on experience on population PK/PD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirable
- Experience in preparing regulatory submissions such as INDs or NDAs and direct drug development experience within oncology is desired but not required
- Hands-on experience on population PK/PD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirable