Overview:
The Clinical Pharmacology, Director role will effectively provide support for the design, execution, interpretation and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will participate in the selection of Phase 1 CROs for clinical pharmacology studies. This function will provide support in characterizing the clinical pharmacology profile of a given compound with an emphasis on dose and regimen selection for Phase 1, 2 and 3 studies. This individual will serve as clinical pharmacology representative on studies and project teams, and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators. The Clinical Pharmacology, Associate Director may provide oversight and also be responsible for the pharmacometric related analyses and activities in support of the clinical pharmacology profile of a compound.
Responsibilities:
- Provide support in designing and interpreting Phase 1 as well as other clinical studies that have PK or PK/PD data.
- Perform or supervise non-compartmental and population PK or PK/PD analyses.
- Contribute to clinical study protocols and reports.
- Contribute to the selection of Phase 1 CROs.
- Participate in dosing selection for Phase 1 and possible Phase 2 and 3 clinical studies.
- Interact with pharmacologists, toxicologists, medical directors, and regulatory affairs personnel within SKLSI for the timely completion of clinical studies and regulatory filings.
- Represent the Clinical Pharmacology group on multi-disciplinary study teams with a potential to represent the function on project teams.
- Contribute to regulatory documents (INDs, NDAs, and IBs) as needed.
Qualifications:
Education:
- PharmD or PhD degree in Pharmaceutical Sciences or related discipline.
Experience:
- Preferably up to 8 years of industry experience with a background in PK and PD.
- Previous experience in leading clinical pharmacology programs.
- Highly skilled in non-compartmental analyses.
- Preferably knowledge of NONMEM and R.
- Excellent writing and verbal communication skills.
- Ability to work in a matrix environment and with different leadership styles.