What are the responsibilities and job description for the Director, Quantitative Pharmacology, Pharmacometrics position at Penfield Search Partners?
Job Description
Job Description
Contact : Alexandra Spink –
No 3rd party agencies
Job Description : As a Director, Quantitative Pharmacology, Pharmacometrics, you will play a critical role in advancing drug development by serving as the key expert on all pharmacometrics matters relating to assigned clinical projects. You will oversee all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK / PD and regulatory submissions.
In this position, you will lead analysis, execution and reporting of pharmacometrics studies. You will provide input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. The Director of Quantitative Pharmacology, Pharmacometrics loosely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies.
This position is based in Rockville, Maryland or Princeton, New Jersey. This is a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options will be considered for US candidates.
Responsibilities :
- Author / reviewer of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings.
- Interacts with early development and business development team members as well as external collaborators to assess / lead development and selection of pre-IND and early phase assets.
- Lead pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data.
- Conduct population PK, PK / PD analysis and modeling and simulation.
- Leads pharmacometrics team members and participate in activities related to analysis and reporting of population PK and PK / PD analyses.
- Leads pharmacometrics and modeling and simulation activities to support optimizing clinical study dose, dosing regimen and design.
- Lead development of pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator’s brochure, IND / NDA applications and pediatrics development plans.
- Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK / PD.
- Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
- Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK / PD analyses, contract requisition, SOW and approval of invoices.
- Training and mentoring of staff related to population PK and PK / PD modeling.
- Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and lead model-based drug development strategies for ongoing projects.
Minimum Qualifications :
