Director Quantitative Pharmacology Pharmacometrics
Director Quantitative Pharmacology Pharmacometrics
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Job Description
Job Description
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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 preIND IND phase13 PK PK/PD and regulatory submissions.
In this position you will lead analysis and reporting of pharmacometrics studies. You will provide input into all phases of drug development including but not limited to dose finding dose optimization exposureresponse and pediatric development. The Director of Quantitative Pharmacology Pharmacometrics loosely interacts with nonclinical and bioanalytical team members for design and of firstinhuman 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 preIND and early phase assets.
- Lead pharmacometrics activities related to study design protocol development study 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 investigators 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 vivoin vitro correlations and biowaivers for pre and postapproval 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 modelbased drug development strategies for ongoing projects.
Minimum Qualifications:
- PhD in pharmacometrics (or a related area such as pharmacokinetics clinical pharmacology pharmacology or a related area) with a minimum of 810 years of industry experience in these areas.
- Strong technical and hands on experience in population PK and PK/PD modeling.
- Indepth knowledge of pharmacometrics population PK and PK/PD modeling clinical pharmacology drug metabolism biopharmaceutics and bioanalytical chemistry.
- Hands PK and PK/PD analysis and statistical analysis using NonMEM Phoenix NLME Julia R etc.
- Excellent working knowledge of phase I clinical operations drug development multiregion regulatory requirements.
- Good working knowledge of formulation development drug development and clinical development.
- Current awareness of the latest developments in clinical pharmacology and guidance documents.
- Must be able to apply scientific knowledge (in the areas specified above) to further the companys products anticipate and identify core problems apply insightful analysis and solve problems effectively.
- Strong technical and hands on experience related to pharmacometrics population PK and PK/PD modeling.
Required Experience:
Director
Employment Type
Full-Time
