Looking to have a broader impact on drug development strategies and approvals by applying your knowledge and skills in pharmacometrics, but don’t know how? Our client manages consortia of industry, clinical, patient advocacy and regulatory stakeholders intent on accelerating safe, effective drug approvals for a variety of disease areas. The Director of Pharmaceutics plays a key role leading a team and interacting with specific consortia and working groups which have agreed to share data for a common goal. In such consortia of diverse stakeholders, data-based evidence for improved clinical outcome measurements, better safety or efficacy biomarkers, and digital disease models have been generated and led to improved FDA guidances and faster drug approvals for suffering patients. As Director of Pharmacometrics, https://www.linkedin.com/jobs/view/3582188432/ you will lead the Pharmacometrics team within Quantitative Medicine. You will work closely with clinicians, statisticians, and other scientists primarily be responsible for the clinical pharmacology and modeling and simulation components of development plans. This is an opportunity to work remotely with a first-class team and to have a broader impact than possible within a single biopharma company. It is a hands-on data role as well as a team leadership role. Also a full-time, permanent employee position with a stable and growing company.
MAIN DUTIES:
- Plan and direct clinical pharmacology and modeling and simulation components of programs.
- Work with multifunctional internal and external teams to design, deliver and report the assigned clinical pharmacology and modeling and simulation tasks
- Oversee the development and implementation of modeling and simulation plans based on agreed upon best practices (i.e. model-based drug development).
- Oversee use of quantitative methods to integrate knowledge of PK, PD, patient characteristics, and disease states to inform optimization of doses, dosage regimens and study designs.
- Ensure that results of data analyses (with respect to their impact on development of quantitative drug development tools) are appropriately summarized and interpreted.
- Prepare scientific summaries and reports which will be used for regulatory submissions and publications.
- Provide quantitative medicine, clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.
EDUCATION AND EXPERIENCE
- A PharmD or PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, engineering, or related field, typically 7+ years of experience
- Prior experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management, or regulatory affairs in the pharmaceutical industry and/or FDA/EMA) required.
- Proficiency in NONMEM and R coding required. Additional experience with SIMCYP, Phoenix, WinNonLin, SAS, Monolix, Gastroplus, etc. preferred.
- Strong understanding of PK principles, PK/PD and pharmacology related to quantitative drug development platforms.
- Proficient in modeling (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, etc.)
- Knowledge of phase I-III studies (linear and non-linear mixed-effects models; parametric survival analyses; joint modeling for time-matched data; and model-based meta-analyses
- Excellent English communication and interpersonal skills.
PREFERRED
- Knowledge and experience in multiple therapeutic and/or functional areas across range of development phases
Must be N. American based. Company is willing to sponsor visas or transfer visa sponsorship for US/Canada residents.
To apply for this position, confidentially email us here.