Director, Infectious Diseases and Vaccines, Quantitative Pharmacology and Pharmacometrics

Job Description

Directors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications. Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents. Directors are expected to have or be developing expertise in several areas, including:

• Serving as an expert representative for QP2 on teams developing infectious disease or vaccine assets

• Framing critical drug development questions for optimizing model-based development

• Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings

• In partnership with key cross-functional area experts, strategically frame and progress issues related to clinical pharmacology and biopharmaceutics

• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities

The Director is a skilled quantitative drug and vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development.  They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Directors demonstrate outstanding leadership and communication skills. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug development teams.

This role will be focused on efforts in the infectious disease and vaccines therapeutic area.

Required:

• a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree with at least nine years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia

• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

• Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar)

• Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development

Preferred:

• Prior experience working in infectious diseases, including respiratory viruses

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry

• Ability to influence regulatory strategies including independently formulating and defending registration packages to support global filings

• A strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factor evaluation

• Experience in performing population PK, PKPD, or viral dynamic analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)

• Expert skills in experimental design, mathematical problem solving, critic