Job Description
The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories is seeking a curious and collaborative Director to support our rapidly expanding ophthalmology pipeline. This position can be located in West Point, PA, Rahway, NJ, San Francisco or Boston.
As a director, you will serve as an expert QP2 representative on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for ophthalmologic disorders. You will work on the discovery and development of small molecules, biologics and non-traditional therapeutics like peptides. The Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. The Director should demonstrate outstanding leadership and communication skills and should work independently with minimal supervision. Within QP2, you have a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world’s most research-intensive biopharmaceutical companies.
Responsibilities:
Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within and across development programs and/or departments, to inform and optimize drug discovery and all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions.
Represent QP2 on ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio.
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 discovery and development teams.
Collaborate with other functional areas, as well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data.
Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.
Work closely with pharmacometrics team members and provide input related to analysis and reporting of modeling activities.
Mentor or supervise early career scientists to grow their skill sets to perform project related duties.
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) OR (an MS or equivalent degree with at least 11 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia.
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field.
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.
Direct experience in regulatory interactions.
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists.
Knowledge in modeling of complex therapeutics.
Flexibility to react rapidly to changing situations/environment.
Knowledge in ophthalmology and/or cardiometabolic clinical drug development programs.
Knowledge in modeling of complex ophthalmology therapeutics.
Preferred:
Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix, etc.)
Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics.
Experience with modeling programming language(s) (e.g. R, NONMEM, Phoenix, or other similar packages).
Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Company, we’re inventing for life.
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