Director, Quantitative Pharmacology and Pharmacometrics Immunology

Job DescriptionPosition Description:Director, Quantitative Pharmacology and Pharmacometrics Immunology (R5)The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Research & Development Division in West Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding immunology pipeline. (Position can be available in Boston, MA and South San Francisco, CA)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 immunologic disorders. More specifically, you will apply your quantitative skills independently with minimal supervision to develop and implement translational PK/PD strategies, characterize clinical population pharmacokinetics and pharmacodynamics of biologics, small molecules and non-traditional therapeutics like peptides, novel biological constructs and others, perform clinical trial simulations, comparator modeling and other model-based analyses to inform dose selection and schedule, clinical trial design and go/no-go decisions. You will apply your expertise to frame critical drug development questions to optimize drug development using model-based approaches and influence cross-functional teams to adopt such strategies. Finally, you maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.The Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. You develop strategies for quantitative analyses and commensurate experiments/trials within and across development programs and/or departments. The Director should demonstrate outstanding leadership and communication skills. The Director collaborates with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed framework to impact strategies and decisions of drug development teams. Finally, the Director mentors or supervises early career scientists to grow their skill-sets to perform tasks described above.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.Position Qualifications :Education Minimum Requirement:Ph.D. or equivalent degree with at least seven years of experience ORPharmD or equivalent degree with at least nine years of experience ORMS 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 or academia.Required Experience and Skills:Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, computational biology, 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.Experience with application of modeling in projects.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 scientifically supervise the work of other scientists.Knowledge of clinical autoimmune drug development.Preferred Experience and Skills: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 pharmacometric software (e.g. NONMEM, Monolix, Phoenix, or similar platforms).Experience with mechanistic modeling frameworks such as PBPK or QSP.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.

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