Principal Scientist, Clinical Pharmacology & Pharmacometrics

Principal Scientist Clinical Pharmacology & Pharmacometrics

We are searching for the best talent for our Principal Scientist Clinical Pharmacology & Pharmacometrics position, to be located in Raritan, NJ;
Titusville, NJ; or Spring House, PA.

The Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology studies and/or clinical pharmacology components of clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of model-informed drug development (MIDD) principles across all stages of drug development. The Senior Principal Scientist CP Leader develops compound-specific Clinical Pharmacology strategies for supported programs, including interactions with regulatory agencies, and serves as the CP Leader on cross-functional compound teams and within CPP (e.g., Pharmacometrics).

The Senior Principal Scientist independently leads the day-to-day clinical pharmacology activities for programs within the Portfolio and Lifecycle Management (PALM) organization, focused on established brands and post-approval development opportunities.

You will be responsible for:

• Devising the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
  
  Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD analyses and reporting.
• Devising clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines.
• Managing and/or supervising elements of CPP studies.
• Developing key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape.
• Defining regulatory strategy for CPP and prepare CP contributions to regulatory documents including IBs, IND's, briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participating in the evaluation of potential business development opportunities.
• Contributing to the knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• Working effectively in team environments, managing CP deliverables in accordance with timelines and overall project goals.

Qualifications / Requirements:

• PhD, or equivalent degree in Pharmaceutical…