Senior Principal Scientist, Immunology Clinical Pharmacology

Johnson and Johnson is currently seeking a Senior Principal Scientist, Immunology Clinical Pharmacology located in Spring House, PA; Raritan, NJ; Titusville, NJ; OR Beerse, Belgium.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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The Senior Principal Scientist, Immunology within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote Clinical Pharmacology expertise including the design of Clinical Pharmacology components of simple and complex clinical studies, pharmacokinetic (PK) and pharmacodynamic (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The Senior Principal Scientist CPP Leader independently executes the day to day operations for the Clinical Pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.

Primary responsibilities:

• Devise the clinical pharmacology and MIDD strategy via application of quantitative methods to integrate knowledge of nonclinical data, PK, PD, disease states, competitive landscape, etc. to influence go/no go decisions, dose and dose regimen selection, and optimize study designs throughout drug development. Translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-informed drug development principles.

• Plan, perform, and/or provide oversight for appropriate analyses (e.g., non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data) of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.

• Responsible for planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.

• Develop key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape

• Define regulatory strategy for CP and prepare CP contributions to regulatory documents. Represent CP in relevant external regulatory meetings.

• Participate in the evaluation of potential business development opportunities.

• Stay abreast of clinical pharmacology, MIDD, analysis methodology and overall drug development process, including regulatory guidance, and modelling and simulation methods by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) .

• Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.

• Apply appropriate regulatory guidelines in the design of clinical development plans and studies.

• Foster working environment that promotes collaboration, innovation, and creativity.

• Assist in process improvement initiatives and SOP development where applicable.