Associate Director, Clinical Pharmacology And Pharmacometrics (Cpp)

Johnson & Johnson is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) located in Spring House, PA or Raritan, NJ.

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/ .

The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical Pharmacology & Pharmacometrics (CPP) will apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (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 Associate Director will be responsible 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 partners within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The CPP leader can independently complete 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.

Key Responsibilities:

• Devise 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 patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.

• Translate quantitative knowledge into strategic opportunities with key partners 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.

• Plan, summarize and interpret the results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.

• Prepare and deliver scientifically robust and efficient clinical pharmacology strategies for development candidates.

• Carry out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

• Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches.

• Manage and/or supervise operational elements of CPP studies.

• 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 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).

• Participate in the evaluation of potential business development opportunities.

• Stay abreast 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.

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

• Apply appropriate regulatory (eg: FDA, EMA, PMDA, ICH etc) guidelines in the design of clinical development plans and studies.

• Apply relevant technical trainings/findings to daily responsibilities, with focus of opportunistic deliver of value/impact.

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

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