Location: Raritan,NJ, USA
Johnson & Johnson is recruiting for a Director, Clinical Pharmacology & Pharmacometrics (CPP) located in Raritan, NJ; Spring House, PA or La Jolla, CA.The Therapeutic Area (TA) Clinical Pharmacology Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of 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 Director, CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound including innovative ways and leads the regulatory strategy for clinical pharmacology. As CPP Leader on the Compound Development Teams (CDT), the Director works in collaboration with various partners within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics) and provides recommendations that impact the drug development decisions for a program in addition to independently complete the day to day operations for the clinical pharmacology aspects of one or more programs within a disease area and provide management directly or indirectly to junior CPP leaders. The Director CPP leader contributes to the strategic direction of CPP department and/or TA.Key Responsibilities:Responsible for the planning and execution of 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 of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design and overall drug development strategy.Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.Accountable for planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates and TA strategy.Manage directly or indirectly more junior CPP colleagues.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).Stay abreast of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community.Work effectively in a matrix environment, managing CP deliverables in accordance with timelines and overall project goals.Foster working environment that promotes collaboration, innovation, and creativity.Provide and arrange training and presentations on innovative CP approaches across the R&D organization.QualificationsEducation:A minimum of a Bachelor's degree is required. An advanced degree (PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences) is preferred.Experience and Skills:Required:10+ years of experience in pharmaceutical or related fields is required.Expert knowledge and understanding of PK, PD, PK-PD, and/or Translational Medicine and their applications in model informed drug development (MIDD) is required.Excellent communication skills, leading meetings and interacting with team members, collaborators, and regulatory authorities is required.Preferred:Outstanding leadership and ability to mentor junior colleagues, exemplified through the ability to inspire others, to set a positive example by providing assistance, recognition and encouragement is preferred.Has established a strong level of expertise and scientific reputation through multiple publications and presentations is preferred.The anticipated base pay range for this position is $157,000 to $271,400. This job posting is anticipated to close on 10/16/2024.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.#J-18808-Ljbffr