Associate Director Immunology - CPP

le contenu du travail

The Clinical Pharmacologist will provide Clinical Pharmacology (CP) expertise including, pharmacokinetics (PK), pharmacodynamics (PD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The applicant will be responsible and accountable for developing Clinical Pharmacology Development Plan (CPDP) for compounds in development. Collaborating with partners and project teams, the candidate will apply and promote Clinical Pharmacology knowledge, including that of MIDD. Independently execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs. Main Accountabilities: Provide overall compound development strategy via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. With assistance from senior members, the Scientist will translate quantitative knowledge into strategic opportunities with key partners to drive development that embodies the model-based drug development principles. Assist CPP and Pharmacometrics (PM) Leaders with modeling and simulation activities in drug development programs. Perform and/or collaborate closely for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) and POC studies). Responsible for appropriate summarization and interpretation of results of PK/PD analyses with respect to their impact on development and clinical use of drugs. Assist CPP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates. Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles. Design Phase I Clinical Pharmacology studies. Other Accountabilities & Tasks Plan, conduct, and/or provide oversight of PK and PKPD analyses and reporting. Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches. Handle and/or supervise operational elements of CPP studies. Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape; subsequently continue to collaborate closely with key functional partners to provide product differentiation strategies throughout the drug development continuum. Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, NDA / MAA submissions, bridging documents, post-approval filings, and responses to health authority questions and where appropriate represent CP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA / MAA, Advisory Committee meetings). When requested, participate in the evaluation of potential business development opportunities. Stay on top 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, speaking publicly 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 efficiently within teams, leading CP efforts in accordance with timelines and project goals. Apply appropriate regulatory (eg: FDA, EMEA, ICH etc) guidelines in the design of clinical development plans and studies. Apply relevant technical trainings/takeaways to daily responsibilities, with focus on delivering value/impact. Apply relevant technical trainings/takeaways to daily responsibilities, with focus of opportunistic deliver of value/impact. Where appropriate, serve as role model/mentor/trainer for junior staff. Champion working environment that promotes collaboration, innovation, and creativity. Assist in process improvement initiatives and SOP development where applicable. Qualifications PhD, or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6+ years proven experience in pharmaceutical or related fields. Minimum Technical Knowledge and Skills: Advanced understanding of PK, PD, PKPD, and/or Translational Medicine. Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab). Proven understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.Proven ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan. Drug development experience in Immunology including understanding of disease, patient population, and treatment paradigm . Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid understanding of US, European, and Asian regulatory requirements and guidelines Excellent oral and written communication skills, including preparation of presentations are required. Has an established level of expertise or scientific reputation though publications and presentations at external meetings Other Requirements Estimated both domestic and international travel of about 5% of time. Primary Location Belgium-Antwerp-Beerse- Other Locations North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105970279W