This individual is to apply and promote CPP knowledge, including pharmacokinetics (PK)/ pharmacodynamics (PD) analyses, translational modelling and principles of model-based drug development in the programs for all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support, in collaboration with various stakeholders, Quantitative Sciences (QS)-Project Matrix teams and Pharmacometrics (PM) Leader.
Depending on the experience, this individual may function as a CP Leader on the Compound Development Team (CDT) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs.
- Contribute to overall compound development 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. Working closely with the senior members, translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Perform modeling and simulation activities in drug development programs, in collaboration with senior members and Pharmacometric (PM) Leaders. Perform and/or liaise 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). Help provide PKPD guidance to Phase 2-3 studies.
- Execute scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates, working together with senior members.
- Apply the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on PK and PK/PD, and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes.
- Carry out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
- Help design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project.
- Manage operational elements of Clinical Pharmacology studies.
- Perform literature searches and summarize the findings.
- Contribute in monographs, INDs and other documents as applicable to support clinical studies and regulatory filings (e.g. NDA/BLA).
- Represent Clinical Pharmacology Function in the regulatory meetings (e.g. pre-IND, EoP1, EoP2, NDA/BLA filing etc.) with the assistance of the senior member as appropriate.
- Remain current with clinical and drug development information and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and internalize key learnings back to Janssen.
- Support CP and PM Leaders with ad hoc analyses, not limited to non-compartmental analyses in support of Phase I studies
- Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
- Apply relevant technical trainings/learnings to daily responsibilities, with focus of opportunistic deliver of value/impact.
- PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. OR Have a PharmD degree or equivalent with a minimum of 1 year of relevant experience.
- Understanding of PK, PD, PK/PD, and Translational Medicine is required.
- Have experience analyzing data describing biological or PK/PD systems, preferably using a non-linear mixed effects modeling approach.
- Ability to interpret PK and PK/PD results and prepare presentations to illustrate findings accurately is required.
- Understanding of overall process of drug development and the overall pharmaceutical R&D process is required.
- Established a level of expertise and scientific reputation through publications and/or presentations.
- Drug development experience in Immunology (preferred) and/or other Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
- Demonstrated understanding of model-based drug development, biostatistics principles and modelling tools (e.g., NONMEM, R, Phoenix NLME, R, SimCYP, Gastro-Plus, MATLAB, SAS, or similar software) and demonstrated ability to apply these tools to enable rational and efficient drug development.
- Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).