The Therapeutic Area (TA) Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply and promote Clinical Pharmacology knowledge, including pharmacokinetics/ pharmacodynamics analyses and principles of model-based drug development in the programs across all stages of drug development ranging from New Molecular Entity (NME) declaration through Post-Marketing support, in collaboration with various stakeholders, QS-Project Matrix teams, CPP Leaders, and Pharmacometrics Leaders. With oversight, the Scientist may also function as CPP Leader on the Compound Development Teams (CDT) and execute the day-to-day operations pertaining to all aspects of clinical pharmacology for the programs they are assigned to.
The TA Scientist acting as CPP Leader can directly impact the operational results, as they are focused on investigation and characterization of how drugs interact with biological systems or diseases so they can be used safely and effectively, and with the appropriate pharmaceutical formulation.
- Contribute to 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 stake holders 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 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).
- Assist CPP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
- Applies the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes.
- Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Other Accountabilities & Tasks
- Help design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project.
- Help design Phase I Clinical Pharmacology studies.
- Manage operational elements of CPP studies with respective project CPP Leaders.
- Perform literature searches and summarize the findings.
- Contribute to preparation of monographs, INDs and other documents as applicable to support clinical studies.
- 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 CPP 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 on opportunistic delivery of value/impact.
Minimum Qualifications / Experience
- PharmD, PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. Ph.D. degree or equivalent, with 0-2 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 1-3 years of relevant experience.
Minimum Technical Knowledge and Skills
- Understanding of PK, PD, PK/PD, and Translational Medicine.
- Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately.
- General understanding of overall process of drug development and the overall pharmaceutical R&D process.
- Has established a level of expertise and scientific reputation through publications and/or presentations.
- Drug development experience (preferred) .
- Demonstrated understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and/or biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development.
- General knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).
Estimated both domestic and international travel of about 5% of time.
Janssen Pharmaceutica N.V. (7555)