The TA Scientist GCPâs role is to apply and promote Clinical Pharmacology (GCP) knowledge, including pharmacokinetics/pharmacodynamics analyses 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, QS-Project Matrix teams, GCP and PM Leaders. With oversight, the TA Scientist GCP can also execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs.
Accountabilities and responsibilities of the TA Scientist GCP 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. The TA Scientist GCP applies 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.
The TA Scientist GCP will assist GCP and PM leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
The TA Scientist GCP carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.Main Accountabilities:With assistance from senior members of the group
- 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. With assistance from senior members, the TA Scientist GCP will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Assist GCP and 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) studies and POC studies).
- Additional accountabilities
- Help design Phase I Clinical Pharmacology studies.
- Manage operational elements of CP studies with respective project GCP leaders
- Perform literature searches and summarize the findings.
- Help design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project.
- 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 GCP 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.
- Foster working environment that promotes collaboration, innovation, and creativity.
- Participate in user-group meetings and consortia where applicable.
- Assist in process improvement initiatives where applicable.
- Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity.
- 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 in one or multiple Therapeutic Areas and has the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
- Demonstrated understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development.
- Understanding of PK, PD, PK/PD, and Translational Medicine.
- Working knowledge of US, European, and Asian (including BRIC countries) regulatory requirements and guidelines.
- Ability to interpret PK and PKPD results and author report sections and prepare presentations to illustrate findings accurately
- Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).The TA Scientist GCPâs role is to apply and promote Clinical Pharmacology (GCP) knowledge, including pharmacokinetics/pharmacodynamics analyses 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, QS-Project Matrix teams, GCP and PM Leaders. With oversight, the TA Scientist GCP can also execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs.
Minimum Qualifications / Experience:
- PharmD, PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. Do you have a minimum 3 years of relevant experience (including postdoctoral studies);
United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=8590170822&lang=en
• Post ID: 158464942 newyork