- Entry level
- No Education
- Salary to negotiate
- Spring House
The Scientific Director, Oncology Therapeutic Area (TA) Clinical Pharmacology (CP) Leader role is to apply and promote Clinical Pharmacology 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, Quantitative Sciences (QS)-Project Matrix teams and Pharmacometrics (PM) Leader. The Scientific Director will function as a CP Leader on the Compound Development Team (CDT) independently and execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs and mentor junior members within the Clinical Pharmacology and Pharmacometrics Department.
The Scientific Director can directly impact the operational results, as they are focused on investigation and characterization of how drugs interact with biological systems or diseases so that they can be used safely and effectively, and with the appropriate pharmaceutical formulation.
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. The Scientific Director will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
Collaborate with PM Leaders on 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).
Collaborate with PM Leaders on 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.
PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with 8+ years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 10+ years of relevant experience.
Understanding of PK, PD, PK/PD, and Translational Medicine.
Ability to interpret PK and PK/PD results and prepare presentations to illustrate findings accurately.
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 Oncology (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 (MBDD), biostatistics principles and modelling tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) 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).
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC. (6084)
About the company
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