Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Associate Scientific Director, Clinical Pharmacology to be located in Raritan, NJ with consideration given to Titusville, NJ and Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies.
The Clinical Pharmacologist role is responsible for providing 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. Clinical Pharmacologists will be responsible and accountable for developing compound specific Clinical Pharmacology Development Plan (CPDP). Collaborating with diverse stakeholders, QS-project matrix teams and QS-TALs, the Clinical pharmacologists will apply and promote Clinical Pharmacology knowledge, including that of model-based drug development, in the programs they support for all stages of drug development. Independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs by managing directly or indirectly teams of employees of different levels.
• 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. Responsible for appropriate summarization and interpretation of results of PK/PD analyses with respect to their impact on development and clinical use of drugs. Independently or with assistance from senior members of the group whenever necessary, clinical pharmacologists will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
• Accountable for all modeling and simulation activities in the program. 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); Whenever appropriate perform and/or provide input and guidance to the prediction of clinical response and study outcomes of Phase 2b, and Phase 3 trials and to optimize trial designs. Consider alternate and appropriate dosing recommendations for special situations (e.g., drug interaction, food effect, pharmacogenomics effect, pediatric, elderly, renal impairment, hepatic impairment).
• Partner with functional representatives in biology, chemistry, biomarker, translational medicine, CDTLs and clinicians to develop CPDP and design suitable early PKPD plans on projects
• Engage discovery project teams early to aid in PKPD, biomarker, and efficacious dose prediction strategies
• Design and execute PKPD 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
• Seamlessly transfer project knowledge/assets to the relevant team upon FIH (or an alternative mutually agreed upon point)
• Where applicable, find common areas of need across projects (and possibly across TAs) that could benefit from a common modeling approach/platform
• Mentor other CP colleagues in the science of preclinical PKPD modeling, simulation and efficacious dose prediction
• 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
• Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape in CPDP; subsequently continue to liaise 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.
• Present and/or publish scientific data at conferences and in peer-reviewed journals, stay abreast of new emerging technologies in relevant scientific fields; identify new opportunities for applied scientific and technical advancement within the division.
• Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
• Apply appropriate regulatory (eg: 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. Where appropriate, serve as role model/mentor for junior staff
• An M.S. Degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences or PharmD with a minimum of five (5) years of pharmaceutical development experience with at least three (3) years of relevant experience performing progressively advanced duties at the Senior Scientist level OR a PhD, MD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with a minimum of four (4) years of pharmaceutical development experience with at least 3 years of relevant experience performing progressively advanced duties at the Senior Scientist level.
• Demonstrated understanding of overall process of drug development and the overall pharmaceutical R&D process is required.
• Has established a strong level of expertise and scientific reputation through multiple publications and presentations, preferred.
• Broad drug development experience in one or multiple Therapeutic Areas and has the ability to lead and / or oversee multiple smaller clinical pharmacology programs, required.
• Demonstrated understanding of model-based drug development, biopharmaceutics classification system (BCS), and biostatistics principles and tools (eg. gastroplus, simcyp, Winnonlin, NONMEM etc.) and demonstrated ability to apply these tools to enable rational and efficient drug development is required.
• Demonstrated understanding of PK, PD, PK/PD, and Translational Medicine is required.
• Good understanding of clinical drug development and the overall pharmaceutical R&D process is required.
• Working knowledge of US, European, and Asian regulatory requirements and guidelines is required.
• Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s) is required.
This position is located in Raritan, NJ with consideration given to Titusville, NJ and Spring House, PA and may require up to 10% domestic and international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)