Associate Scientific Director, Immunology

    • Spring House, PA

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Scientific Director, Immunology Therapeutic Area (TA) located in 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 Associate Scientific Director, Immunology 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 Associate 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 Associate 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.

Main responsibilities:

  • 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 Associate 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.
  • Design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project.
  • Design Phase I Clinical Pharmacology studies.
  • 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.
  • 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.


Qualifications

Required qualifications:

  • PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with 5+ years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 7+ 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 Immunology (preferred) and/or other Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously preferred.
  • 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).
  • Estimated both domestic and international travel up to 10% of time.


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.

Primary Location
United States-Pennsylvania-Spring House-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
8082200207


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