Scientific Director, Clinical Pharmacology Immunology Therapeutic Area (TA)

Job Description Janssen R&D is recruiting for a Scientific Director, Clinical Pharmacology Immunology TA, located in Springhouse, PA.

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The 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 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 Key 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 Scientific Director will translate quantitative knowledge into strategic opportunities with key stakeholders to drive development along the model-based drug development principles.

Collaborate with Pharmacometrics (PM) Leaders on modeling and simulation activities in drug development programs.

Perform and/or liaise for modeling and simulation analysis of clinical data, translational PK/PD data, dose/exposure-response analyses to guide dose regimen from first-in-human to registrational studies.

Collaborate with PM Leaders on the execution of scientifically robust and efficient clinical pharmacology strategies for development candidates.

Prepare clinical pharmacology regulatory submission packages for INDs, NDAs and BLAs as well as other regulatory documents.

Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Qualifications Qualifications Education: PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Clinical Medicine, Biomedical Engineering, or relevant Biological Sciences is required A minimum of 8 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 10 years of relevant experience is required.

Experience and Skills: Required: 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.

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 pathophysiology and mechanisms of drug action, available treatment paradigms, and patient populations for assigned disease area(s).

This role is located in Spring House, PA and may require up to 10% travel.

Preferred: 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.