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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
 

Learn more at https://www.jnj.com/innovative-medicine   
             

We are searching for the best talent for a Principal Scientist, Clinical Pharmacology to be located in Spring House, PA.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
 

Purpose: The Therapeutic Area (TA) Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply clinical pharmacology knowledge, including design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/ pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) to specific studies within a program, with guidance from senior CPP leaders.

With oversight, the Principal Scientist may also function as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various collaborators within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics) and complete the day-to-day operations pertaining to all aspects of clinical pharmacology for the programs they are assigned to. Programs can be across all stages of drug development ranging from New Molecular Entity (NME) declaration through Post-Marketing support.
 

You will be responsible for:

• Contributing to overall compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support dose and dosage regimen selection, and optimize study designs throughout drug development.
   
• Performing non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data including preclinical-clinical translation, dose/exposure-response relationships to guide dose regimen and optimize study design.
   
• Summarizing and providing interpretation of results of PK and PK/PD analyses.
   
• Contributing to the design and execution of scientifically robust and efficient clinical pharmacology strategies for development candidates.
   
• Carrying out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
   
• Conducting PK and PK/PD analyses, providing independent QC, and reporting results in appropriate format (e.g., team presentations, memo, CSR).
   
• Providing protocol elements contributing to the design of Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
   
• Managing operational elements of CPP studies with oversight from project CPP Leader.
   
• Performing literature searches and summarizing the findings.
   
• With oversight, contributing to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
   
• Accumulating knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by taking in-house training and/or engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.).
   
• Working effectively in a matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
   
• Becoming familiar with and applying appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the development of clinical development plans and studies.
   
• Applying relevant technical trainings/findings to daily responsibilities, with focus on opportunistic delivery of value/impact.
   

Qualifications/Requirements

Education:

• PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 4+ years of relevant experience or a Master's or PharmD degree with 6+ years of relevant experience is required.
   

Experience and Skills:

• Understanding of PK, PD, PK/PD, and/or Translational Medicine is required.
   
• Experience with advanced analysis methods (e.g., population analysis, PBPK, QSP) is required.
   
• Experience with modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is a plus.
   
• Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively is required.
   
• General understanding of the overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process is required.
   

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research