Clinical Pharmacology (CP) Principal Scientist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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 Titusville New Jersey 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 are searching for the best talent for a Clinical Pharmacology (CP) Principal Scientist .

Purpose: The Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology knowledge including the design of clinical pharmacology studies and/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 Senior Scientist can function as CP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within CPP (e.g. Pharmacometrics) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned studies and/or programs. Programs can be across all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through post-marketing support.

You will be responsible for:

• Contribute to the 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 patient sub-population dose and dosage regimen selection and optimize study designs throughout drug development.
• Plan and perform appropriate analysis (e.g. non-compartmental population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation dose/exposure-response relationships to guide dose regimen and optimize study design.
• Summarize and provide interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Contribute to the design and execution of scientifically robust and efficient clinical studies and pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs regulatory requirements and Johnson & Johnson Credo principles.
• Plan and conduct PK and PK/PD analyses provide independent QC and report results in appropriate format (e.g. team presentations memo CSR).
• Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies consistent with regulatory guidelines.
• Manage operational elements of CPP studies.
• Author CP sections of IB briefing books submission package and other regulatory documents as applicable to support clinical studies and/or programs.
• May represent CPP at regulatory interactions.
• Contribute to the knowledge of clinical pharmacology model informed drug development analysis methodology and overall drug development process including regulatory guidance and methods in modelling and simulation by engaging with the scientific community (e.g. publishing presenting at meetings participating in special interest groups within professional societies etc.).
• 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.

Qualifications / Requirements:

• PhD or equivalent degree in Pharmaceutical Sciences Clinical Pharmacology Pharmacometrics Biomedical Engineering or relevant Biological Sciences with 4 years of relevant experience or PharmD degree or equivalent with 4 years of relevant experience.
• Understanding of PK PD PK/PD and/or Translational Medicine.
• Understanding of advanced analysis methods (e.g. population analysis PBPK QSP) and modeling tools (e.g. NONMEM R Gastroplus Simcyp Winnonlin Matlab).
• Understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.
• Working knowledge of regulatory requirements and guidelines.
• Good oral and written communication skills including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.
• Able to travel 5-10%.

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 internal employees contact AskGS to be directed to your accommodation resource.
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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

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay including Floating Holidays 13 days per calendar year
Work Personal and Family Time - up to 40 hours per calendar year
Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Staff IC