Clinical Pharmacology (CP) Principal Scientist

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation – 120 hours/yr

Sick time – 40-56 hours/yr depending</

Paid holidays – 13 days/yr

Job summary

Johnson & Johnson Innovative Medicine is seeking a Clinical Pharmacology (CP) Principal Scientist to lead CP activities across CPP. You will design PK/PD analyses, contribute to model-informed drug development, and collaborate with cross-functional teams to support development programs.

The role involves writing CP sections for regulatory submissions, leading CP deliverables, and interfacing with regulatory bodies as needed. Travel 5–10% is expected.

Qualifications

• PhD or PharmD with 4+ years of relevant experience.
• Understanding of PK/PD and translational medicine.
• Experience with regulatory guidelines and model-informed drug development.

Responsibilities

• Contribute to compound development strategy using quantitative methods.
• Plan and conduct PK/PD analyses and translate to dose regimens.
• Author CP sections of regulatory documents and CSR.
• Lead CP deliverables in CPP studies within the CDT.

Skills

PK/PD understanding

MIDD knowledge

NONMEM

R

GastroPlus

Simcyp

Matlab

Education

PhD in Pharmaceutical Sciences or Clinical Pharmacology

PharmD or equivalent

Tools

NONMEM

R

GastroPlus

Simcyp

WinNonlin

Matlab

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com

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 https://www.jnj.com/innovative-medicine

We 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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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 :

$117,000.00 - $201,250.00

Additional Description For Pay Transparency

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

This position is eligible to participate in the Company’s long-term incentive program.

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: - https://www.careers.jnj.com/employee-benefits