Principal Scientist, Clinical Pharmacology & Pharmacometrics

Johnson & Johnson Co.; Raritan (NJ); Hybrid; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Scientist in Clinical Pharmacology & Pharmacometrics to lead CP strategy across programs, interact with regulatory agencies, and guide PK/PD analyses from discovery through development.

You will design Phase I studies, oversee PK/PD modeling, and contribute to regulatory submissions while mentoring teams in a matrix environment.

Qualifications

• PhD or equivalent degree with 5+ years in pharma or related fields.
• Understanding PK, PD, PK/PD, and translational medicine required.
• Experience with advanced analysis methods and modeling tools.
• Knowledge of MIDD and regulatory guidelines is essential.
• Strong communication skills for presenting to leadership and regulators.
• Willingness for domestic and international travel (~5%).
• Regulatory experience and cross-functional collaboration skills.

Responsibilities

• Devising CP and MIDD strategy to influence dose and development plans.
• Plan and oversee PK/PD analyses and dose/exposure relationships.
• Interpret PK/PD results for development programs and use in regulatory filings.
• Deliver robust CP strategies for development candidates.
• Lead CP activities with SOPs and regulatory requirements.
• Define regulatory strategy and contribute to regulatory documents.
• Collaborate with cross-functional teams and external scientific community.

Skills

Clinical pharmacology

PK/PD understanding

Modeling & simulation

Regulatory interactions

Education

PhD in Pharmaceutical Sciences/Clinical Pharmacology/Biomedical Engineering

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 a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for our Principal Scientist Clinical Pharmacology & Pharmacometrics position, to be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.

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

Purpose:

The Clinical Pharmacology (CP) Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology studies and/or clinical pharmacology components of clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of model-informed drug development (MIDD) principles across all stages of drug development. The Principal Scientist CP Leader develops compound-specific Clinical Pharmacology strategies for supported programs, including interactions with regulatory agencies, and serves as the CP Leader on cross-functional compound teams and within CPP (e.g., Pharmacometrics). The Principal Scientist independently leads the day-to-day clinical pharmacology activities for programs within the Portfolio and Lifecycle Management (PALM) organization, focused on established brands and post-approval development opportunities.

You will be responsible for:

• Devising the clinical pharmacology and model informed drug 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 sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development. Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD analyses and reporting.
• Devising clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines.
• Managing and/or supervising elements of CPP studies.
• Developing key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape.
• Defining regulatory strategy for CPP and prepare CP contributions to regulatory documents including IBs, IND's, briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participating in the evaluation of potential business development opportunities.
• Contributing 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.) and identify new opportunities for applied scientific and technical advancement within the department.
• Working effectively in team environments, managing CP deliverables in accordance with timelines and overall project goals.

Qualifications / Requirements:

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

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check

#LI-Hybrid

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)).

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