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Principal Scientist II, Clinical Pharmacology and Pharmacometrics

3 months ago

Charleston, West Virginia, United States J&J Family of Companies Full time

Principal Scientist II, Clinical Pharmacology and Pharmacometrics W

Description

Johnson & Johnson Innovative Medicine is recruiting for a Principal Scientist II, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Raritan, NJ with possibility of remote work option (within the US).

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

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Therapeutic Area (TA) 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 or clinical pharmacology component of clinical studies, pharmacokinetics/pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) within a program, with guidance from senior CPP leaders. With oversight, the Principal Scientist CPP can function as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various partners within the team and within Quantitative Sciences (eg, Statistics, Pharmacometrics) and implement the day-to-day operations for the clinical pharmacology aspects of the assigned programs. Programs can be across all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support.

Key Responsibilities:

  • Contribute to overall compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (eg, metabolism, BCS classification, pharmacology, safety), PK, PD (eg, 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. Translate quantitative knowledge into strategic opportunities with to drive development along the model-informed drug development principles.
  • Plan and perform appropriate analysis (eg, non-compartmental, population and/or modeling 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.
  • Design and implement scientifically robust and efficient clinical pharmacology strategies for development candidates.
  • Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

Qualifications

Education:

  • PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 2 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 3 years of relevant experience.

Required:

  • Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.
  • Understanding of advanced analysis methods (eg, population analysis, PBPK, QSP) and modeling tools (eg, 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 US, European, and Asian (including BRIC countries) 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.
  • Has established a level of expertise and scientific reputation through publications and/or presentations.
  • Good written and oral communication skills (communication)

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range within the US for this position is to

The anticipated base pay range within the Bay Area for this position is to

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

  • Please use the following language:
  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k).
  • Employees are eligible for the following time off benefits:
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
  • Additional information can be found through the link below.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .

Primary Location NA-US-Pennsylvania-Spring House

Other Locations NA-United States, NA-US-New Jersey-Raritan

Organization Janssen Research & Development, LLC (6084)

Job Function Pharmacokinetics & Pharmacometrics

Req ID: W