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Senior Principal Scientist, Pharmacometrics Leader

2 months ago

Columbus, Ohio, United States J&J Family of Companies Full time

Senior Principal Scientist, Pharmacometrics Leader W

Description

Johnson and Johnson is currently seeking a Senior Principal Scientist, Pharmacometrics Leader located in Raritan, NJ or Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the company.

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 Senior Principal Scientist, Pharmacometrics role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (eg, Statistics, Pharmacometrics). The Senior Principal Scientist CPP Leader can independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.

Primary responsibilities:

  • Devise model informed drug development strategy via application of quantitative methods to integrate knowledge of PK, PD (eg, biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive and landscape 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 key stake holders to drive development along the model-informed drug development principles.
  • Plan, perform, and/or provide oversight for appropriate analyses (eg population and/or modeling and simulation analysis of PK and/or PD data) of clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.
  • Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use
  • Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
  • Plan, conduct PK and PK/PD analyses and reporting
  • Prepare CP contributions to regulatory documents including briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CPP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA/MAA, Advisory Committee meetings).
  • Participate in the evaluation of potential business development opportunities.
  • Stay abreast of 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 (eg, 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.
  • Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact. Where appropriate, serve as mentor/trainer for junior staff.
  • Foster working environment that promotes collaboration, innovation, and creativity
  • Assist in process improvement initiatives and SOP development where applicable.

Qualifications

Education:

  • Master's Degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 9 years of experience in pharmaceutical, biomedical, or related field required
  • PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical, biomedical, or related field preferred

Required:

  • Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine
  • Experience with modeling tools (eg, NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab)
  • Understanding of advanced analysis methods (eg, population analysis, PBPK, QSP)
  • Demonstrated 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 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 and influence stakeholders
  • Has established a strong level of expertise and scientific reputation through multiple publications and presentations.
  • Up to 10% travel - Domestic & International

Preferred:

  • Drug development experience including understanding of disease, patient population, and treatment paradigm.
  • Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan

The anticipated base pay range for this position in the US is $135,000 to $232,300.

The anticipated base pay range for this position in San Francisco Bay Area is $166,000 to $267,145.

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.

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
  • Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to:

This job posting is anticipated to close on July 17, 2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

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.

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-United States, NA-US-Pennsylvania-Spring House

Organization Janssen Research & Development, LLC (6084)

Relocation Eligible: No

Job Function Pharmacokinetics & Pharmacometrics

Req ID: W