Principal Scientist Pmetrics

Johnson & Johnson Innovative Medicine; Beerse; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist Pharmacometrics to co-develop and execute PK/PD modeling for compounds in development. You will author pharmacometrics documents for regulatory submissions and contribute to Agency interactions.

The role involves developing Model Informed Drug Development plans, performing day-to-day pharmacometric analyses, and coordinating with clinical pharmacology leaders and other stakeholders. Travel ~5% is anticipated.

Qualifications

• Ph.D. degree or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio-Engineering or Biological Sciences, with 2+ years post-doctoral experience or MS with 4+ years of relevant experience.
• Strong knowledge of PK/PD modeling and simulation concepts and methods.
• Hands-on experience with pharmacometrics software (NONMEM, Monolix, R).
• Familiarity with regulatory submissions and MIDD concepts is important.

Responsibilities

• Conduct population PK, PD, ER analyses to inform dose regimen and development decisions.
• Write analysis plans and reports, define data requirements, perform QC checks, interpret PK/PD results.
• Work in a matrix environment to manage pharmacometrics deliverables to timelines.
• Contribute to development of new methods and applications in pharmacometrics.

Skills

Pharmacometrics

Pharmacokinetics

Pharmacology

Program Management

Research Proposals

Report Writing

Education

Ph.D. in Pharmaceutical Sciences

Tools

NONMEM

Monolix

R

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:

Beerse, Antwerp, Belgium

Job Description

The Principal Scientist Pharmacometrics position is responsible for the co-development and execution of population pharmacokinetic [PK], pharmacodynamic [PD], and exposure-response(ER) modeling and simulation activities related to the planning, implementation, analysis, interpretation, and reporting for compounds in development. Additional responsibilities include the authoring of pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and contributing to meetings with Regulatory Agencies and Advisory Committee Meetings.

The position is responsible for contributing to the development of Model Informed Drug Development(MIDD)planswith guidance fromsenior members of the group, clinical pharmacology leadersand other stakeholders. With guidance, thePrincipal Scientistcan execute the day-to-day operations for thepharmacometricanalysesof the assigned programs.

You Will Be Responsible For

• Conduct population PK, PD, ER analyses to informdose regimen selectionand otherkeydrug development decisions,support the designof clinicalstudies and model-informed drug development plans,andto support regulatory submissions.
• Writeanalysis plans & reports,define datarequirements,conductanalyses, perform quality control (QC) checks,and interpret PK/PD data and results.
• Workeffectively in a matrix environment, managing pharmacometricsdeliverablesin accordance withtimelines and overall project goals.
• Contribute to the development of new methodology and/or applications of pharmacometrics.

Other Accountabilities & Tasks

• Presentinternally and atexternalscientificmeetings; prepare and publish manuscripts in peer reviewed scientific journals; mayparticipateinspecial interest groups within professional societies.
• Assist in process improvement initiatives, software validationandother technology improvements.
• Carryout functional responsibilitiesin accordance withapplicable SOPs, departmental processes and Regulatoryrequirements,and Johnson & Johnson Credo principles.

Education And Experience Requirements

• Ph.D. degree or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio- Engineering or Biological Sciences, with2+years of post-doctoral experience or M.S. degree with 4+ years of relevant experience.

Minimum Technical Knowledge And Skills

• Working knowledge of PK & PK/PD modeling and simulation (pharmacometrics) concepts and methods.
• Hands-on knowledge of pharmacometrics modeling software (NONMEM and/or Monolix, R).
• Understanding of the overall drug development process including MIDD and the Pharmaceutical R&D process.
• Working knowledge ofregulatory requirements and guidelines.
• Good oral and written communication skills.

Estimated both domestic and international travel of about 5% of time.

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

€79 800,00 - €137 770,00

Benefits

• In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional Information

79 800,00 - 159 600,00 EUR Annual