Principal Scientist, Pharmacometrics

Job title:

Principal Scientist, Pharmacometrics

Company

Johnson & Johnson

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 https://www.jnj.comJob Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Pharmacokinetics & PharmacometricsJob Category: Scientific/TechnologyAll Job Posting Locations: Beerse, Antwerp, BelgiumJob Description:Principal Scientist – Clinical Pharmacology & PharmacometricsAbout Innovative MedicineOur 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 atWe are searching for the best talent for Principal Pharmacometrics (PM) Scientist to join our Clinical Pharmacology & Pharmacometrics (CPP) team in Beerse, Belgium.Purpose
In this role, you will leverage your expertise in pharmacokinetics/pharmacodynamics (PK/PD) and model-based drug development principles to advance our drug development programs, spanning from pre-New Molecular Entity (NME) declaration through post-marketing support. You will collaborate with a range of stakeholders, including Project Matrix teams, Clinical Pharmacology and Pharmacometrics (CPP and PM) Leaders. As a Principal PM Scientist, your contributions will have a direct impact on operational outcomes, focusing on the investigation and characterization of how drugs interact with biological systems and diseases to ensure their safe and effective use with the appropriate pharmaceutical formulations.Responsibilities

• Pharmacometric Application: Utilize your understanding of (1) the effects of intra- and inter-subject variability in physiology and pathology, concomitant medication use, and biopharmaceutics on pharmacokinetics (PK) and pharmacodynamics (PD), and (2) the requirements for clinical pharmacology regulatory submission packages and processes.
• Strategic Leadership: Act as a PM leader or support CPP and PM Leaders in the execution of scientifically sound and efficient clinical pharmacology strategies for NMEs and development candidates.
• Compliance and Standards: Maintain functional responsibilities in alignment with applicable Standard Operating Procedures (SOPs), regulatory requirements, and the Johnson & Johnson Credo principles.

Accountabilities (with support from senior team members):

• Compound Development Contribution: Utilise quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions. This work will help optimize dose selection, dosage regimens, and study designs throughout the drug development process. With guidance from senior members, you will translate quantitative insights into strategic opportunities that engage key stakeholders and facilitate development consistent with model-based drug development principles.
• Modelling and Simulation Leadership: Fulfil a leadership role in modelling and simulation activities within drug development programs. Conduct analyses of preclinical and clinical data, and translational PK/PD data, supporting dose/exposure-response assessments to guide dose regimens from pre-proof of concept (POC) through to Phase 3 studies, in addition to supporting regulatory submissions.

Additional Responsibilities:

• Conduct comprehensive literature searches and synthesize PK/PD findings.
• Design and implement PK, PK/PD modelling efforts to tackle project-specific challenges, or collaborate with PM leaders in these tasks.
• Assist in the preparation of monographs, Investigational New Drug applications (INDs), and other documentation to support pharmacometric analyses.
• Stay updated on clinical and drug development advancements by engaging with the scientific community through publishing, presenting at conferences, and participating in professional societies, integrating key insights into our practice at Janssen.
• Provide support to CPP and PM Leaders with ad-hoc pharmacometric analyses as required.
• Effectively operate within a matrix environment, managing PM deliverables to align with timelines and project objectives.
• Apply relevant regulatory guidelines (e.g., FDA, EMEA, ICH) while designing clinical development plans and studies.
• Integrate relevant technical training and insights into daily responsibilities, aiming to deliver impactful results.

Qualifications/Requirements:

• PhD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 0-3 years of relevant experience (including postdoctoral studies) or, an MS or PharmD degree or equivalent, with 1-2 years of relevant experience.
• Understanding of overall process of drug development and the overall pharmaceutical R&D process.
• Has established a level of expertise and scientific reputation through publications and/or presentations.
• Drug development experience in one or multiple Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
• Demonstrated understanding of model- based drug development (MBDD), physiologically based pharmacokinetics/pharmacodynamics (PBPKPD), and biostatistics principles and tools (e.g., Simcyp, NONMEM, or Winnonlin) and demonstrated ability to apply these tools to enable rational and efficient drug development.
• Understanding of PK, PD, PK/PD, and Translational Medicine.
• Knowledge on biologics PK/PD modeling would be great plus.
• Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately.
• Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).

Up to 10% travel will be required both domestic and international.BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Expected salary

Location

Beerse, Antwerpen

Job date

Thu, 20 Mar 2025 01:35:31 GMT

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