Principal Scientist, Clinical Pharmacology & Pharmacometrics

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 innovate across the full spectrum of healthcare solutions to deliver breakthroughs for tomorrow.

About the role

We are searching for a Principal Scientist in Clinical Pharmacology & Pharmacometrics to be located in Raritan, NJ; Titusville, NJ; or Spring House, PA. This role applies and promotes clinical pharmacology expertise, including the design of clinical pharmacology studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis, and model-informed drug development (MIDD) principles across all stages of drug development.

The Principal Scientist CP Leader develops compound-specific Clinical Pharmacology strategies, serves as the CP Leader on cross-functional teams, and independently leads day-to-day clinical pharmacology activities for programs within the Portfolio and Lifecycle Management (PALM) organization, focusing on established brands and post-approval development opportunities.

Responsibilities

• Devise clinical pharmacology and model-informed drug development strategies using quantitative methods to integrate nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD, patient characteristics, disease states, and drug interactions to influence go/no-go decisions, dose selection, and study design optimization.
• Translate quantitative knowledge into strategic opportunities to guide development using model-informed drug development principles.
• Plan, perform, or oversee analyses (e.g., non-compartmental, population, and modeling/simulation of PK/PD data) to guide dose regimen and study design.
• Summarize and interpret PK and PK/PD results to assess their impact on development programs and clinical use.
• Deliver scientifically robust clinical pharmacology strategies for development candidates.
• Carry out functional responsibilities in accordance with SOPs, regulatory requirements, and Johnson & Johnson Credo principles.
• Plan, conduct, or oversee PK and PK/PD analyses and reporting.
• Develop clinical pharmacology strategies, including Phase I study designs or alternative modeling approaches, consistent with regulatory guidelines.
• Manage or supervise elements of CPP studies.
• Develop key product differentiation strategies based on a compound’s attributes and therapeutic landscape.
• Define regulatory strategy for CPP and prepare contributions to regulatory documents (e.g., IBs, INDs, briefing books, submission packages, responses to health authority questions). Represent CP in external regulatory meetings (e.g., End of Phase 2, pre-NDA/MAA, Advisory Committee meetings).
• Participate in evaluating potential business development opportunities.
• Contribute to the advancement of clinical pharmacology, MIDD, and drug development processes by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in professional societies).
• Work effectively in team environments, managing CP deliverables in accordance with timelines and project goals.

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 Translational Medicine.
• Proficiency in advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).
• Understanding of the drug development process, including MIDD and pharmaceutical R&D.
• Working knowledge of regulatory requirements and guidelines.
• Strong oral and written communication skills, including the ability to interpret PK/PKPD results and prepare effective presentations.
• Approximately 5% domestic and international travel required.

Pay

The anticipated base pay range for this position is $117,000.00 - $201,250.00.

Benefits

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)).

• Time Off Benefits:
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
  • 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 birth/adoption/foster care
  • 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 period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year