Clinical Pharmacology (CP) Principal Scientist

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

6d•$117,000 - $201,250•Hybrid

About The Position

The 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 and/or clinical pharmacology component of clinical studies, pharmacokinetics/pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) to specific studies within a program, with guidance from senior CPP leaders. With oversight, the Senior Scientist can function as CP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within CPP (e.g., Pharmacometrics) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned studies and/or programs. Programs can be across all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through post-marketing support.

Requirements

PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Biomedical Engineering, or relevant Biological Sciences, with 4+ years of relevant experience or PharmD degree or equivalent, with 4+ years of relevant experience.
Understanding of PK, PD, PK/PD, and/or Translational Medicine.
Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., 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 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.
Able to travel 5-10%.

Nice To Haves

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

Responsibilities

Contribute to the overall compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., 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.
Plan and perform appropriate analysis (e.g., non-compartmental, population and/or modelling 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.
Contribute to the design and execution of scientifically robust and efficient clinical studies and pharmacology strategies for development candidates.
Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Plan and conduct PK and PK/PD analyses, provide independent QC, and report results in appropriate format (e.g., team presentations, memo, CSR).
Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies, consistent with regulatory guidelines.
Manage operational elements of CPP studies.
Author CP sections of IB, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
May represent CPP at regulatory interactions.
Contribute to the knowledge of clinical pharmacology, 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 (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.).
Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 the birth/adoption/foster care of a child
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