[I050] - [Nn-528] | Distinguished Scientist, Clinical Pharmacology And Pharmacometrics

[I050] - [Nn-528] | Distinguished Scientist, Clinical Pharmacology And Pharmacometrics

Johnson & Johnson Innovative Medicine R&D; is recruiting for a Distinguished Scientist, Clinical Pharmacology and Pharmacometrics.
The preferred location for this position is Spring House, PA. Alternate locations are Titusville, NJ or Raritan, NJ.
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.




The Distinguished Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) will apply and promote clinical pharmacology expertise, including the design of clinical pharmacology components of 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 Distinguished Scientist CPP Leader will be responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including innovative approaches, and leading the regulatory strategy for clinical pharmacology.
As CPP Leader on the Compound Development Teams (CDT), the Distinguished Scientist will work in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics)



and provides recommendations that impact the drug development decisions for a program in addition to independently execute the day to day operations for the clinical pharmacology aspects of one or more programs within a disease area and provide management directly or indirectly to junior CPP leaders.
Principal Responsibilities: Planning and execution of the clinical pharmacology and model informed drug 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.




Translate quantitative knowledge into strategic opportunities with key stakeholders to drive development along the model-informed drug development principles.
Plan, perform, and/or provide oversight for appropriate analyses of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design and overall drug development strategy.
Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
Accountable for planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates and TA strategy.
Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies.
Manage directly or indirectly more junior CPP colleagues.




Carry out functional responsibilities in accordance with applicable Standard Operating Procedures (SOPs), regulatory requirements and Johnson & Johnson Credo principles.
Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches.
Manage and/or supervise operational elements of CPP studies.
Develop key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape.
Define regulatory strategy for CP and prepare CP contributions to regulatory documents including Investigator Brochures (IBs), Investigational New Drugs (INDs), briefing books, submission packages, responses to health authority questions, and other regulatory documents.




Influence external scientific and/or regulatory environment by establishing strong interactions with opinion leaders beyond Janssen R&D; and developing external collaborations with relevant professional organizations or consortium.
Develop expertise in relevant Therapeutic Area (TA), including understanding of pathophysiology, relevant pathway, patient population, competitive landscape, relevant endpoints.
Develop relationships and influence stakeholders (e.g., TA, regulatory, and other colleagues).
Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
Apply appropriate regulatory (e.g., FDA, EMA, ICH, etc.)
guidelines in the design of clinical development plans and studies.
Foster working environment that promotes collaboration, innovation, and creativity.
Qualifications: A minimum of a Ph.D. or equivalent degree in Pharmaceutical Sciences,



Clinical Pharmacology, Biomedical Engineering, or related Biological Sciences discipline is required.
A minimum of 10 years of experience in the Pharmaceutical or related industries is required.
Expert knowledge and understanding of PK, PD, PK-PD, and/or Translational Medicine and their applications in model informed drug development (MIDD) is required.
Understanding of advanced analysis methods (e.g., population analysis, physiologically based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is required.
Demonstrated experience and capability in development of and aiding decisions with model-based approaches is required.
Understanding of overall process of drug development including model informed drug development (MIDD)



and the overall pharmaceutical R&D; process is required.
Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology and drug development strategy is required.
Extensive drug development experience in one or multiple therapeutic areas, including understanding of disease, patient population, and treatment paradigms is required.
Understanding of U.S., European, and Asian regulatory requirements and guidelines is required.
Established level of expertise and scientific reputation through publications and/or presentations is preferred.
Must have excellent communication skills.
Must be a self-motivated team player who excels in a collaborative, multi-disciplinary team environment.
Must have strong leadership skills and the ability to mentor junior colleagues, inspire others,



and set a positive example by providing assistance, recognition and encouragement.
The ability to interact with team members, stakeholders and regulatory authorities, and collaborate effectively in a matrix environment is required.
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.
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