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. Learn more at https://www.jnj.com/

• 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 stake holders 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. Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA/Marketing Authorization Application (MAA), Advisory Committee meetings).
• Participate in the evaluation of potential business development opportunities.
• Stay abreast of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• 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 understand 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.
• Assist in process improvement initiatives and SOP development where applicable.
• Attend governance and advisory meetings representing CP function, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.
• Provide and arrange training and presentations on innovative CP approaches across the R&D organization, ensuring awareness and adequate knowledge about CPP capabilities and expertise within the TA and Quantitative Sciences (QS).
• Participating in program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals.

• 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.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year