Director, Clinical Pharmacology & Pharmacometrics (CPP)

Company: Disability Solutions
Location: Raritan
Posted on: October 11, 2024

Job Description:

Johnson & Johnson is recruiting for a Director, Clinical Pharmacology & Pharmacometrics (CPP) located in Raritan, NJ; Spring House, PA or La Jolla, CA.\rAt 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/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rThe Therapeutic Area (TA) Clinical Pharmacology Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to 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.\rThe Director, CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound including innovative ways and leads the regulatory strategy for clinical pharmacology. As CPP Leader on the Compound Development Teams (CDT), the Director works in collaboration with various partners 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 complete 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. The Director CPP leader contributes to the strategic direction of CPP department and/or TA.\rKey Responsibilities:

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• Responsible for the 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 partners 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.
• Responsible for 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.
• Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Plan, conduct, and/or provide oversight of PK and PK/PD analyses and reporting
• 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 IBs, IND's, 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 / 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 TA including understand of pathophysiology including relevant pathway, patient population, competitive landscape, relevant endpoints.
• Develop relationships and influence partners (e.g., TA, regulatory, and other colleagues).
• Work effectively in a 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 implemented, 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 QS.
• Participating in program committees, coordinating sessions, presenting at scientific meetings, and publishing in peer reviewed journals.\r\r

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