Director, Clinical Pharmacology and Pharmacometrics

Janssen Research & Development, LLC, a member of the J&J family of companies is recruiting for a Director, Clinical Pharmacology & Pharmacometrics to be located in Raritan, NJ or Spring House, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. The 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. The Director CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound including innovative approaches and leads the regulatory strategy for clinical pharmacology. As CPP Leader on the Compound Development Teams (CDT), the Director works 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. The Director CPP leader contributes to the strategic direction of CPP department and/or TA. Key Responsibilities: 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 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. 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. Other Accountabilities & Tasks: 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 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 (eg: 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 QS. Qualifications PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences is required. 10-12+ years of experience in pharmaceutical or related fields required. Expert knowledge and understanding of PK, PD, PK-PD, and/or Translational Medicine and their applications in model informed drug development (MIDD) required. Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) preferred. Demonstrated experience and capability in development of and aiding decisions with model-based approaches required. Thorough understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process required. Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology and drug development strategy required. Extensive drug development experience in one or multiple therapeutic areas including understanding of disease, patient population, and treatment paradigms required. Thorough understanding of US, European, and Asian regulatory requirements and guidelines preferred. Excellent communication skills, leading meetings and interacting with team members, stakeholders, and regulatory authorities required. Has established a strong level of expertise and scientific reputation through multiple publications and presentations preferred . Outstanding leadership and ability to mentor junior colleagues, exemplified through the ability to inspire others, to set a positive example by providing assistance, recognition and encouragement required. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-New Jersey-Raritan-920 US Highway 202 Other Locations North America-United States-Pennsylvania-Spring House Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206025006W