Associate Director, Clinical Pharmacology and Pharmacometrics (1 of 2)

Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ.

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. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:

• Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.
• Accountable for all CP trial design, analysis of data, reporting and interpretation of results.
• Design and execution of appropriate modeling plans along with the Pharmacometric scientist assigned to the project.
• Entertain strong interactions with opinion leaders beyond Janssen R&D, with a goal to represent CPP and influence the scientific and regulatory environment.
• Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacodynamic analysis for drug development projects.
• Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.
• Will drive early alignment on key development questions where CP principles could be applied.
• Conduct methodological research and effectively apply state-of-the-art scientific/technical knowledge to projects.
• Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies.
• Keep up-to-date knowledge of model-based drug development with a focus on Clinical pharmacology, biopharmaceutics, PKPD & other related analytical sciences including implementation of innovative methods to preclinical research, translational sciences and clinical development.
• Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, and 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.
• 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 alternative 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
• Apply appropriate regulatory (eg: FDA, EMA, PMDA, ICH etc) guidelines and 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, MIDD, 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.).
• Assist in process improvement initiatives and SOP development where applicable.