Associate Director, Clinical Pharmacology And Pharmacometrics

Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Titusville, 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/ .

The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex 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 Associate Director (AD) CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT). The AD CPP leader can independently drive the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.

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.

• 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.

• Provide mentorship to CP colleagues on hands-on aspects of clinical pharmacology.

• Drive early alignment on key development questions where CP principles could be applied.

• Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.

• Lead the integration of input from all relevant functions as well as the preferred sourcing partners to formulate an efficient execution plan.

• Ensure access to optimum capabilities including resourcing for CP studies, developing sustainable strategy to acquire or develop internally all necessary CP techniques that are aligned with the disease area of interest to Janssen R&D.

• Acquire or develop internally, tools and training to enable identification and development of question-based drug development opportunities.