Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Associate Director to be located in Raritan, NJ or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visithttp://www.JanssenRnD.comfor more information.
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The position is responsible for developing and directing pharmacometrics activities, deliverables, and programs for assigned products in various stages of development ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. As a Pharmacometrics Leader, the position will apply Model-informed Drug Development (MIDD) approaches to assigned programs within a Therapeutic Area. The responsibilities of this position also include close collaboration with clinical pharmacology lead and statistics lead and active participation on pertinent Project Matrix Team, Clinical Teams (CTs), Compound Development Teams (CDTs), and other project teams across all phases of drug development. The Associate Director role would include: With minimal guidance from Pharmacometrics Group Lead, develop and implement Model-informed Drug Development (MIDD) pharmacometrics plans and strategies for products in all stages of Drug Development Perform on modeling and simulation of dose- and exposure-response (PD, toxicity, and safety endpoints) to guide starting dose, dose regimen, and dose range for FIH, MAD, PoC, Phase 2b, and Phase 3 trials Work collaboratively with key functional partners and apply quantitative ClinPharm tools to guide NME selection, dose / dose regimen selection, predict clinical response and study outcomes, and to optimize study design With minimal guidance from Pharmacometrics Group Lead, prepare Pharmacometrics contributions to regulatory documents including IBs, End of Phase 2a/2 meetings, NDA / MAA submissions, post-approval filings, and responses to regulatory questions As appropriate, represent Pharmacometrics at relevant regulatory meetings (eg, End of Phase 2a/2, pre-NDA/MAA, Advisory Committee meetings) As requested, participate in the evaluation of potential in-licensing opportunities Present and / or publish scientific data at conferences and in peer-reviewed journals Stay abreast of new emerging technologies in relevant scientific fields Liaise with key functional partners to provide product differentiation strategies based on a compound’s key attribute Responsible for the consistency, quality, compliance, and timeliness of Pharmacometrics input into Phase 1 to 3 protocols, Pharmacometrics analyses, Development Plans, and relevant sections of IBs, CSRs, regulatory, and other documents in accordance with applicable SOPs, guidelines, and regulatory requirements Contribute to process-related initiatives within Pharmacometrics department Provide leadership, direction, and mentoring to junior Pharmacometrics staff Strengthen partnerships, teamwork, and communication across functional units within one’s area of responsibility Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity
- PhD, or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences or related discipline with a minimum of 6 years pharmaceutical development experience OR a MS or Pharm D degree in Pharmaceutical Sciences, Clinical Pharmacology, Biological Sciences or a related discipline with a minimum of 8 years pharmaceutical development experience is required
- Excellent hands-on knowledge of PK & PD Nonlinear Mixed effect modeling software packages (NONMEM / Monolix / Matlab) is required
- Excellent hands-on knowledge of data handling packages (SPLUS / R / SAS) is required
- Demonstrated understanding of MIDD and biostatistics principles and tools and demonstrated ability to apply these tools to enable rational and efficient drug development is required
- Demonstrated understanding of PK, PD, PK/PD, ClinPharm, and Translational Medicine is required
- Good understanding of clinical drug development and the overall pharmaceutical R&D process is required
- Working knowledge of US, European, and Asian regulatory requirements and guidelines is required
- Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
- Ability to lead and / or oversee multiple smaller pharmacometrics programs is required
- Has established a good level of expertise and scientific reputation through publications and presentations is required
Primary LocationNorth America-United States-Pennsylvania-Spring HouseOrganizationJanssen Research & Development, LLC. (6084)TravelYes, 10 % of the TimeJob FunctionPharmacokinetics
Internal ID: 3732171031
Location/Region: Spring House, PA (US)