Novartis-posted 2 months ago
$145,600 - $270,400/Yr
Full-time • Senior
Hybrid • Cambridge, MA
Chemical Manufacturing

We are 60 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As the Associate Director Pharmacometrics, you will drive the pharmacometric strategy for clinical programs in multiple indications or a disease area. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for addressing pharmacometric issues in regulatory submissions and integrated evidence generation directly influencing drug development decisions with internal and external partners.

  • Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge.
  • Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results.
  • Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies.
  • Lead and optimize the provision of pharmacometric contributions to regulatory/submission strategy and related documents.
  • Represent the Global Project Teams internally and externally, including interactions with Health Authorities and external key opinion leaders.
  • Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards.
  • Identify alternative strategic options to mitigate risk on clinical programs.
  • Contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using varied data sources, including Real World Data.
  • Ensure that the Analytics team are aligned on the pharmacometrics strategy, execution, and delivery of assigned projects.
  • Represent PMX in due-diligence teams to evaluate in-licensing opportunities.
  • Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent) with 6+ years' experience in clinical drug development applying model-based methods.
  • Experience using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation.
  • Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas.
  • Diverse experience in pharma industry on incorporation of MIDD strategies into drug development plans across all phases.
  • Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics.
  • Internally and externally established track record of developing/establishing pharmacometrics excellence.
  • Scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy.
  • Track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies.
  • Health, life and disability benefits.
  • 401(k) with company contribution and match.
  • Generous time off package including vacation, personal days, holidays and other leaves.
  • Performance-based cash incentive.
  • Eligibility for annual equity awards.
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