Description:
We are seeking a passionate and energetic individual with strong PKPD modeling background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. As a PKPD modeler to support the pharmacometrics functions in the department, you will:
- Establish population PK models to identify intrinsic and extrinsic factors that impact PK, and to guide dose/schedule optimization and recommended phase 2 dose/schedule (RP2Ds) selection.
- Perform model-based simulations to optimize dosing to inform trial designs and clinical outcomes. Ensure quality and integrity of modeling and simulation results.
- Author and provide technical input for regulatory documents and submissions related to all aspects of pharmacometrics (including protocol, IB, briefing package, etc) and responses to regulatory questions.
- Engage and work with consultants and/or CROs on pharmacometrics activities to complement in-house knowledge/expertise and capacities.
Required Skills, Experience, and Education:
- A Ph.D. or Pharm.D. with 5+ years of experience in PKPD Modeling & Simulation.
- Extensive hands-on experience using NONMEM modeling software is a must.
- Familiar with common PKPD/TGI models and able to write customized NONMEM models.
- At least two years of relevant work experience in pharmaceutical companies.
- Proficiency in R programming is desired.
- Able to take dynamically assigned pharmacometrics tasks and deliver the results in a timely manner.
- Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
- A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.
- Demonstrated experience and track record in clinical-stage drug development is a big plus but not required.