Director, Quantitative Clinical Pharmacology

Location
United States
Salary
Highly Competitive Package Offered
Posted
19 Sep 2019
Closes
19 Oct 2019
Ref
IKDQCP-18686
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Are you an experienced Clinical Pharmacologist with a strong command of quantitative modelling, and pharmacometrics? I am currently working with a market leading, global pharma currently seeking expansion within their Clinical Pharmacology strategic team in the US. You will be taking on key responsibilities as a project representative for both Clinical Pharmacology and MBDD, whilst working within a strong scientific pipeline. This position would be ideal for those with an expertise in this field, looking to take on further responsibilities within a multi-therapeutic environment.


Position:

As a Director, Quantitative Clinical Pharmacology you will:

  • Apply your Clinical Pharmacology expertise to the ongoing drug development within a range of key therapeutic areas, including both small molecules and biologics.
  • Lead the Clinical Pharmacology component of the Clinical Development Plan
  • Design and interpret studies within early, full and life cycle stages of development.  
  • Develop and implement an effective quantitative strategy, to ensure of appropriate PBPK and PKPD analysis. 
  • Provide contributions to Clinical Pharmacology strategy within both early and late stage projects, and be responsible for the design and execution of Clinical Pharmacology and modelling and simulation plans.
  • Contribute to the preclinical aspects within studies, ensuring the quantitative mechanistic knowledge is sound, and supports human application.
  • Provide subject matter expertise within cross functional teams, alongside health authority interactions and regulatory submissions. Collaborate with colleagues to provide quantitative pharmacology support within First-in-human dose selection and study design.

 Qualifications:

  • A PhD or PharmD within a relevant discipline
  • Various levels of experience will be considered, and a minimum of 8+ year’s post-educational experience would be required.
  • Strong experience within Clinical Pharmacology, alongside hands-on knowledge of PK and PKPD modelling, using a range of software, such as NonMem, Monolix and R etc.
  • Demonstrated leadership skills are desired.
  • Experience handling submission reports within regulatory documents, and handling responses to health authorities.

If you feel like this could be a great opportunity for your career, then please do get in touch. I am reachable on +44 (0)1293 584 300, or email a copy of your CV to ian.kulka@rbwconsulting.com. If this position does not quite hit the mark, then please get in touch to discuss your industry options.

 

Keywords:

Clinical Pharmacology, Protocol design, submission, Pharmacometric, Leader, Modelling, Nonlinear, pharmacometry, simulation, systems, Biology, biological, pathways, mechanism, pharmacokinetics, pharmacodynamics, Clinical, NonMEM, R, Monolix, PKPD, PK/PD, “Pop PK”, modeller, strategy, strategic, Directorial, leader, quantitative

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