Client
Our client is an independent, international research based pharmaceutical
company headquartered in Germany. The company's objective is to become the
most patient-centric company in the market whilst also maintaining its
position as a leader in therapy-focused innovation.
Altogether, our client has affiliates in over 35 countries worldwide. Their
products are sold in more than 100 countries and approx. 4,900 employees are
employed globally.
In order to strengthen their team, they are currently looking for a
Pharmacometric Specialist.
Key Responsibilities
* Perform exposure response analyses and knowledge management
activities using internal, literature and summary level data.
* Perform clinical trial simulations, initially focusing on Phase 2a
and 2b studies, but gradually ensuring all studies on the critical path are
simulated (e.g. TS2 simulator) prior to execution in close collaboration
with Clinicians, Statisticians and Pharmacokineticians
* Ensure that data generated are of a sufficient standard for
regulatory submissions.
* Provide feedback to relevant project teams and management meetings
with formal presentations/written reports/verbal input as required.
* Provides effective partnership with peers, through mentorship/advice
on technical issues.
* Keep abreast of development in the field of pharmacometrics, and
ensure peers are kept up-to-date on relevant scientific advances.
* Ensure peer reviews with other Pharmacometrician's, Clinician's,
Statistician's, and Pharmacokineticists
* Contribute to the science of pharmacometrics, investigating and
testing new methodologies that could be applied to drug development.
* Ensure a steady flow of scientific publications and congress
communications.
* Internal and external communications on Modelling & Simulation.
Specific Requirements
* University degree and/or PhD in Modelling/Mathematics and/or Life
Sciences with a focus on Modelling & Simulation.
* Strong academic career and/or post-doc in Modelling & Simulation an
advantage.
* Fluent business English.
* Hands-on experience in pharmaceutical modelling & simulation with
in-depth knowledge of exposure-response modelling.
* Fluency in NONMEM, S+ a.o. M&S software.
* In-depth knowledge of international guidelines and literature.
Strong team player with clear insight into the need for project work and
involvement of colleagues.
* A self-motivator, unafraid to take action and led through behaviour.
* Experience in clinical trial simulation (TS2) ideal.
* Interaction with regulatory authorities (pre-IND, EOP2a, EOP2 etc.)
ideal
* Experience of pain PK/PD modelling an advantage.
* Excellent presentation skills are an advantage.
Our client offers an exciting and challenging role in an international
environment where you can make a difference, learn and grow.
To apply for this position, please send an email explain your suitability
(along with a copy of your most recent CV) to Charlie Allen
([email protected]).
Kindest regards
AspirionPharma