Pharmacometrics Lead

This role will combine strong pharmacometric skills with a deep biological 
understanding. They are responsible for independently determining, planning, 
and executing M&S analyses for an entire drug development program in close 
collaboration with cross-functional colleagues within the R&D organization. 
Specific experience and interest in working in population PK/PD or quantitative 
systems pharmacology is required. This role determines, plans, and executes 
technically challenging analyses by using state of the art Modeling & 
Simulation methodologies to strongly contribute to critical decision making. 
This role will lead M&S projects for an entire drug development program to 
evaluate study design, dose selection, probability of success estimation, 
portfolio strategy, pediatric extrapolation etc. In this role, it is expected 
that they will represent M&S with cross-functional drug development teams, 
proactively advocate for model-based approaches, and clearly communicate M&S 
results.

KEY RESPONSIBILITIES:
Independently determines, plans, executes, and interprets modeling analyses for 
an entire drug development program aligned with the program strategy
Closely collaborates with the Modeling & Simulations senior director
Represents M&S on cross-functional drug development teams, proactively 
advocating model-based approaches to address development challenges
By using state of the art Modeling & Simulation methodologies strongly 
contribute to decision making at critical milestones based on quantitative 
principles in close collaboration with Biostats, Clin Pharm and other 
quantitative disciplines
Represents M&S in preparation for regulatory responses and external regulatory 
interactions
Represents the department in company-wide, non-scientific initiatives
Proactively incorporates and develops approaches and methodologies based on 
review of relevant scientific literature
Supervise and mentor junior scientists
Perform population PK, PKPD-analyses, Clinical trial simulations and other 
model based analyses on a regular basis
Coordinate outsourced Modeling & Simulation activities when appropriate
Strengthen our internal Modeling & Simulation capability on a continuous basis 
by initiating training activities, evaluating and incorporating new M&S tools 
as appropriate.
Demonstrate effective communication and leadership to a broad audience with 
diverse backgrounds, including senior management

PREFERRED EDUCATION AND EXPERIENCE:
PhD in Pharmaceutics, Clinical pharmacology, or other quantitative discipline 
with an emphasis Pharmacometric methodologies
Industry experience in the application of Pharmacometrics within the context of 
drug development is required.
Expert hands-on skills from population-based PKPD modeling, Clinical trial 
simulation and optimal design, probability of success calculations, Disease 
progression modeling, Meta analyses etc.
A solid understanding of fundamental pharmacokinetic and quantitative 
pharmacology (PKPD) principles.
Excellent programming skills (NonMem, R, Phoenix, SAS and other similar tools)
Demonstrated strong leadership- and influencing skills
Excellent collaborative, verbal and written communication skills
Experience from Regulatory interactions and guidelines relevant for M&S

TJ Elder
Search Consultant
Pre-Clinical Development
O: 413.458.6124
C: 413.207.7676
https://www.linkedin.com/in/tjelder/
tel...@stem-sourcing.com<mailto:tel...@stem-sourcing.com>


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