Senior Modeling and Simulation Scientist (Billerica MA)

EMD Serono Research & Development Institute•Billerica, MA

5d•$142,700 - $214,100•Onsite

About The Position

New Biological Entities Drug Metabolism and Pharmacokinetics Modeling and Simulation (NBE DMPK M&S) Expert is a scientific, strategic, and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics. You will be responsible for M&S project support from concept to late discovery/early development. You will ensure project teams take data-driven decisions by applying models to inform drug design, drive optimal pre-clinical in vivo study design, consult on best in vitro study design, assess feasibility of different routes of administration, define required formulation concentrations, and thereby increase the probability of success of projects early on. The molecules you will design are multi-specific biologics (including NBEs and ADCs) with non-linear PK/PD relations requiring early quantitative assessment and creative approaches for optimal multi-variate molecular design, and translation of PK and efficacy for human dose predictions. You will ensure that M&S strategies are in line with project team needs and expectations, clearly communicating risks and data gaps, as well as mitigation options. You will ensure results are delivered according to agreed timelines, balancing the resources required and high quality, impactful deliverables. We are looking for an individual with a proven track record of applying modelling and simulation approaches to biological problems and ideally experience in quantitative pharmacology & pharmacokinetics. The NBE DMPK M&S expert may also be a member of the Discovery Project Team, depending on the phase of the project. As scientific matter expert, you will also contribute to and may lead scientific initiatives designed to improve the M&S capabilities within our drug discovery organization.

Requirements

Ph.D./Post-Doc preferably with experience in pharmaceutical/biotechnological industry
Education in either Systems Biology, Pharmacokinetics, Pharmaceutical/ Biotechnological Sciences, Biomedical/Chemical Engineering, Applied Mathematics, or a related discipline.
Proven track record of applying modelling and simulation approaches to biological problems
Experience in quantitative pharmacology & pharmacokinetics
Fluent spoken and written English

Nice To Haves

Comprehensive understanding of the concepts of pharmacokinetics and pharmacodynamics during drug discovery & development
Strong hands-on experience with modeling software (such as: MatLab SimBiology, R/RxODE, Open Systems Pharmacology Phoenix/WinNonlin, NONMEM, Monolix etc).
Experience with the application of mPBPK and QSP models.
Experience in Python, C/C++ and/or other programming languages would be advantageous.
Good understanding of related disciplines (pharmacology, toxicology, nonclinical safety, drug design, bioanalytics, etc.) is desirable.
German or Italian is a plus.

Responsibilities

M&S project support from concept to late discovery/early development
Ensure project teams take data-driven decisions by applying models to inform drug design
Drive optimal pre-clinical in vivo study design
Consult on best in vitro study design
Assess feasibility of different routes of administration
Define required formulation concentrations
Increase the probability of success of projects early on
Ensure M&S strategies are in line with project team needs and expectations
Clearly communicate risks and data gaps, as well as mitigation options
Ensure results are delivered according to agreed timelines, balancing the resources required and high quality, impactful deliverables
Contribute to and may lead scientific initiatives designed to improve the M&S capabilities within our drug discovery organization