A career with EMD Serono is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your role:
New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific and operational role in Research and Development (R&D).We are 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 managing the overall DMPK contributions to specific NBE projects, from molecule design through Life Cycle Management (LCM), thus fulfilling internal and regulatory requirements. You will define and refine the appropriate DMPK strategy for each molecule, including PK strategies to de-risk the clinical development plan, communicating bioanalytical strategies both preclinically and clinically, and immunogenicity risk assessments (IRAs), and for ensuring that studies are conducted on time and with the required quality. You will also be responsible for defining the appropriate M&S approach during the early discovery phases for assigned NBE molecules, which could include literature mining, model building and refinement, translation of the M&S findings to answer relevant research questions, and integration of all existing knowledge on the NBE molecule and relevant processes to acquire meaningful and research question-oriented M&S insights. You will also be able to qualitatively and quantitatively integrate the various bioanalytical and immunogenicity data to interpret drug disposition (pharmacokinetics and PK/PD) guiding engineering strategies and optimization of therapeutics. The NBE DMPK Lead is a member of the Discovery or Global Project Team, depending on the phase of the project, and as scientific matter expert on subteams. You will represent the NBE DMPK function on these teams and ensure that the proper flow of information between the project, the function, and key stakeholders is in place. You will ensure that studies within the NBE DMPK responsibility of the given project are conducted according to the agreed timelines and the required quality and you will be accountable for DMPK contributions to international health authority submissions
Who You Are:
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