NBE DMPK Lead
EMD Serono


Job Info


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:

Required:

  • Ph.D. in Pharmacokinetics/Pharmacodynamics, Pharmacometrics or related field.
  • Experience with biological molecules (NBEs, ADCs, other novel modalities).
  • Several years of professional experience in drug discovery/development (>5 years), with excellent knowledge of drug development & discovery processes and workflows.
  • Solid understanding of immunogenicity, DMPK, NBE bioanalytics and related method of analyses, and related sciences.
  • Solid understanding of translational sciences, regulatory requirements and NBE work packages (non-clinical and clinical).
  • General knowledge of disease areas (e.g. Immunology, Oncology, etc.), more in-depth understanding of biology, pharmacology.
  • Excellent organizational skills and communication skills; fluent spoken and written English.
  • Excellent inter-cultural understanding.
  • Strong mature leadership and influencing skills.
Preferred:
  • Experience in PK/PD or PBPK modeling preferred (incl. knowledge in relevant software, e.g. NONMEM, R, Phoenix WinNonLin).
  • German fluency is a plus.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 215636

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time



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