NBE DMPK Lead (all genders)

Posté 19 avr. 2024

Darmstadt, Hessen - Germany

Demander un identifiant 274139

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


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).  Healthcare 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 managing the overall DMPK contributions to specific biotherapeutic projects, including antibody drug conjugates (ADCs) and other biologics, from molecule design through Life Cycle Management (LCM), thus fulfilling internal and regulatory requirements. An important requirement is having a broad experience in leading projects, a proven track record in DMPK, and expertise with modelling and simulation, as well as a modality agnostic, expert understanding of the different approaches related to PK. As required per project, you will define and refine the appropriate strategy for each molecule, including PK strategies to de-risk the clinical development plan, bioanalytical strategies both preclinically and clinically, M&S strategies, and for ensuring that studies are conducted on time and with the required quality. You should also be able to integrate the various bioanalytical and immunogenicity data to interpret drug disposition (pharmacokinetics and PK/PD) to guide engineering and optimization strategies of our biotherapeutics. Understanding bioanalytical sciences, particularly in immunogenicity risk assessments and testing strategies during discovery, development, and approval/post-approval activities, is important. The NBE DMPK Lead is a member of the Discovery or Global Project Team, depending on the phase of the project, or due diligence teams as needed, and a scientific matter expert on teams, representing the NBE DMPK function on these teams and ensuring 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 contributions to international health authority submissions. The role will be based in Italy or Germany.

 

Who you are:

  • Ph.D. in Pharmacokinetics/Pharmacodynamics, Pharmacometrics or a related field.
  • Experience in PK/PD or PBPK modeling preferred (incl. knowledge in relevant software, e.g. NONMEM, R, Phoenix WinNonLin).
  • Several years of professional experience in drug discovery and development (>7 years), with excellent knowledge of discovery and development processes and workflows.
  • Solid understanding of translational sciences, regulatory requirements, and work packages (nonclinical and clinical). Experience with biological drug candidates is a plus.
  • Expertise in immunogenicity, DMPK, bioanalytical sciences, and/or related sciences, in both the preclinical and clinical stages of drug discovery/development, is preferred.
  • General knowledge of disease areas (e.g. Immunology, Oncology, etc.), and in-depth understanding of biology and pharmacology.
  • Excellent organizational skills and communication skills; fluent spoken and written English, German or Italian is a plus.
  • Excellent inter-cultural understanding.
  • Strong mature leadership and influencing skills.
     

 



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

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