NBE DMPK Lead (all genders)

Posted 06 Jul 2023

Darmstadt, Hessen - Germany

Req Id 265999


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).  We are committed to bring 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, including antibody drug conjugates (ADCs) and other biologics, 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 ensuring there is an appropriate M&S approach during the early discovery phases for assigned NBE molecules, which could include working with experts to support 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 should 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:

  • Ph.D. in Biology, Chemistry, Pharmacokinetics/Pharmacodynamics, Pharmacometrics, or related field.

  • Experience with biological molecules (NBEs, ADCs, other novel modalities).

  • Experience in QSP, PK/PD or PBPK modeling.

  • Artificial intelligence / machine learning are a plus.

  • Expertise in immunogenicity, DMPK, NBE bioanalytics and related method of analyses, and/or related sciences preferred.

  • Several years of professional experience in drug discovery/development (>5 years), with excellent knowledge of drug development & discovery processes and workflows.

  • 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, German 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!

US Equal Employment Opportunities

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.

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