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NBE DMPK Project Representative (all genders)

Your Role: Project Representative, New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) is a strategic, scientific and operational role within Discovery Development and Technologies (DDTech) in Research and Development (R&D).  The successful candidate will be responsible for managing the overall DMPK contributions to NBE projects, from lead optimization through Life Cycle Management (LCM), thus fulfilling internal and regulatory requirements. The incumbent is responsible for defining the appropriate DMPK strategy for each molecule, including PK strategies to de-risk the clinical development plan, 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. They must also be able to qualitatively integrate the various bioanalytical and immunogenicity data to interpret the drug disposition of the NBE and to continuously update the bioanalytical strategies and IRAs as needed for assigned projects. The NBE DMPK project representative also takes the role as member of the Discovery or Global Project Team (DPT or GPT), depending on the phase of the project, and as scientific matter expert on subteams. Represents the DMPK function on these teams and ensures that the proper flow of information between the project, the function, and key stakeholders is in place. Ensures that studies within DMPK responsibility of the given project are conducted according to the agreed timelines and the required quality depending on the stage of the projects. Provides PK assessments for preclinical studies, and supports study monitors for outsourced preclinical and clinical studies to ensure high quality data, and that reports meet applicable international regulatory requirements as well as project timelines.

 

Who you are:

  • PhD in biochemistry, chemistry, immunology, or equivalent training, with industry experience in pharmacokinetics, NBE bioanalysis, and immunogenicity preferred.
  • Several years of professional experience in drug discovery/development (>5 years), with excellent knowledge of drug development & discovery processes and workflows.
  • Working experience in GxP regulated environment.
  • Excellent knowledge of immunogenicity, DMPK, and related sciences.
  • Solid understanding of translational sciences, regulatory requirements and NBE work packages (non-clinical and clinical).
  • General knowledge of NBE bioanalytics and related method of analyses, hands-on experience is a plus.
  • General knowledge of disease areas (e.g. Immunology, Oncology, etc.), more in-depth understanding of biology, pharmacology.
  • General understanding of modeling and simulation approaches for NBE bioanalytics and related method of analyses, hands-on experience is a plus.
  • 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.

 

Job Evaluation: Expert 3

Department: RD-CXSB-U NBE DMPK Project Representat. 

Job Requisition ID:  210343
Location:  Darmstadt
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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