PhD scientist as In vivo DMPK Expert, Study director - Lab Leader (f/m/d)

 Nuvisan GmbH  Grafing near Munich

In vivo DMPK Expert -Lab Leader (f/m/d)

Grafing, Deutschland
For our DMPK expert Center at Grafing near Munich, we are looking for a highly motivated PhD scientist as in-vivo DMPK Expert, to join our Nuvisan DMPK team in Grafing near Munich. You will act as DMPK Expert/Study Director for our in-vivo DMPK studies and provide DMPK expertise to our client drug development plans. Together with management you will develop the Grafing site into a leading European non-clinical DMPK service organization. If you are someone with excellent experiences in in-vivo DMPK, conducting this role might be a great opportunity for you.

RESPONSIBILITIES

  • Lead a non-clinical in-vivo DMPK team consisting of lab-heads and bench scientists
  • In the role of Study Director / Principal Investigator take responsibility for planning, performance, evaluation, and reporting of in-vivo DMPK studies during drug discovery and development in suitable quality and in accordance with pre-defined capacity and time frame, studies such as PK studies, mass balance and metabolism studies, QWBA and some other specialty studies
  • Provide in-vitro/in-vivo metabolism/ADME expertise to client drug development plans, as required prepare non-clinical gap analyses
  • Conduct interim DMPK analyses, interpret the data and attend teleconferences to discuss study progression with customers
  • Support the non-clinical DMPK business development representatives with scientific input, proposal activities and presentations, along with representing the department during client visits and audits
  • Be responsible for compliance with German law, appropriate Nuvisan SOPs, GxP guidelines and other applicable regulation

QUALIFICATIONS

  • PhD in pharmaceutical sciences, analytical chemistry, veterinary medicine or pharmacist with 5 to 7 years of experiences in small molecule drug development in pharma industry or CRO
  • Have an excellent understanding with hand on experience of pharmacokinetics and drug metabolism and how to position the in vivo data in relation to clinical development plans.
  • Experience with Phoenix WinNonLin
  • Experience with in-vitro drug metabolism is an asset
  • Experience in Laboratory Animal Science at FELASA C level is advantageous
  • Effective interpersonal and communication skills
  • Cooperative, self-motivated, with a can- do attitude
  • The ability to work to tight deadlines while maintaining high standards
  • Assume responsibility as deputy principal investigator according to German animal welfare laws for all animal studies
  • A good understanding of working with radioactivity in support of mass balance and metabolite identification studies
  • Experiences to work in a GLP accredited environment and adherences to corporate and health authority quality standards and guidelines
  • Your excellent command of written and spoken English and German will enable you to act in an international working environment

ABOUT YOU

If you are looking for a challenge and opportunity to bring in your expertise and passion for DMPK into our high quality DMPK services and to impact our client drug development plans, this position might be of your interest.

What's great in the job?

Are you ready for the challenging and exciting work within an international team in a well-established but also fast growing CRO?Are you seeking for an employer who is able to provide you with exciting development opportunities within the company? We offer a competitive salary and benefit package.

The NUVISAN Group is an internationally successful Contract Research Organisation (CRO) which performs drug trials for international pharmaceutical companies, biotech and generic manufacturers. A complete range of clinical drug development services can be offered as a package including non-clinical services, bioanalytics, biopharmaceuticals, pharmaceutical analysis, stability testing and clinical trial manufacturing and packaging.

Founded in Germany in 1979, NUVISAN’s 420 highly qualified staff provide analytics and clinical studies sponsored by the pharmaceutical industry.


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About Nuvisan GmbH

Die NUVISAN-Gruppe ist eine international erfolgreich tätige Contract Research Organisation (CRO), die für internationale Arzneimittelun­ternehmen, Generikaherstel­ler und Biotech-Unternehmen Arzneimittelstudien durch­führt. Zusammen mit Non-Clinical Services, der Bioanalytik, den Bio-Pharmazeutika, der Pharmazeutischen Analytik, der Stabilitätsprüfung sowie der Prüfmusterherstellung...
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