DMPK Director
Location: GermanySIRE Life Sciences® is a recruitment and executive search consultancy, dedicated exclusively to the European Life Science industry. SIRE Life Sciences® provides a Complete Life Science Cycle Search Solution to both Life Science Professionals and Life Science Employers operating in the European Life Science Sector. We provide a tailor made European wide service for both permanent and freelance solutions, specialized in delivering to the world's leading Life Science institutions.
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Germany.
My client is a world leading pharmaceutical company. For their DMPK projects they're currently looking for an experienced DMPK Director
ROLE DESCRIPTION
Global DMPK Director
RESPONSIBILITIES
- Independently and in cooperation with CROs; design pharmacokinetic (PK), anti-drug antibody (ADA) and neutralizing antibody (nAB) assays for large biological molecules as required
- Develop and validate state-of-the-art assays to fulfil regulatory requirements for BLA/MAA
- Analyze, interpret and compile bioanalytical study data for presentations, reports and regulatory submissions
- Plan and oversee relevant assay and reagent development activities
- Develop expertise in immunogenicity, integrate into the Biosciences department and take over non-clinical team-responsibilities for development projects in cross-functional international teams
- Support the team in designing non-clinical and clinical PK and immunogenicity studies
- Support the team in questions of pharmacology/immunology
- Manage the outsourced DMPK studies (strategy, contract, process, results) and contribute to time line and budget creation
REQUIREMENTS
- Masters degree (e.g. MBA, MSc) or Doctoral degree (e.g. PhD, MD) in Biochemistry, Biology or other relevant discipline
- Experience in immunoassay development including ELISA, ECL, MSD and/or cell-based assays
- Broad knowledge in the field and appropriate level of understanding of applicable regulations for assay validation
- Academic and/or technical background in immunoassay development for proteins and/or antibodies
- Experience with managing CRO interfaces
- Background in the pharmacology of antibodies
- Excellent command of written and spoken English
- Leading Teams (up to 15 specialists)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robbert Roos.
