You would have the responsibility for:
• Developing DMPK project strategies and proposals and present these to the project teams and management board.
• Lead the DMPK team to ensure smooth planning and conduct of studies in preparation and follow-up of project team decisions.
• Supervise or perform human PKPD and dose predictions based upon preclinical in vivo and in vitro data to support clinical dose selection and trial design.
• Evaluation of clinical PK data, including simulation of different dosing scenarios/populations.
• Be member of the clinical project group. Prepare DMPK project and compound documentation such as internal reports, regulatory documents e.g., IMPD, IND and Investigator brochure. Active participation in interactions with regulatory authorities including meetings and correspondence, relating to ADME/DMPK matters.
• Collaborate as leader and/or team member in multidisciplinary teams on drug development topics.
• Responsible for planning, coordination and evaluation of DMPK studies performed in house in close collaboration with the members of the DMPK team.
• Responsible for planning of DMPK studies externally at contract laboratories (CROs) worldwide through establishing contact and close collaboration via email contact and video meetings. Responsible for reviewing the results and reports of such studies.
• Share knowledge and lessons learned in the DMPK team and company.