As an Associate Medical Director/Medical Director and member of our Clinical Development team, you will support the planning and execution of full life-cycle development of our antibody-drug conjugates (ADCs) global clinical trials. You will lead all clinical aspects of clinical trials, provide support to the Clinical Trial Team (CTT), ensure patient safety, and support the company in clinical development and in medical aspects of early development. You will be part of a highly collaborative and cross-functional team involved with site evaluation, study start-up, study execution and management, and study close-out of our trials. The ideal candidate will be based in the Munich area, but remote locations in Germany are also acceptable.
Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
Lead development of clinical sections of trial and program level regulatory documents such as protocol & amendments, imaging/pathology/DSMB charters, briefing books, BLA/MAA, ODD, breakthrough applications etc.
Act as clinical lead within the clinical trial team (CTT) and support the other CTT functions such as biostats/DM/Pharmacology/PV/Clinical operations etc.
Execute the clinical development strategy in accordance with GCP, ICH (International Conference of Harmonization), and Competent Authority regulations.
Support the Clinical Development leadership team in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues (eg provide clinical input to DSURs).
Support the Clinical Development leadership by providing medical input into the Clinical Development Plan.
Strong track record of working within clinical teams in global Phase I-IV trials.
~ Holds a working knowledge of oncology with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trials.
~ Global mindset : Work in an international, diverse team.