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Associate Director, Experimental Medicine

Eingestellt von Bio Careers

Gesuchte Skills: Design, Support


Job Summary: We are currently seeking a Associate Director, Experimental Medicine for our Edison, New Jersey location. This position will design and support conduct of early phase clinical studies for assessing product pharmacology and safety including first-in-human single-dose ascending and repeat-dose ascending, no-product enabling/methodology, and 'Phase 0'studies such as microdosing and Exploratory IND (referred to as "Translational Medicine Phase 1 studies"), and other pharmacodynamic healthy volunteer and patient "Phase Ib" studies. Responsibilities: In this role, the incumbent leads Experimental Medicine studies including First in Human, Phase 1, and Proof of Mechanism (PoM) studies, as well as non-product clinical studies supporting biomarker development and validation; lead Experimental Medicine studies, including First in Human, Phase 1, and Proof of Mechanism (PoM) studies, as well as non-product clinical studies supporting biomarker development and validation. Ensure that pharmacokinetic, biomarker, pharmacogenomic and clinical endpoints are correctly incorporated. The role will be responsible for ensuring that input from relevant TMCP functions and other functional groups within Daiichi Sankyo is gathered and correctly incorporated into study profiles. Participate, and at times organize project-related Advisory Board Meetings. Develop protocol synopsis and oversee protocol writing, clinical study conduct, data analysis / interpretation and report generation. Collaborate with supporting functions such as Study Logistics, Data Management and Biostatistics to ensure timely data base lock, analysis and reporting of Experimental Medicine Phase 1 studies within the project timelines. Represent TMCP on, and at times lead, Operational Project Teams. In addition to study leadership roles, Operational Project Team deliverables include preparation, submission, and updating of Investigator Brochures and of IND/CTA dossiers. Develop budget estimates and manage budget for Experimental Medicine studies. If medically qualified, also responsible for medical monitoring as well as medical review of additional TM/CP projects, including assessment of subject risk/benefit. Qualified candidates must have a MD or PhD in Life Sciences and at least 3 years of academic or 2 year of pharmaceutical industry experience (preferably in experimental medicine, translational medicine, or clinical pharmacology), with experience in a role having primary responsibility for design and conduct of Phase 1 study protocols. Experience across multiple therapeutic areas is very desirable. The incumbent must have had personal experience and involvement within project teams in issues around design and conduct of Phase 1 studies. Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies. Ability to collaborate with interdisciplinary functions within and outside Daiichi Sankyo on effective set up and execution of Experimental Medicine Phase 1 studies. Must be willing to travel 20% of the time.


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Geforderte Qualifikationen

Bio Careers