ph3Key Responsibilities /h3ulliOverall accountability for quantitative clinical pharmacology strategies and activities in appointed clinical projects with focus on late-stage development including filing and life-cycle management. /liliDefine appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD, exposure-response, and MS in clinical development plans that enable clinical development and regulatory decisions. /liliProvide matrix leadership to collaborate, align and influence across the cross-functional teams to identify and mitigate key project challenges related to the clinical pharmacology discipline. /liliProvide expert knowledge on clinical pharmacology and communicate clinical pharmacology aspects internally and during health authority interactions. /liliOversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant. /liliEnsure that translational aspects are considered and that pre-clinical and clinical PK/PD information are optimally used and integrated into development plans. /liliContribute and decide on the biomarker strategy in clinical programs. /liliContribute to the clinical development plan. /liliResponsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities. /liliRepresent clinical pharmacology on project Core Teams. /liliContribute to clinical pharmacology evaluations at in-licensing and due-diligence activities. /li /ul /p
