Associate Director / Director Clinical Pharmacology

Key Responsibilities

• Overall accountability for quantitative clinical pharmacology strategies and activities in appointed clinical projects with focus on late-stage development including filing and life-cycle management.
• Define appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD, exposure-response, and M&S in clinical development plans that enable clinical development and regulatory decisions.
• Provide 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.
• Provide expert knowledge on clinical pharmacology and communicate clinical pharmacology aspects internally and during health authority interactions.
• Oversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant.
• Ensure that translational aspects are cons...