Associate Director / Director Clinical Pharmacology — Sobi

Role overview

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 considered and that pre-clinical and clinical PK/PD information are optimally used and integrated into development plans.

• Contribute and decide on the biomarker strategy in clinical programs.

• Contribute to the clinical development plan.

• Responsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities.

• Represent clinical pharmacology on project Core Teams.