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 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.
• Contribute to clinical pharmacology evaluations at in-licensing and due-diligence activities.

• Ph.D. in relevant scientific area and 8 years of experience in clinical pharmacology (preferably in the pharmaceutical industry) or a minimum of Master´s degree in relevant scientific area with 10 years of experience in clinical pharmacology (preferably in the pharmaceutical industry).
• Solid understanding of the drug-development process and challenges specific to clinical pharmacology.
• Experience with clinical protocol design, in particular clinical pharmacology studies.
• Experience in regulatory submissions and health authority interactions including preparation of relevant documents with regards to clinical pharmacology aspects.

Skills and Competences

• Profound knowledge in PK and PD concepts and their integration into decision making processes of drug development.
• Strong knowledge of state-of-the-art PK and PK/PD modelling and simulation techniques.
• Hands-on experience with PK/PD analysis and modeling software, i.e. Phoenix or equivalent.
• Experience with biologics and small molecules.
• Strong knowledge of regulatory requirements regarding clinical pharmacology.
• Excellent communication and presentation skills
• Fluency in written and spoken English.
• Energetic, driven and able to take initiative with a “can-do attitude”.
• Results and delivery focused as well as a structured way of working.
• Good problem-solving ability and analytical mindset.
• Open, flexible, interested in colleague´s perspectives, team player.
• Strong sense of personal accountability, working independently, as well as a strong ability to work in teams.

All your information will be kept confidential according to EEO guidelines.