Associate Director / Director Clinical Pharmacology

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.

Benefits

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Sobi? Share your experience