Responsibilities
- Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.
- Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.
- Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.
- Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
- Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.
- Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
- Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.
- Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.
- Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.
Requirements
- PhD preferred with specialty training in Pharmacometrics, appropriate MS or PharmD also applicable
- Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required.
- The understanding and ability to communicate and apply MIDD strategies to drug development.
- Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.
- Experience in the successful use of MIDD to support drug development decision making
- Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field
- Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.
- Leadership of a team with various backgrounds and skills in pharmacometrics.
- Experience of developing individuals pharmacometric and communication skills and talents
- Proficient in MS Office Suite.
- Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.
