The Director of Pharmacometrics will play a crucial role in optimizing dosing regimens, ensuring regulatory compliance, and contributing to the overall success of therapeutic projects.
Key Responsibilities:
- Lead and oversee the development and application of pharmacometric models to support drug development and regulatory submissions.
- Collaborate with clinical pharmacology, biostatistics, and other interdisciplinary teams to inform clinical trial designs and data analysis.
- Develop and implement model-based strategies to optimize dosing regimens and therapeutic outcomes.
- Ensure the accuracy and quality of pharmacometric analyses and reports.
- Mentor and provide scientific guidance to a team of pharmacometricians and other scientific staff.
- Engage with regulatory agencies and prepare regulatory submission documents related to pharmacometric analyses.
- Stay abreast of the latest developments in pharmacometrics and incorporate new methodologies and technologies as appropriate.
- Present findings and strategies to senior management and cross-functional teams.
- Develop and maintain standard operating procedures (SOPs) for pharmacometric activities.
Qualifications:
- PhD in pharmacometrics, pharmaceutical sciences, pharmacokinetics, or a related field.
- Extensive experience with non-linear mixed effects modeling.
- Proven track record of successful regulatory submissions involving pharmacometric analyses.
- Excellent leadership and mentoring skills.
- Strong publication record in peer-reviewed journals.
- Experience with software tools like NONMEM, Monolix, or similar platforms.
- Exceptional communication and collaboration skills.
Preferred Skills:
- Strong analytical and problem-solving abilities.
- Ability to work effectively in a fast-paced, dynamic environment.
- Experience in managing multiple projects simultaneously.
- Familiarity with the latest advancements in pharmacometric methodologies and technologies.
