In this role, you will be responsible for designing, conducting, and analyzing complex pharmacokinetic and pharmacodynamic studies to support drug development across various therapeutic areas. You will work closely with cross-functional teams to ensure the success of both preclinical and clinical development programs.
Key Responsibilities:
- Modeling and Simulation: Develop and implement population pharmacokinetic (popPK) and pharmacodynamic (PD) models using advanced modeling and simulation techniques to optimize drug development strategies.
- Data Analysis and Interpretation: Analyze and interpret PK/PD data, including clinical trial results, and provide insights to guide decision-making for drug development.
- Collaboration: Work closely with preclinical, clinical, and regulatory teams to support the design, execution, and interpretation of clinical pharmacology studies.
- Study Design: Contribute to the design of clinical and preclinical studies, including dose escalation studies, clinical trials, and bioavailability assessments, to ensure appropriate study design and data collection.
- Regulatory Submissions: Prepare and review regulatory submissions, including INDs, NDAs, and other regulatory documents, ensuring that PK/PD data is presented accurately and effectively.
- Innovation and Methodology: Stay up-to-date with the latest advancements in PK/PD modeling, simulation technologies, and regulatory requirements, applying this knowledge to improve internal processes and modeling techniques.
- Mentoring and Leadership: Provide guidance and mentorship to junior scientists and contribute to the growth and development of the team's skillset.
Qualifications:
- PhD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or a related field, with at least 5-7 years of industry experience in PK/PD modeling and simulation.
- Expertise in population pharmacokinetics and pharmacodynamics, including the use of modeling software such as NONMEM, Phoenix WinNonlin, or similar platforms.
- Strong understanding of clinical pharmacology, including study design, regulatory guidelines, and data interpretation.
- Experience in applying PK/PD modeling to support drug development across early- to late-stage clinical trials.
- Excellent communication skills, with the ability to present complex data and concepts to both technical and non-technical audiences.
