In charge of designing and executing the PMX strategy at the program level; building, validating, and implementing models for disease, placebo, exposure-response, and mechanistic PKPD to assess risk/benefit and aid in drug development decisions, in close partnership with TS colleagues and other R&D associates.
Key Duties & Responsibilities:
- Spearhead the design and execution of the PMX strategy and other advanced Model Informed Drug Discovery and Development methods (within and/or across programs) to facilitate quantitative decision making throughout the drug development cycles.
- Oversee and conduct pharmacometric analyses internally and/or by external vendors using various tools and methods. Consolidate, interpret, and present results to project teams and other stakeholders.
- Actively contribute to crucial pre-clinical, clinical, and regulatory documents including; clinical study protocols, clinical study reports, modeling reports, investigator brochures, INDs and BLA/NDAs within agreed timelines, complying with all regulatory requirements.
- Foster productive collaboration within drug development teams and with other internal partners (e.g., DMPK, Regulatory Affairs, Clinical Development, and Biostatistics).
- Keep track of timelines, objectives, and budgets. Ensure project and activity progress is accurate. Guarantee swift and effective communication of high-quality data and results to project teams.
- Maintain and improve technical expertise in drug development (e.g., training courses, attendance at external meetings). Initiate training/study sessions within Company's Clinical Pharmacology & Pharmacometrics and for other line functions. Serve as a technical expert in a key clinical pharmacology/DMPK/pharmacometric related area.
- Participate in meetings with internal and external parties including stakeholders, investigators, outside experts, and health authorities.
- Willingness to travel with overnight stays as needed.
For the suitable candidate, remote work environment is an option.
Your Experience & Qualifications Requirements:
- PhD in Clinical Pharmacology/Pharmaceutical Sciences/Pharmacology/Statistics/Engineering with academic training in Pharmacometrics.
- At least 10 years of practical industry experience in Pharmacometrics.
- Experience in more than one therapeutic area and early development.
- Robust quantitative skills and expertise (e.g., experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations).
- Comprehensive understanding of the drug development process.
- Proficient communication and presentation skills.