Director/Sr Director Pharmacometrics
BioSpace · Indianapolis, IN · 4 wk ago
Healthcare$177k–$308k/yrFull-time
About the role
The Director/Sr Director Pharmacometrics role is designed for a scientist ready to operate as an enterprise-level scientific leader. The role is expected to define which scientific problems matter (not just to solve them) and to shape PMx strategy across programs, platforms, and the broader organization. This is a high-visibility role with direct influence on drug development decisions, regulatory interactions, and team capability-building.
Responsibilities
- Champion MIDD approaches across programs and platforms, defining and delivering novel PMx strategies that shape drug development decisions.
- Resolve complex technical and scientific challenges with cross-program impact, contributing to exposure-response, dose justification, and regulatory submission strategies in collaboration with PKPD lead and across functions.
- Engage proactively with regulatory agencies through meetings, responses, and advisory interactions.
- Partner with cross-functional leaders, PKPD colleagues, and senior partners, serving as a trusted scientific partner whose input is actively sought.
- Create the conditions for others to succeed: share knowledge generously, open doors, and actively invest in bench strength and organizational capability.
- Champion adoption of automation tools and AI/ML approaches that deliver pragmatic, scalable value across the department and beyond.
- Build PMx’s external reputation through publications and scientific leadership in industry and regulatory forums.
- Communicate complex science with executive presence to diverse audiences, from project teams to senior leadership.
Qualifications
- PhD in a relevant scientific field such as PMx, biological/pharmaceutical sciences, bioengineering, biostatistics, computer science/engineering, data science, or a related discipline. With 5 years post PhD experience.
- Experience in population PKPD modeling, across multiple programs or development phases.
- Experience in NONMEM and/or Monolix, and R.
Additional Skills & Preferences
- Experience with mrgsolve, Julia, Phoenix NLME, and/or MATLAB is highly valued.
- Demonstrated ability to translate quantitative modeling outputs into clear scientific and regulatory narratives for cross-functional and non-specialist audiences.
- Proven track record of influencing drug development decisions and regulatory strategy through PMx analyses, with evidence of impact beyond a single project.
- MIDD Experience shaping technical strategy across programs or platforms, including involvement in regulatory submissions, health authority interactions, or cross-functional governance bodies.
- Strong mentorship and coaching skills, with experience developing the capabilities of more junior scientists.
- Active engagement with AI and automation in a PMx context, including hands-on experience with tools, a genuine curiosity for what's possible, and the judgment to translate innovation into practical scientific value.