Responsibilities:
- Manage a team in one or more therapeutic focus areas; ensure successful and timely completion of QP activities and deliverables supporting Drug Safety and Pharmacometrics.
- Support assets from Early Clinical Development through submission and beyond.
- Manage and mentor individual contributing scientists; provide technical guidance across the organization.
- Lead performance management, assessment, guidance, and training.
- Use expert PK/PD knowledge and strategic leadership to develop and implement strategic analyses for R&D projects.
- Take accountability for PK/PD evaluation across a product/project portfolio or highly complex, broad-scope projects.
- Identify opportunities for process/procedural and product/service improvements.
- Solve unique and complex problems with broad business impact.
Qualifications:
- 10+ years industry experience with a Ph.D. or 12+ years with an M.S. in modeling/simulation, PK/PD, systems pharmacology, and quantitative drug development strategies.
- Hands-on use of quantitative tools and systems; strong publication record.
- Excellent written and oral communication; ability to convey complex information succinctly.
- Strong collaboration; build alliances across functions; influence multi-disciplinary teams.
- Ability to handle all types of projects and leverage senior staff for technical input/brainstorming.
- Proven experience interacting with regulatory agencies without supervision; develop regulatory strategy.