Position Summary
- Drive R&D program outcomes by managing and integrating drug development activities across discovery, preclinical research, CMC/clinical manufacturing, regulatory affairs, clinical development, commercial, program strategy, and finance.
Responsibilities
- Lead program teams with integrated strategy, tactical plans, fully integrated schedules, and milestone/decision-point tracking.
- Set priorities/objectives; ensure cross-functional alignment and stakeholder management.
- Optimize project plans (time/resources); coordinate functional execution and manage risks, mitigations, contingencies, issues, and resolutions.
- Maintain proactive, transparent communications; engage internal/external experts as needed.
- Represent the program to senior management; align execution with corporate strategy.
- Resolve conflicts, foster ownership/accountability, and lead ad-hoc cross-functional task forces.
- Ensure program management tools (e.g., Gantt charts), meetings/logistics/documentation, and—when applicable—partner reporting for alliance programs.
Minimum Qualifications
- Life sciences degree; 3–4+ years program management for cross-functional product development.
- (Senior Manager) 10+ years with bachelor’s or 8+ years with advanced degree.
- Leadership in scientific/product development; matrix independence; ability to manage multiple priorities.
- Proficiency: MS Project/Visio/ThinkCell/MS Timeline; MS Word/PowerPoint/Excel.
- Detailed biologics preclinical/early clinical development knowledge; IND/CTA and First-In-Human regulatory understanding.
- Familiarity with cell/molecular biology and LNP delivery; strong written/oral communication.