Objectives
- Lead the program team for an innovative hepatology program evaluating a first-in-class molecule for a rare disease; current work includes multiple clinical trials including a Phase 3 registrational study.
- Advance the program through regulatory filing, approval, and eventual commercialization.
Responsibilities
- Define asset strategy and lead development and Life Cycle Management projects for assets from discovery to marketplace.
- Set and execute global program strategy, vision, goals, priorities, long-term plans, and schedules; align cross-functional goals to business needs.
- Lead interactions with FDA, other regulatory authorities, and key opinion leaders; proactively identify challenges and develop contingency plans.
- Provide matrix management and strategic/tactical leadership to Global Program Team (GPT) members; ensure deliverables meet scope, objectives, budget, and timelines.
- Accountable for program operating budgets (with the Global Program Manager): lead budget setting, monitor/control expenditures, and manage budget variance.
- Report program progress, issues, critical paths, and risks to TA Unit and executive governance committees.
- Manage multiple assets of increasing complexity.
- Lead fiscal/resource planning: allocate people, information, technologies, time, and capital; manage risks and contingency planning.
- Drive change management by adjusting functional/cross-divisional plans in response to marketplace and strategic direction.
- Lead mentorship and professional development for team members.
- May lead feasibility studies/new opportunities (e.g., in-licensing) and represent the GPL community in internal optimization initiatives.
Required Qualifications
- Advanced scientific degree (MD, PhD, or PharmD).
- Minimum 12 years pharmaceutical industry experience with deep R&D and commercial operations knowledge.
- Minimum 8 years interdisciplinary global experience with complex projects (strategy/execution) and matrix team management.
- Managed global marketing authorization submissions/approvals for multiple NMEs.
Preferred Qualifications
- Broad business/enterprise orientation with proven matrix leadership experience.
- Passion for developing others into future leaders.
Skills/Certifications
- Project Management Professional (PMI) certification desired.
Application instructions
- No phone calls or recruiters please.