Key Responsibilities
Program Management & Execution
- Foster cross-functional alignment and facilitate operational excellence across Clinical Development, Regulatory Affairs, and CMC to ensure timely delivery of program milestones.
- Develop and maintain integrated timelines mapping critical paths, regulatory filings (IND/NDA/BLA), and clinical milestones.
- Drive accountability across stakeholders through effective communication for timely decision-making, risk management, and mitigations.
- Balance strategic thinking with disciplined execution to advance programs through development and regulatory approval.
Governance & Communication
- Implement program management best practices, tools, and governance processes.
- Drive continuous improvement initiatives across development operations.
- Standardize planning methodologies, reporting, and metrics.
- Champion operational discipline across cross-functional teams.
Requirements
- Bachelorβs degree in Biological Sciences, Chemistry, or related field (Ph.D., MS, or MBA preferred).
- 12+ years in biotech/pharma; 7+ years in oncology or hematology drug development (TKIs/hematologic malignancies highly desirable).
- Strongly preferred: experience supporting NDA/BLA/MAA regulatory submissions.
- Preferred: experience in a clinical-stage biotechnology company.
- Minimally 7+ years in dedicated program/project management.
Technical & Soft Skills
- Strong understanding of FDA/EMA regulations, CMC, and clinical trial phases.
- Advanced proficiency in enterprise project management tools (e.g., Smartsheet).
- PMP certification is a strong plus.
- Ability to influence without authority; align teams, resolve conflicts, and drive decisions in a fast-moving biotech environment.
Role Logistics/Compensation
- Full-time remote (40 hours/week); occasional evening/weekend/holiday/on-call work; ~30% travel.
- Benefits included; salary range: $250kβ$295k.
Application Instructions
- Background screen required for employment offers.