Responsibilities:
- Develop program plans and drive execution: partner with functional leaders and key stakeholders to create the Integrated Development Plan (IDP), define critical path activities and program milestones, ensure cross-functional readiness, and drive day-to-day execution.
- Deliver on key program milestones: collaborate with clinical operations, clinical development, regulatory, CMC, nonclinical, finance, commercial, medical affairs, and quality assurance to deliver milestones (e.g., regulatory submissions, health authority meetings, clinical trial enrollment targets, data readouts) and maintain alignment.
- Manage cross-functional team meetings: develop agendas, ensure stakeholder preparedness, capture/distribute minutes, and ensure action-item follow-through.
- Risk management and scenario planning: identify program risks, define mitigation strategies, and prepare data-driven scenarios to support decision-making.
- Monitor and communicate progress: maintain clear program dashboards tracking goals and key metrics.
- Support budget processes: partner with finance and functional leads to develop/refine program assumptions for forecasting.
- Enhance Program Management best practices: collaborate to establish and champion best practices.
Stand Out Skills For Impact:
- Leadership in cross-functional program management; deliver integrated development plans and milestones across clinical, regulatory, CMC, and commercial.
- Translate complex strategy into operational execution with alignment/clarity/accountability in fast-paced matrixed environments.
- Expertise in risk management and scenario planning; implement data-driven mitigation.
- Executive-credible communicator; stakeholder alignment, performance tracking, and decision support via insights/dashboards.
Qualifications And Experience:
- Bachelorβs degree in Life Sciences/Pharmacy or related; advanced degree preferred (PhD, PharmD, MBA).
- 5+ years biopharma cross-functional project/program management experience managing pre-clinical stage programs.
- Understanding of drug development process from IND/CTA through late-stage development and registration.
- Strong analytical/problem-solving skills and attention to detail.
- Ability to thrive in matrixed, cross-functional teams.
- Proficiency with project management software (e.g., Smartsheet) and Microsoft Office (PowerPoint/Word/Excel/SharePoint, etc.).