Associate Director/Director, Program Management, Pre-Clinical Programs

Responsibilities

• Develop program plans and drive execution: partner with functional leaders and key stakeholders to create the Integrated Development Plan, define critical path activities and program milestones, ensure cross-functional team awareness and readiness to execute on key activities, and drive day-to-day execution of the IDP.
• Deliver on key program milestones: collaborate with functional team leads across clinical operations, clinical development, regulatory, CMC, nonclinical, finance, commercial, medical affairs, and quality assurance, to deliver on program milestones (e.g., regulatory submissions, health authority meetings, clinical trial enrollment targets, data readouts), and ensure continued alignment.
• Manage cross-functional team meetings: work with team members to develop meeting agendas, ensure stakeholder preparedness for meetings, capture and distribute minutes, and ensure follow-through on action items.
• Risk management and scenario planning: proactively identify potential program risks and challenges, work with team members to define relevant mitigation strategies, prepare data-driven scenarios to enable decision making (team level and/or senior level).
• Maintain clear and accurate program dashboards for tracking program goals and key metrics to monitor and assess program performance.
• Support budget processes: Partner with finance team and functional leads to develop and refine program assumptions for budget purposes throughout forecasting cycles.

Qualifications and Experience

• Bachelor’s degree in Life Sciences, Pharmacy or related discipline, advanced degree preferred (e.g., PhD, PharmD, MBA)
• At least 5 years of experience in the biopharma industry in a cross-functional project or program management role with a track record of managing pre-clinical stage programs
• Understanding of the drug development process, including advancing product candidates from IND/CTA submission to late-stage development and ultimately registration with health authorities
• Strong analytical and problem-solving skills with keen attention to detail and an unrelenting drive to deliver results in a fast-paced and dynamic environment
• Ability to thrive in a matrixed, cross-functional team setting while cultivating positive, constructive working relationships across the organization
• Proficiency in using standard project management software (e.g., Smartsheet) and the Microsoft Office suite (i.e., PowerPoint, Word, Excel, SharePoint, etc.)