Senior Director, Program Management - Oncology (NDA Lead)

Role Summary

Senior Director of Program Management – Oncology (NDA Lead) leads cross-functional development and regulatory submission activities for a late-stage oncology program. Serves as the operational lead for the NDA submission process, ensuring alignment across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality standards. Based in San Francisco or Boston, with 10% travel.

Responsibilities

• Program Leadership: Serve as the operational lead for a priority oncology program in late-stage development, overseeing program planning, execution, and decision-making through NDA submission and regulatory review
• NDA Submission Oversight: Drive the end-to-end execution of the NDA, ensuring cross-functional coordination across Regulatory, Clinical, Biostatistics, CMC, Quality, and Commercial
• Cross-functional Integration: Lead sub-teams/working groups for modules (Clinical, Safety, Non-Clinical, Product Label, etc.) to ensure timely data delivery, issue resolution, and effective communication across functions
• Program Planning & Execution: Develop and maintain an integrated project plan including regulatory timelines, submission deliverables, and critical path activities; identify and mitigate risks
• Tool Creation, NDA Tracking and Progress Reporting: Create and maintain trackers and a Smartsheet Workspace with dashboards for the NDA team and Sr. Leadership; maintain timelines in Smartsheet
• Executive Reporting: Provide clear updates to senior leadership and governance bodies; drive scenario planning and strategic decision making
• Commercial Readiness Support: Ensure Commercial and Medical Affairs have the information and coordination needed to support pre-launch activities

Qualifications

• Required: Bachelor’s degree in life sciences or related field; advanced degree (MS, MBA, PharmD, or PhD) preferred
• Required: Demonstrated experience leading a successful NDA submission or other major regulatory filing (e.g., BLA, MAA) as the program management lead
• Required: Deep understanding of oncology, small molecule drug development, with prior experience in a late-stage oncology program
• Required: Strong knowledge of regulatory submission requirements and cross-functional development processes (Clinical, CMC, Regulatory, QA, Biostats, Commercial)
• Preferred: PMP or equivalent project management certification
• Required: Minimum 12 years in biotechnology/pharmaceutical industry with at least 8 years in program/project management
• Required: Exceptional organizational, communication, and leadership skills with a track record of influencing cross-functional teams
• Required: Proficiency with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., SharePoint, Teams)
• Preferred: Experience supporting Commercial launch planning and cross-functional readiness efforts
• Preferred: Prior involvement with the FDA (Advisory Committee preparation or post-submission communications)
• Attributes: Strong communication, cross-functional collaboration, analytical thinking, adaptability, teamwork, and ability to distill complex processes into concise executive summaries

Skills

• Program management and leadership in a matrixed environment
• Regulatory submission planning and execution
• Cross-functional team coordination and communication
• Data tracking, risk management, and governance reporting
• Proficiency with MS Project, Smartsheet, SharePoint, Teams

Education

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, MBA, PharmD, or PhD) preferred