Senior Director, Program Management - Oncology (NDA Lead)

Role Summary

Senior Director of Program Management, Oncology (NDA Lead) will lead the cross-functional development and regulatory submission activities for a late-stage oncology program. The role serves as the operational leader for the NDA submission process, ensuring alignment across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality standards. This position is based in either 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 the sub-teams / working groups for the modules (e.g., 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 proactively mitigate risks
• Tool Creation, NDA Tracking and Progress Reporting: Create and Maintain detailed trackers that detail progress, risks and mitigation as well as action items and decisions. Create and maintain a detailed Smartsheet Workspace that populates dashboards for the NDA team and Sr. Leadership. Create and maintain detailed timelines in Smartsheet
• Executive Reporting: Provide clear and concise updates to senior leadership, governance bodies, and external stakeholders as needed. Drive scenario planning and strategic decision making
• Commercial Readiness Support: Ensure Commercial and Medical Affairs have the information, timelines, and coordination needed to support pre-launch activities

Qualifications

• Knowledge:
  • 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
• Experience / Required:
  • Required: A minimum 12 years of experience in the biotechnology or pharmaceutical industry, with a minimum of 8 years in program/project management
  • Required: Exceptional organizational, communication, and leadership skills with a track record of influencing cross-functional teams in a matrixed environment
  • Required: Proficiency with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., SharePoint, Teams)
• Experience / Preferred:
  • Preferred: Experience supporting Commercial launch planning and cross-functional readiness efforts
  • Preferred: Prior involvement in interactions with the FDA, including Advisory Committee preparation or post-submission communications
• Attributes:
  • Good communication and interpersonal skills; ability to work cross-functionally
  • Ability to distill complex processes / ideas into concise executive summaries for Olema Leadership
  • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; supports everyone’s efforts to succeed

Education

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