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. This 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. The position is based in San Francisco or Boston with travel required.

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 proactively mitigate risks
• Tool Creation, NDA Tracking and Progress Reporting: Create and maintain trackers detailing progress, risks, mitigation, action items, and decisions; maintain Smartsheet Workspace and dashboards for the NDA team and Sr. Leadership
• Executive Reporting: Provide clear updates to senior leadership and external stakeholders; 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: Bachelor’s degree in life sciences or related field required; advanced degree (MS, MBA, PharmD, or PhD) preferred
• Knowledge: Demonstrated experience leading a successful NDA submission or other major regulatory filing (e.g., BLA, MAA) as the program management lead
• Knowledge: Deep understanding of oncology, small molecule drug development, with prior experience in a late-stage oncology program
• Knowledge: Strong knowledge of regulatory submission requirements and cross-functional development processes (Clinical, CMC, Regulatory, QA, Biostats, Commercial)
• Knowledge: PMP or equivalent project management certification preferred

• Experience / Required: A minimum 12 years of experience in the biotechnology or pharmaceutical industry, with a minimum of 8 years in program/project management
• Experience / Required: Exceptional organizational, communication, and leadership skills with a track record of influencing cross-functional teams in a matrixed environment
• Experience / Required: Proficiency with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., SharePoint, Teams)

• Experience / Preferred: Experience supporting Commercial launch planning and cross-functional readiness efforts
• Experience / 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
• Attributes: Ability to distill complex processes/ideas into concise executive summaries for Olema Leadership
• Attributes: Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Attributes: Teamwork and collaboration; balances team and individual responsibilities; shares expertise with others

Education

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

Additional Requirements

• Location: San Francisco or Boston
• Travel: Approximately 10% travel