Senior Director, Program Management - Oncology; NDA Lead

Senior Director, Program Management – Oncology (NDA Lead)

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP‑3136, is a potent KAT6 inhibitor with best‑in‑class potential.

As the Senior Director of Program Management – Oncology (NDA Lead) reporting to the Vice President of Program Management, you will lead the cross‑functional development and regulatory submission activities for our late‑stage oncology program. This is a high‑impact role that will work closely with the Program Leadership Team and will be 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 role is based out of either our San Francisco or Boston office and will require 10% travel.

• 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.
• Drive the end‑to‑end execution of the NDA, ensuring cross‑functional coordination across Regulatory, Clinical, Biostatistics, CMC, Quality, and Commercial.
• 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.
• Develop and maintain an integrated project plan including regulatory timelines, submission deliverables, and critical path activities; identify and proactively mitigate risks.
• 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 senior leadership; create and maintain detailed timelines in Smartsheet.
• Provide clear and concise updates to senior leadership, governance bodies, and external stakeholders as needed; drive scenario planning and strategic decision making.
• Ensure Commercial and Medical Affairs have the information, timelines, and coordination needed to support pre‑launch activities.

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, MBA, Pharm
  
  D, or PhD) preferred.
• Demonstrated experience leading a successful NDA submission or other major regulatory filing (e.g., BLA, MAA) as the program management lead is an essential requirement.
• A deep understanding of oncology, small‑molecule drug development, with prior experience in a late‑stage oncology program is essential.
• Strong knowledge of regulatory submission requirements and cross‑functional development processes (Clinical, CMC, Regulatory, QA, Biostatistics, Commercial).
• PMP or equivalent project management certification preferred.

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

• Experience supporting Commercial launch planning and cross‑functional readiness efforts.
• Prior involvement in interactions with the FDA, including Advisory Committee preparation or post‑submission communications.

• 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 ability to adapt to changing priorities and deadlines.
• Teamwork and collaboration; balances team and…