Senior Director, Program Management – Oncology (NDA Lead)
Join Olema Oncology as Senior Director, Program Management – Oncology (NDA Lead). Lead cross‑functional development and regulatory submission activities for our late‑stage oncology program.
Responsibilities
- Serve as operational lead for a priority oncology program in late‑stage development, overseeing planning, execution, and decision‑making through NDA submission and regulatory review.
- Drive end‑to‑end execution of the NDA, ensuring cross‑functional coordination across Regulatory, Clinical, Biostatistics, CMC, Quality, and Commercial.
- Lead sub‑teams and working groups for modules (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 and dashboards for NDA progress, risks, and mitigation; populate Smartsheet workspace with dashboards for the NDA team and senior leadership.
- Provide clear and concise updates to senior leadership, governance bodies, and external stakeholders; drive scenario planning and strategic decision‑making.
- Ensure commercial and medical affairs have the information, timelines, and coordination needed to support pre‑launch activities.
Ideal Candidate Profile
- Bachelor’s degree in life sciences or related field required; advanced degree (MS, MBA, PharmD, or PhD) preferred.
- Demonstrated experience leading a successful NDA submission or other major regulatory filing as the program management lead.
- Deep understanding of oncology, small‑molecule drug development, with prior experience in a late‑stage oncology program.
- Strong knowledge of regulatory submission requirements and cross‑functional development processes (Clinical, CMC, Regulatory, QA, Biostats, Commercial).
- PMP or equivalent project management certification preferred.
Experience / Required
- Minimum 12 years in biotechnology or pharmaceutical industry, with at least 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 (MS Project, Smartsheet) and collaboration platforms (SharePoint, Teams).
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 ability to adapt to changing priorities and deadlines.
- Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts team success above own interests; supports everyone’s efforts to succeed; shares expertise with others.
Compensation
Base pay range: $270,000 – $285,000 annually. Total compensation also includes equity, bonus, and benefits.
Equal Opportunity
Olema Oncology is an equal opportunity employer. We celebrate diverse backgrounds, expertise, and experiences.
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