Olema Oncology · 2 weeks ago
Senior Director, Program Management - Oncology (NDA Lead)
Cambridge, MA
Full-time
Onsite
Director/Executive
$270K/yr - $285K/yr
12+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Director of Program Management – Oncology (NDA Lead), you will lead the cross-functional development and regulatory submission activities for late-stage oncology programs, ensuring alignment across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals and regulatory timelines.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
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 Sr. 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
Qualification
Required
Bachelor's degree in life sciences or related field required
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 for this role
A deep understanding of oncology, small molecule drug development, with prior experience in a late-stage oncology program is an essential requirement for this role
Strong knowledge of regulatory submission requirements and cross-functional development processes (Clinical, CMC, Regulatory, QA, Biostats, Commercial)
A minimum 12 years of experience in the biotechnology or pharmaceutical industry, with a minimum of 8 years of experience 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)
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; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
Preferred
advanced degree (MS, MBA, PharmD, or PhD)
PMP or equivalent project management certification
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
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase