Olema Oncology
Senior Director, Program Management - Oncology (NDA Lead)
Olema Oncology, Boston, Massachusetts, us, 02298
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr