Olema Oncology
Senior Director, Program Management - Oncology (NDA Lead)
Olema Oncology, Cambridge, Massachusetts, us, 02140
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.
About the Role 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.
Key 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 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.
Ideal Candidate Profile Knowledge
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 (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.
Experience – Required
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 – Preferred
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.
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 the success of the team above own interests; supports everyone's efforts to succeed; shares expertise with others.
The base pay range for this position is expected to be
$270,000 – $285,000
annually; however the base pay offered may vary depending on location, market, job‑related knowledge, skills and capabilities, and experience. The total compensation package also includes equity, bonus, and benefits.
Important Information We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A summary of benefits is available for all applicants.
Fraud Alert Please be aware of job application scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. Olema’s official email addresses end in
@olema.com . Our official corporate website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is
linkedin.com/company/olema-oncology . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in‑person interview.
Please note: Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr
About the Role 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.
Key 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 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.
Ideal Candidate Profile Knowledge
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 (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.
Experience – Required
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 – Preferred
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.
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 the success of the team above own interests; supports everyone's efforts to succeed; shares expertise with others.
The base pay range for this position is expected to be
$270,000 – $285,000
annually; however the base pay offered may vary depending on location, market, job‑related knowledge, skills and capabilities, and experience. The total compensation package also includes equity, bonus, and benefits.
Important Information We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A summary of benefits is available for all applicants.
Fraud Alert Please be aware of job application scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. Olema’s official email addresses end in
@olema.com . Our official corporate website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is
linkedin.com/company/olema-oncology . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in‑person interview.
Please note: Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr