Olema Pharmaceuticals is a biopharmaceutical company dedicated to developing targeted therapies for women's cancers. With a focus on precision medicine, Olema is committed to advancing innovative treatments that address the unmet medical needs of patients with hormone receptor-positive breast cancer.

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs As the Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs reporting to the Senior Vice President of Regulatory Affairs, your responsibilities will include the following:&nbsp; Lead the development of the New Drug Application (NDA) &nbsp; Lead the development and execution of innovative regulatory strategies supporting Olema products Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)&nbsp; This role is based out of either our&nbsp;Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%.&nbsp; Your work will primarily encompass:&nbsp; Lead the development and submission of the NDA for the company's lead program Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed&nbsp; Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive committee&nbsp; Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices&nbsp; Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)&nbsp; Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives&nbsp; Identify gaps and develop risk mitigation strategies for the regulatory submissions&nbsp; Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements&nbsp; Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams&nbsp; Be flexible to adapt and accommodate additional duties as assigned&nbsp; And will also include:&nbsp; Lead the development of Regulatory Affairs department policies, SOPs, and work instructions&nbsp; Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)&nbsp; Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives and impact on Olema’s programs&nbsp; Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives&nbsp; Mentor and develop other regulatory colleagues in the department&nbsp; Support SVP Regulatory Affairs, as required&nbsp; Ideal Candidate Profile&nbsp; &gt;&gt;&gt; Innovative Experienced Regulatory Strategy Leader&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge Bachelor’s degree in a scientific discipline&nbsp; Advanced degree in scientific discipline Masters, Pharm D or PhD is&nbsp;preferred&nbsp;&nbsp; Experience At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech&nbsp; Minimum of 3 years direct leadership experience Experience with development and execution of regulatory strategies in Oncology Therapeutic area is strongly&nbsp;preferred&nbsp; Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), is a must&nbsp;&nbsp; Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required Ability to work in a fast-paced environment in a hands-on fashion&nbsp; Excellent oral, written, and presentation skills, with experience presenting to the leadership teams Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines Experience in all phases of development and post marketing activities is highly preferred Demonstrated ability to analyze and interpret efficacy and safety data Strong understanding of regulatory operational activities Attributes Self-starter&nbsp; Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities&nbsp; Team Player&nbsp; On site presence at the headquarter is required (minimum 2 days a week) The base pay range for this position is expected to be $275,000-$290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Vice President, Clinical Pharmacology

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.&nbsp;&nbsp; Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.&nbsp; You can view our latest corporate deck and other presentations here.About the role &gt;&gt;&gt;&nbsp; Scientist II - Biology Olema Oncology is currently seeking a talented and innovative&nbsp;Scientist II to join the Research Biology team as a screening specialist. Responsibilities of this position will include developing biology specific strategies for early-stage research projects, development and execution of biochemical and/or cellular phenotypic screening assays of new drug candidates as well as management and mentorship of junior scientists within the team. &nbsp; You will be responsible for conducting experiments to generate high quality data and communicate these results regularly within our project teams. You will work collaboratively within the research team to assist in the conduct of early-stage research, the goal of which is the identification of New Chemical Entities (NCEs). The Senior Scientist in our Research Biology organization will support adherence to all regulatory requirements and company Standard Operating Procedures (SOPs). The final level may be adjusted based on the experience of the candidate. &nbsp; What You Will Do The selected candidate will be responsible for:&nbsp; Design, optimization and execution of primary screening experiments, the goal of which is the identification of additional hits and new chemical scaffolds&nbsp;&nbsp; Provide support for lead optimization by screening compounds and/or supporting structure activity relationship (SAR) studies involving the characterization of the biological activity of compounds in various assays&nbsp;&nbsp; Presentation and communication of results as part of multi-disciplinary team(s)&nbsp; Manage and program automated systems (liquid handlers etc) for medium/high throughput screening assays&nbsp; Assist in the identification/validation of new targets for drug discovery programs&nbsp; Mentor junior team members&nbsp; Work cross-functionally within the Research team, design and communicate Biology strategy and workflows to progress projects from hit to lead onwards&nbsp; Apply relevant scientific principles and techniques to research problems&nbsp; Maintain detailed electronic laboratory notebooks (ELN) and record results in a timely manner&nbsp; Maintain knowledge of state-of-the-art principles and techniques&nbsp; Present findings internally and externally and contribute to the publication of the work of the project team&nbsp; May contribute to the development of patent applications as appropriate&nbsp; Comply with all safety requirements&nbsp; General lab duties as assigned&nbsp; Ideal Candidate Profile &gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. &nbsp; Knowledge PhD. in Cancer Biology, Pharmacology, Biochemistry, or a related field&nbsp; 3+ years of relevant industry experience, preferably in small molecule drug discovery&nbsp; &nbsp;Experience Prior experience with in vitro assay development, execution, and optimization for drug screening, ideally within a drug discovery setting&nbsp; Experience in designing and delivering biology strategies for research projects&nbsp; Excellent and proven project management skills&nbsp; Complete understanding and wide application of technical principles, theories, concepts and techniques&nbsp; Knowledge of and ability to use standard molecular and cell biology techniques are required, for example, Western blotting, microscopy, plate-based assays and qRT-PCR&nbsp; Asceptic mammalian cell culture experienced is required&nbsp; Knowledge of breast cancer and/or cancer signaling pathways preferred&nbsp; Knowledge of scientific principles and concepts, and current on relevant scientific literature&nbsp; Good general knowledge of other related disciplines&nbsp; Ability to read, analyze and interpret common scientific and technical journals&nbsp; Strong publication track record in oncology, biochemistry and/or drug discovery&nbsp; Experience working with high throughput screening with robotic liquid-handling automation tools is required&nbsp; Experience with assay miniaturization and optimization preferred&nbsp; Proficiency with Microsoft Office. Proficiency with GraphPad Prism, or other analytical software&nbsp; Experience working with Dotmatics or similar database/ELN software is preferred&nbsp; Data Science/Informatics skills and experience is preferred&nbsp; &nbsp;Attributes Excellent verbal and written communication and skills&nbsp; Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines&nbsp; Effective planning, organization and time management skills including the ability to support and prioritize multiple projects&nbsp; A commitment to excellence&nbsp; A self-motivated, flexible and enthusiastic team player who is excited about advancing new medicines and delivering impactful drugs&nbsp; 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&nbsp; Entrepreneurial mindset and the ability to prioritize key work-streams and requirements that will change over the near and mid-term&nbsp; A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required&nbsp; Be a “difference maker” in terms of one’s professionalism and contributions&nbsp; Have impeccable professional ethics, integrity and judgment&nbsp; Be collegial, hard-working, confident, a self-starter and have a passion for results&nbsp; The base pay range for this position is expected to be $150,000 - $165,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Scientist II - Biology

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.&nbsp;&nbsp; Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.&nbsp; You can view our latest corporate deck and other presentations here.About the Role &gt;&gt;&gt; Senior IT Systems Administrator&nbsp; As the Senior IT Systems Administrator reporting to the Senior Director, IT Infrastructure and Operations, you will manage, maintain, and optimize the core infrastructure, applications, and services that Olema relies on to securely and efficiently scale our business. This role encompasses system administration, operational support, and hands-on work with both on-prem and cloud-based infrastructure. The Senior IT Systems Administrator will also contribute to security, compliance, and automation initiatives, while mentoring junior staff and serving as a subject matter expert (SME) for critical IT systems.&nbsp; This role is based out of our San Francisco office.&nbsp; Your work will primarily encompass:&nbsp; Provide daily support for enterprise solutions, including troubleshooting, maintenance, and performance monitoring&nbsp; Manage cloud system across multiple cloud platform environments&nbsp; Perform maintenance and problem solving with respect to on-premises and cloud-based infrastructure&nbsp; Complete scheduled maintenance and system hardening activities aligned with security requirements&nbsp; Manage backup operations, disaster recovery planning, and periodic Disaster Recovery testing&nbsp; Lead small-to-medium IT projects from planning through execution, including requirements gathering, stakeholder communication, and delivery of technical solutions&nbsp; Collaborate with project teams to implement IT initiatives and deploy new technology solutions&nbsp; Maintain and update system documentation, including configuration, changes, and technical procedures&nbsp; &nbsp; Maintain accuracy of the Configuration Management Database (CMDB) for enterprise systems&nbsp; Coordinate with MSP service teams on patching and vulnerability remediation efforts to strengthen the overall security posture&nbsp; Participate in periodic system access reviews, compliance audits, and other IT governance activities&nbsp; Act as a subject matter expert (SME) and escalation point for incident resolution&nbsp; Coordinate with the Help Desk to analyze application issue trends and drive permanent fixes&nbsp; Enable knowledge sharing by documenting processes and providing guidance to IT team members&nbsp; Mentor junior staff to develop technical skills and strengthen the IT team&nbsp; Identify opportunities for automation, streamline IT processes, and eliminate manual work to enhance efficiency&nbsp; Communicate clearly with diverse stakeholders (executives, scientists, staff) and tailor explanations of technical issues to the appropriate audience&nbsp; Ideal Candidate Profile &gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; Bachelor's degree in computer science or related required&nbsp; Certifications in Information Security and IT disciplines such as OKTA (Admin &amp; workflow, Certification OCA), MCSE, Netskope (Certification NCCSA), CISSP, CEH, Network+, etc.&nbsp; Technical expertise in Okta and Microsoft 365 administration, MDM (JAMF &amp; Intune), SAML integrations, SaaS management, Networking (Meraki), Zoom, Python scripting, Mac/PC, GCP, AWS, Office 365, Arctic Wolf, Netskope and CrowdStrike&nbsp; Comprehensive knowledge and hands-on experience in implementing, managing, and securing networks (DHCP, DNS, SSID, LAN, WAN) with strong problem-solving skills&nbsp; Experience in&nbsp;supporting Mac, PC, and Chrome hardware, as well as mobile devices (iPhone, iPad, and Android)&nbsp; Proven experience managing IT projects, balancing competing deadlines, and delivering results in a fast-paced environment &nbsp; Experience:&nbsp; Minimum 7+ years of hands-on IT systems administration experience&nbsp; Experience working in a fast-growing biotechnology company and supporting users in life sciences or biopharma environment is required&nbsp; Direct experience with SaaS products, solutions, or ecosystems required&nbsp; Driving results and outcomes while solving complex problems&nbsp; Hands-on, resolving daily tickets and projects as needed&nbsp; Detail-oriented and customer-focused, with a strong ability to deliver results aligned with data and business needs&nbsp; &nbsp;Attributes:&nbsp; Strong communication and interpersonal skills with the ability to adapt technical explanations for different audiences&nbsp; Demonstrated ability to build trust, foster collaboration, and drive adoption of IT solutions across both technical teams and business stakeholders Demonstrated excellent written and oral communication skills, as well as thoughtful listening skills, to facilitate interaction with all levels of an organization&nbsp; Ability to analyze complex business problems and evaluate solutions&nbsp; Superior organization, planning, and project management skills The base pay range for this position is expected to be&nbsp;$150,000 - $170,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MT1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Senior IT Systems Administrator

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Clinical Science&nbsp; As the Associate Director, Clinical Science reporting to the Director, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will collaborate within a multi-disciplinary team—including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management—to plan, conduct, and analyze clinical trials. Your job contributes to and supports Olema’s mission of developing therapies that offer the potential to improve outcomes for women living with cancer.&nbsp; This role may be based out of our San Francisco, CA or Cambridge, MA office and will require up to 15% travel.&nbsp; Your work will primarily encompass:&nbsp; Assisting in writing clinical documents including protocols, amendments, investigator’s brochures, clinical study report (CSR), and the clinical sections of regulatory documents&nbsp; Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopsis and protocols&nbsp; Participating in ongoing clinical data review in collaboration with a cross functional team&nbsp; Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety&nbsp; Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings&nbsp; And will also include:&nbsp; Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions&nbsp; Collaborating with Clinical Operations and other team members to develop agendas, training materials and presentations for site visits, investigator meetings and other study related activities&nbsp; Ensuring adherence to Olema’s Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example&nbsp; Maintaining clinical and technical expertise in the therapeutic area of oncology&nbsp; Attending scientific meetings pertinent to clinical science activities&nbsp; Ideal Candidate Profile &gt;&gt;&gt; Self-Motivated Clinical Scientist&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered&nbsp; Experience in oncology clinical development is required&nbsp; Ability to interact effectively within a cross-functional team&nbsp; Experience:&nbsp; 5-7+ years’ experience working as a clinical scientist in the biotech/pharmaceutical industry&nbsp; Comprehensive knowledge of oncology clinical trial implementation and drug development process&nbsp; Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones&nbsp; Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus&nbsp; Ability to proactively identify challenges/problems and propose solutions with a strong sense of urgency Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork&nbsp; Attributes:&nbsp; Strong attention to detail&nbsp; Excellent written and oral communication skills&nbsp; Ability to work in a diverse and dynamic cross-functional team&nbsp; Passionate about the drug-development process&nbsp; Self-starter who thrives in a fast-paced environment&nbsp; The base pay range for this position is expected to be $200,000 - $215,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, Clinical Science

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Clinical Science&nbsp; As the Associate Director, Clinical Science reporting to the Director, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will collaborate within a multi-disciplinary team—including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management—to plan, conduct, and analyze clinical trials.&nbsp; Your job contributes to and supports Olema’s mission of developing therapies that offer the potential to improve outcomes for women living with cancer.&nbsp; This role may be based out of our San Francisco, CA or Cambridge, MA office and will require up to 15% travel.&nbsp; Your work will primarily encompass:&nbsp; Assisting in writing clinical documents including protocols, amendments, investigator’s brochures, clinical study report (CSR), and the clinical sections of regulatory documents&nbsp; Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopsis and protocols&nbsp; Participating in ongoing clinical data review in collaboration with a cross functional team&nbsp; Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety&nbsp; Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings&nbsp; And will also include:&nbsp; Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions&nbsp; Collaborating with Clinical Operations and other team members to develop agendas, training materials and presentations for site visits, investigator meetings and other study related activities&nbsp; Ensuring adherence to Olema’s Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example&nbsp; Maintaining clinical and technical expertise in the therapeutic area of oncology&nbsp; Attending scientific meetings pertinent to clinical science activities&nbsp; Ideal Candidate Profile &gt;&gt;&gt; Self-Motivated Clinical Scientist&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered&nbsp; Experience in oncology clinical development is required&nbsp; Ability to interact effectively within a cross-functional team&nbsp; Experience:&nbsp; 5-7+ years’ experience working as a clinical scientist in the biotech/pharmaceutical industry&nbsp; Comprehensive knowledge of oncology clinical trial implementation and drug development process&nbsp; Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones&nbsp; Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus&nbsp; Ability to proactively identify challenges/problems and propose solutions with a strong sense of urgency Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork&nbsp; Attributes:&nbsp; Strong attention to detail&nbsp; Excellent written and oral communication skills&nbsp; Ability to work in a diverse and dynamic cross-functional team&nbsp; Passionate about the drug-development process&nbsp; Self-starter who thrives in a fast-paced environment&nbsp; The base pay range for this position is expected to be $200,000 - $215,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, CMC Drug Substance Development and Manufacturing&nbsp; As the Associate Director, CMC Drug Substance Development and Manufacturing reporting to the Senior Director of CMC Drug Substance you will support drug substance process development and cGMP manufacturing activities at external contract manufacturing and development organizations (CDMOs). We are looking for an experienced process chemist with a track record of successful oversight of manufacturing small molecule drug substances under cGMP. In addition to supporting process development activities and managing manufacturing campaigns, including reviews of master and executed batch records, this individual will contribute to the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc.&nbsp; This role is based out of our San Francisco or Boston office and will require up to 10% travel.&nbsp; &nbsp;Your work will primarily encompass:&nbsp; Provide technical guidance and lead drug substance process development, manufacturing and CDMO management &nbsp; Lead technical meetings with CDMOs and provide status updates to internal teams&nbsp; Represent drug substance function on cross-functional CMC and project teams, providing technical and strategic input&nbsp; Review manufacturing documentation to enable GMP drug substance production and clinical supply&nbsp; Collaborate with QA/QC to identify and evaluate deviations, CAPAs and change controls&nbsp; Collaborate with SMEs in the CMC department on the development and validation of analytical test methods for drug substances at CDMOs&nbsp; Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications&nbsp; Stay current with emerging technologies, regulatory trends, and industry best practices in drug substance development&nbsp; Ideal Candidate Profile&nbsp;&gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge and Experience:&nbsp; M.Sc. or Ph.D. in Organic Chemistry, or related discipline with 8+ years of experience in a CMC development organization&nbsp; Expertise in small molecule process development and GMP manufacturing, preferably across all phases of development (pre-IND to commercial manufacturing)&nbsp; Knowledge of good manufacturing practices for the preparation of drug substance for clinical studies&nbsp; Knowledge of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance&nbsp; Demonstrated successful leadership in a pharmaceutical CMC drug substance development role&nbsp; Experience authoring and reviewing technical documents including, but not limited to development reports, master batch records, analytical testing methods, and specifications&nbsp; Effective written, oral communication and interpersonal skills&nbsp; Power-user of Microsoft Office Suite, Chemdraw, Scifinder, etc.&nbsp; Attributes:&nbsp; A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job Highly analytical and detail oriented&nbsp; Strong data and document organization skills&nbsp;&nbsp; Self-starter&nbsp; Goal and data driven&nbsp; Ability to multi-task and shift priorities rapidly to meet tight deadlines&nbsp; Aspires to the highest of scientific and ethical standards&nbsp; Keen to improve processes and overcome inefficiencies&nbsp; The base pay range for this position is expected to be&nbsp;$175,000 - $185,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MT1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, CMC Drug Substance Development and Manufacturing

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Global Regulatory Strategy - International&nbsp; As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions. &nbsp; This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15% Your Work Will Primarily Encompass:&nbsp; With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency Assist in risk assessment and mitigation planning for regulatory deliverables Ideal Candidate Profile&nbsp;&nbsp; We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy Knowledge:&nbsp; Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred Experience:&nbsp; 7+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence&nbsp; Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines) Oncology therapeutic area experience required Experience collaborating in cross-functional, matrixed teams&nbsp; Experience working withCROs and other partners Attributes:&nbsp; Strong organizational, project management, and problem-solving skills Excellent oral, written, and presentation skills Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities Self-starter with the ability to work both independently and within teams The base pay range for this position is expected to be&nbsp;$176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, Global Regulatory Strategy - International

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Global Regulatory Strategy - International&nbsp; As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions. &nbsp; This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15% Your Work Will Primarily Encompass:&nbsp; With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency Assist in risk assessment and mitigation planning for regulatory deliverables Ideal Candidate Profile&nbsp;&nbsp; We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy Knowledge:&nbsp; Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred Experience:&nbsp; 7+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence&nbsp; Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines) Oncology therapeutic area experience required Experience collaborating in cross-functional, matrixed teams&nbsp; Experience working with CROs and other partners Attributes:&nbsp; Strong organizational, project management, and problem-solving skills Excellent oral, written, and presentation skills Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities Self-starter with the ability to work both independently and within teams The base pay range for this position is expected to be&nbsp;$176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Quality Systems&nbsp; &nbsp; As the Associate Director of Quality Systems, reporting to the Director of Quality Systems, you will support the implementation, business requirements, and maintenance of the Veeva Quality suite of Computerized Systems and potentially AI initiatives. You will also develop, maintain and deliver training materials on such systems. You will collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to generate metrics and KPIs in order to facilitate continuous improvement and quality management review. &nbsp; This role may be based out of our San Francisco, CA or Cambridge, MA office and will require 20% travel.&nbsp; Your work will primarily encompass:&nbsp; Managing and upgrading the electronic quality management processes (eQMS) including modules for: document control, company training management, internal and external audits, vendor management, change control and deviation/CAPA management. Responsibility may additionally extend to Regulatory Information Management Systems (RIMS) and Inspection Management Systems to support Phase 3 clinical programs and transition to commercial manufacturing&nbsp; Serve as a Subject Matter Expert in Veeva Systems and Veeva Administrator to support business needs Liaising between QA, Operations (Regulatory, CMC, Non-Clinical, Drug Safety, Clinical) and IT to define, implement and manage eQMS systems; interactions for the training management will also include People &amp; Culture, Facilities, Legal, and Finance&nbsp; Collaborating with IT and Operations for QMS process/system enhancements and process improvements&nbsp; Authoring, reviewing and, at times, approving policies, procedures, and other related documents for the Quality Management Systems processes at Olema&nbsp; Escalating Quality Management Systems-related issues to management for timely mitigation and resolution&nbsp; Supporting evolution of training materials and employee training execution for Quality Management Systems&nbsp; Supplying Quality Management System support during regulatory inspections with document retrieval functions, inspection logistics oversight and other support as needed&nbsp; Maintaining and managing audit (external and internal) documentation, while acting as a subject matter expert for electronic Quality Management Systems&nbsp; Creating and delivering QMS key performance and quality matrices to QA leadership and Executive management&nbsp; Communicating and promoting a culture of quality and operational excellence at Olema&nbsp; Ideal Candidate Profile &gt;&gt;&gt;&nbsp;&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; Bachelor’s degree in a scientific field is required, Master’s degree is preferred Strong understanding of QMS, both methodologies and standards Strong understanding of FDA, EMA, and other ICH Health Authority requirements Understanding of industry quality management tools, quality systems (e.g. Veeva strongly preferred) Knowledge of quality principles and QA methodologies including GAMP5, 21 CFR Part 820, EudraLex Volume 4, ICH Chapters 7 through 11 and ISO 9001 Experience:&nbsp; 8+ years relevant work experience in the pharmaceutical/biotech industry Experience with design and implementation of QMS business process and life cycle management Experience in supporting FDA inspections as a QMS subject matter expert and an ability to interpret regulatory requirements Experience in validation and configuration of systems to support business needs Experience authoring policies, procedures, and other technical documents for the Quality Management Systems processes Technical experience with data mining tools such as Power BI Attributes:&nbsp; Demonstrated ability to work in a changing, cross-functional environment Detail oriented but also risk based Ability to handle diverse workloads, and capable of completing tasks with little or no supervision Strong communication skills and the ability to effectively collaborate with key stakeholders Strong project management and time management skills The base pay range for this position is expected to be $190,000 - $200,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, Quality Systems

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Safety Operations&nbsp; As the Associate Director of Safety Operations reporting to the Director of Safety Operations, you will routinely solve complex project management issues while assisting with the oversight of the daily operations of the Olema Safety team as well as manage safety reporting compliance.&nbsp; &nbsp; This role may be based out of our San Francisco, CA or Boston, MA office and will require 5% travel.&nbsp; Your work will primarily encompass:&nbsp; Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners as applicable, within regulatory and business partner’s timelines and according to departmental standard operating procedures (SOPs)&nbsp; Managing safety reporting compliance&nbsp; &nbsp; Drafting and reviewing pharmacovigilance documents&nbsp;&nbsp; Preparing metrics, particularly related to safety reporting, and reporting to upper management as needed &nbsp; Collaborating with cross functional teams, Clinical Operations, Data Management and Biostatistics; participating in meetings and teleconferences with cross-functional teams, CROs, and business partners&nbsp; Responsible for managing vendors, audit and inspection readiness and implementation, pre-launch activities, pre-commercial and commercial launch, manage NDA safety operations&nbsp; Assisting with study start up and management of new/future studies&nbsp; &nbsp; Spearheading the development of departmental systems including SOPs and departmental guidelines&nbsp; &nbsp; Performing SAE Reconciliation&nbsp; &nbsp; Training internal and external groups in Pharmacovigilance principles and best practices&nbsp; &nbsp; Working with safety vendor for daily operations tasks and implementing key action items&nbsp; Ideal Candidate Profile &gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge BA/BS degree in life sciences, pharmacy, nursing, or related degree&nbsp;&nbsp; Previous experience with drug safety databases&nbsp;&nbsp;&nbsp; Experience 7-10 years of pharmaceutical industry experience, of which 5 years have been safety experience&nbsp;&nbsp; Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency&nbsp; Excellent understanding of good pharmacovigilance practices and current global (e.g., EU, US and Canada) pharmacovigilance regulations, clinical trial methodology, and Good Clinical Practices (GCP)&nbsp; Well-developed presentation, communication and interpersonal skills, and strong oral and written communication skills&nbsp; Must have experience managing external vendors as well as audit and inspection readiness, pre-commercial, commercial launch readiness&nbsp; Strong organizational, project management, technical and problem-solving skills&nbsp; Attributes Ability to work independently, demonstrating initiative and flexibility&nbsp;&nbsp; Continuously seek opportunities to improve processes and systems related to drug safety&nbsp;&nbsp; Maintain confidentiality and adhere to ethical standards in all aspects of the job&nbsp; Strong verbal and written skills and demonstrated cross collaboration skills&nbsp; The base pay range for this position is expected to be $195,00 - $210,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-MT1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, Safety Operations

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Safety Sciences&nbsp; As the Associate Director, Safety Sciences reporting to the Senior Director of Safety Sciences, you will serve as a safety science expert to support the development of Olema’s products. You will work effectively with cross-functional teams across the organization as well as with external stakeholders, such as business partners and safety vendors/contractors. &nbsp; This role is based out of our San Francisco or Boston office and will require less than 10% travel&nbsp; Your work will primarily encompass:&nbsp; Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment &nbsp; Perform signal evaluation for identified safety signal and author safety evaluation reports&nbsp; Manage preparation and completion of safety documents, including [DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc.] &nbsp; Participate/lead responses to regulatory inquiries and other risk management activities&nbsp; Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), as required, including reviewing source documents, reviewing case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessment, and assisting Safety Operations staff in determining reportability &nbsp; Conduct literature search activities and develops key strings for search criteria and review information &nbsp; Support and attend Data Monitoring Committee (DMC) meetings, as required &nbsp; Support quality systems, inspection readiness, audit, and inspections &nbsp; Actively participate in process improvement initiatives, e.g. the development and maintenance of relevant SOPs&nbsp; Work effectively with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors&nbsp; Apply effective communication skills to lead and facilitate safety team meetings &nbsp; Apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities&nbsp; Ideal Candidate Profile &gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; MD, PhD in the field of medical/biological science, PharmD, or RN degree&nbsp; Small Molecule and Oncology is a must&nbsp; Experience:&nbsp; 5+ (MD, PhD, PharmD) or 8+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry&nbsp; Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents&nbsp; Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities&nbsp; Experience working with business partners and managing safety vendors&nbsp; Ability to work with the safety database for purposes of clinical/medical case review and simple queries&nbsp; Familiar with the clinical database/EDC&nbsp; Experience mentoring and teaching new/junior team members&nbsp; Attributes:&nbsp; Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines&nbsp; Strong verbal and written skills to convey safety findings and recommendations with clarity&nbsp; Excellent analytical, problem-solving, strategic planning, and interpersonal skills&nbsp; Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization&nbsp; Demonstrates sound judgment, professionalism, and strong ethical standards&nbsp; The base pay range for this position is expected to be $195,000 - $210,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-MT1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Associate Director, Safety Sciences

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Associate Director, Safety Sciences As the Associate Director, Safety Sciences reporting to the Senior Director of Safety Sciences, you will serve as a safety science expert to support the development of Olema’s products. You will work effectively with cross-functional teams across the organization as well as with external stakeholders, such as business partners and safety vendors/contractors. &nbsp; This role is based out of our San Francisco or Boston office and will require less than 10% travel&nbsp; Your work will primarily encompass:&nbsp; Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment &nbsp; Perform signal evaluation for identified safety signal and author safety evaluation reports&nbsp; Manage preparation and completion of safety documents, including [DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc.] &nbsp; Participate/lead responses to regulatory inquiries and other risk management activities&nbsp; Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), as required, including reviewing source documents, reviewing case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessment, and assisting Safety Operations staff in determining reportability &nbsp; Conduct literature search activities and develops key strings for search criteria and review information &nbsp; Support and attend Data Monitoring Committee (DMC) meetings, as required &nbsp; Support quality systems, inspection readiness, audit, and inspections &nbsp; Actively participate in process improvement initiatives, e.g. the development and maintenance of relevant SOPs&nbsp; Work effectively with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors&nbsp; Apply effective communication skills to lead and facilitate safety team meetings &nbsp; Apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities&nbsp; Ideal Candidate Profile &gt;&gt;&gt; &nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; MD, PhD in the field of medical/biological science, PharmD, or RN degree&nbsp; Small Molecule and Oncology is a must&nbsp; Experience:&nbsp; 5+ (MD, PhD, PharmD) or 8+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry&nbsp; Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents&nbsp; Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities&nbsp; Experience working with business partners and managing safety vendors&nbsp; Ability to work with the safety database for purposes of clinical/medical case review and simple queries&nbsp; Familiar with the clinical database/EDC&nbsp; Experience mentoring and teaching new/junior team members&nbsp; Attributes:&nbsp; Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines&nbsp; Strong verbal and written skills to convey safety findings and recommendations with clarity&nbsp; Excellent analytical, problem-solving, strategic planning, and interpersonal skills&nbsp; Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization&nbsp; Demonstrates sound judgment, professionalism, and strong ethical standards&nbsp; The base pay range for this position is expected to be $195,000 - $210,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-MT1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Corporate Counsel We are seeking a Corporate Counsel, reporting to our Vice President, Corporate Law. You will be an integral member of the Legal Department and will have an opportunity to operate independently in a dynamic environment to support the evolving corporate needs at Olema. You will manage the Company’s securities law filings, have responsibility for certain corporate governance matters, and will collaborate with the Vice President, Corporate Law to engage with the Company’s executive leadership team and Board of Directors.&nbsp; You will also assist in providing practical legal advice on a broad range of corporate, transactional, and securities law topics, as well as the organization’s day-to-day operational needs and strategic priorities. This is a fantastic opportunity to join a fast-paced and growing company at an integral time. This role is based out of our Cambridge, Massachusetts office. Your work will primarily encompass:&nbsp; Manage the drafting, reviewing and coordinating of the Company’s securities law filings, including 10-Ks, 10-Qs, 8-Ks, Proxy, Section 16 reports, annual stockholder meeting, and related compliance, working closely with the finance team and with outside counsel Responsible for maintenance of corporate governance documents, including corporate policies and committee charters Work with the Human Resources and Finance teams on various stock-based compensation and equity compensation plan matters, including assisting with administration of the Company’s equity compensation platform Assist in managing the board platform and supporting board preparatory work streams Assist and support Vice President, Corporate Law with drafting and reviewing of board and committee consents, minutes, and other actions Manage international subsidiary, records, and related governance workstreams Assist and support Vice President, Corporate Law with respect to corporate transactions, including collaboration agreements, licensing agreements, and capital markets transactions. This includes, but is not limited to, managing the Company’s data room, preparing disclosure schedules and other deliverables and reviewing the definitive documentation Review, interpret and analyze existing contracts from time to time, and prepare correspondence to third parties as requested Conduct legal research and analysis on complex legal issues and stay abreast of relevant legal developments Support various legal workstreams related to, and collaborate cross-functionally to prepare for, potential commercial launch Provide legal advice and guidance and complete special projects, on an as-needed basis, covering various matters, including HR, IT, facilities, real estate, tax, etc Ideal Candidate Profile &gt;&gt;&gt; Biotech Corporate Attorney with SEC Filing Experience A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge J.D. from a top national law school with exceptional academic credentials required Must be admitted, active and in good standing with the Massachusetts state bar or with another state bar and registered, or eligible to register, as in-house counsel with the Commonwealth of Massachusetts Broad and deep expertise in corporate and U.S. securities laws, corporate governance, disclosure practices, and board governance matters, including best practices Familiarity with public company accounting, tax and finance processes, terminology, systems and issues, including a basic knowledge of financial statements, GAAP accounting, and tax matters Experience 3-5 years of relevant experience, including working at a leading national law firm as a general corporate, securities, or corporate governance attorney, ideally in the life sciences industry, and/or significant time spent in-house, ideally at a leading public biotech, pharmaceutical or life sciences company. Law firm candidates with appropriate experience are strongly encouraged to apply Strong experience with coordination and timely and continuous filing of disclosure documentation with the SEC Attributes Exceptional verbal and written communication skills Strong attention to detail Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines; the desire to learn and grow Entrepreneurial mindset: the ability to own and prioritize key workstreams and requirements that will change over the near and mid-term; ability to change course as required in a fast-paced organization; sense of ownership and ability to manage multiple parallel workstreams Ability to balance team and individual responsibilities; “can do” attitude and problem solver; ability to operate autonomously while being a collaborative team player and partner with other members of the Legal team and internal clients Self-motivated and enthusiastic; sense of humor a plus Have impeccable professional ethics, integrity, and judgment The base pay range for this position is expected to be&nbsp;$210,000 - $230,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-MK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Corporate Counsel

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Director, Regulatory Labeling&nbsp; As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will&nbsp;lead the&nbsp;development&nbsp;of labeling&nbsp;for clinical supplies&nbsp;as well as development of commercial labeling materials&nbsp;for&nbsp;Olema products.&nbsp;This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation.&nbsp;This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.&nbsp; This role is based out of our Cambridge or San Francisco office and will require 10% travel.&nbsp; Your work will&nbsp;primarily&nbsp;encompass:&nbsp;&nbsp; Oversee the prioritization, development, revision and approval of clinical supply labeling (e.g., active, placebos and standard of care drugs) in various countries to support Olema’s clinical pipeline&nbsp; Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams Develop and implement harmonized labeling processes for developing new product labels and associated life-cycle activities&nbsp; Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling generation and maintenance&nbsp; Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites Oversight and accountability for labeling activities managed by external vendors, ensuring coordination and timely delivery Develop and maintain labeling documents including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents to support initial Marketing Authorization and updates for new indications, efficacy data, product quality changes and safety related information topics Present to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed labeling text Supports responses to Health Authority queries related to labeling Create and maintain artwork for critical Regulatory functions: prepare labeling mock-ups for Health Authority submissions, manage expedited artwork approval process for US and ex-US market product launches Design, implement and maintain document tracking, history, versioning for labeling documents&nbsp; Represent Regulatory Affairs Labeling in project teams across products and ensure standard implementation of regulations across development products A love of challenging, important work.&nbsp;We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of&nbsp;knowledge,&nbsp;experience, and&nbsp;attributes&nbsp;for this role.&nbsp; Knowledge:&nbsp; Bachelor’s degree is required; bachelor's degree or master's degree in a scientific field is preferred &nbsp; Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance&nbsp; Knowledge of applicable regulations and standards affecting labeling packaging of investigational drugs globally&nbsp; Clinical Supply Packaging and/or Labelling and/or Distribution with external vendors (e.g. technical, process, plan or system) Strong knowledge of FDA and EMA product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required) Strong collaboration, presentation, communication, interpersonal, and leadership skills Experience:&nbsp; 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical Proven 3-5 years in a leadership role Experience in regulatory affairs and quality assurance and deep knowledge of global regulatory labeling development and maintenance Experience working with ICH Health Authorities Experience with developing and managing labeling content for for major submissions (e.g., NDA/BLA), through negotiations and approval preferred Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status Ability to interact successfully in a diverse global environment and with senior level management to effectively influence and manage change Proven general understanding of clinical study designs and Global Manufacturing Practices (GMP) documentation. AD-Promo experience is preferred Oncology product label development is required Attributes:&nbsp; Strong communication skills and the ability to effectively build productive internal and external working relationships Strong organizational, project management, and time management skills Ability to independently execute day-to-day responsibilities Ability to independently exercise judgement in developing methods, techniques, and evaluation criteria for obtaining results in a fast-paced environment consisting of internal and external team members Excellent attention to detail, strong critical thinking, problem solving, and adept at managing change The base pay range for this position is expected to be $230,000 - $245,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-MK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Director, Regulatory Affairs - Labeling

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Senior Director of Clinical Business Operations&nbsp; As the Senior Director of Clinical Business Operations, reporting to the SVP of Clinical Operations, your work will primarily support the Clinical Department’s initiatives to contribute to the success of our clinical trials. Your deep experience in vendor management and contracting will develop our global clinical outsourcing strategy. &nbsp;This role is a key partner to the clinical study teams, organizing the selection of service providers, coordinating requests for proposal and bid defenses, and negotiating work orders/change orders.&nbsp; This role is based out of either our office San Francisco or Cambridge office and requires approximately 10-15% travel.&nbsp; Your work will primarily encompass:&nbsp; Oversee communication with clinical vendors regarding contracts, scope of work, and budgets Lead the Request for Proposal (RFP) and vendor bidding process for clinical trials, including writing of RFP, bid comparison analysis, manage bid defense meetings, and vendor scorecard development Manage the identification of service providers for clinical studies in collaboration with the study management teams and clinical departments Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department and negotiate terms of contract as needed Work with clinical department partners to build the Scope of Work (SOW) for the contract including negotiation of costs Review all change notification forms (CNFs) and Change Orders (COs) with contract manager and finance to ensure that correct pricing is established Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department Establish strong partnerships with the clinical vendors to understand contracting challenges and develop simplified and collaborative resolutions to these challenges Drive the Fair Market Value (FMV) process through working with the study teams and vendors to analyze and negotiate the final work order and subsequent change orders Establish and manage the vendor governance process with key clinical vendors. &nbsp;Document key decisions and action plans and ensure compliance with the decisions established in governance meetings Work with study teams to establish KPI process and help establish standard clinical vendor Key Performance Indicators (KPIs) to enhance vendor oversight and performance Collaborate with legal and clinical operations teams to establish template clinical site contracts/clinical trial agreements (CTAs) Interact with finance and clinical operations teams to build template site budget utilizing a FMV tool. &nbsp;In some studies, may help negotiate these budgets with clinical sites Attend Study Execution Team (SET), monthly budget, and clinical meetings. &nbsp;This person may be asked to present at these meetings as needed Provide insight and feedback at Clinical Operations Leadership Team Lead in clinical outsourcing process/tool development, improvement, and implementation Ideal Candidate Profile &gt;&gt;&gt;&nbsp;&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge:&nbsp; BS or MS in a relevant discipline is required Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions Legal, financial, clinical operations, and regulatory acumen&nbsp; Strong skills in the following: writing, critical analysis/evaluation, benchmarking, contracting, and negotiating Strategic and integrative thinker to establish norms for Outsourcing across the Clinical Department Knowledgeable of ongoing and new development clinical programs Excellent knowledge of the costs of clinical procedures, and how to process the data for estimating of clinical programs Strong skills in computer systems and software to manage contracting, finance, and invoice processing Experience:&nbsp; 15+ years of experience working in clinical research, biotech, and/or pharmaceutical company Experience managing clinical outsourcing or procurement professionals Expertise in building RFPs and leading the vendor selection process&nbsp;&nbsp; Strong experience in vendor and site CTA contracting/budgeting, FMV assessment, Scientific Collaborator engagement to conduct clinical trials Experience in providing thought leadership and consistent customer service Expertise in the clinical contracting process, including but not limited to the following: Confidentiality Disclosure Agreements (CDAs), Scope of Work (SOW), FMV assessment, contract negotiations and management, Work Orders, Change Orders, and the Budget process Demonstrated leadership skills while working in a fast paced and changing environment Attributes:&nbsp; Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific, legal, financial, and operational perspectives Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks Excellent skills in negotiation/influence, management, grant/contract administration, written, and oral communications The base pay range for this position is expected to be $225,000 - $265,000&nbsp;annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Senior Director, Clinical Business Operations

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.About the Role &gt;&gt;&gt; Senior Manager, Clinical Supply Chain &nbsp; The Senior Manager, Clinical Supply Chain will play a critical supporting role in the execution and coordination of clinical supply activities across global development programs. This individual will work closely with Clinical Supplies leadership to manage operational tasks spanning production planning, labeling, inventory reporting, and cross-functional logistics support.&nbsp; This role will ensure that our investigational products are available and compliant across our clinical programs. They will collaborate with experienced team members and external partners while building strong foundational expertise. This provides a unique opportunity to grow with an expanding organization while making an immediate impact on clinical supply operations.&nbsp; This role is ideal for a clinical supply professional who thrives in a matrixed team, brings strong organizational and system skills, and is looking to contribute meaningfully while growing with the organization. The role requires hands-on involvement across multiple vendors, systems (including IRT), and clinical programs. This role may be based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel.&nbsp; Your work will primarily encompass: &nbsp;&nbsp; Production &amp; Project Coordination Develop and maintain template timelines for clinical supply activities, including production, packaging, labeling, and release Track project deliverables and help hold internal teams and external vendors accountable to key milestones Provide light-touch oversight of Drug Substance and Drug Product production schedules to ensure alignment with downstream packaging and labeling timelines Support lot genealogy tracking and documentation across supply chain stages Labeling &amp; Release Support execution of clinical labeling jobs through to release, including coordination with CMOs and internal QA Collaborate on label text development and approval process, as needed Inventory &amp; IRT Support Develop and maintain a consolidated inventory report across all CMOs, integrating data from IRT systems where possible Assist with inventory reconciliation between IRT records and physical inventory at CMOs Support study-level returns and destruction activities in coordination with vendors and QA Provide IRT system support, including setup coordination, UAT, and ongoing data monitoring; experience with IRT system Suvoda and/or 4G is a plus Logistics &amp; Documentation Assist with logistics coordination, including completion of vendor onboarding forms and shipment-related documentation Support the TE (temperature excursion) process in collaboration with QA and vendors Process Improvement&nbsp; Serve as an agent for process improvement, helping to standardize workflows and improve efficiency across multiple CMOs and third-party vendors&nbsp; Contribute to development and refinement of SOPs, templates, and cross-functional best practices within Clinical Supplies Ideal Candidate Profile &gt;&gt;&gt;&nbsp;&nbsp; A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.&nbsp; Knowledge Bachelor’s degree is required, a degree in Life Sciences, Supply Chain, or related discipline is preferred&nbsp; Familiarity with inventory reconciliation, returns, destruction, and TE documentation processes&nbsp; Experience 6+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management is required&nbsp; Demonstrated experience with IRT systems (experience with specific platforms Suvoda and/or 4G is a plus)&nbsp; Experience supporting clinical packaging, labeling, and logistics&nbsp; Experience managing inventory and data across multiple CMOs or external partners&nbsp; Exposure to both early and late phase clinical supply chain needs.&nbsp; Solid global shipping and customs experience&nbsp; Hands-on experience and troubleshooting proficiency with QMS and purchasing systems&nbsp; Attributes Strong organizational and project coordination skills; comfortable managing timelines and tracking tasks across teams&nbsp; Ability to work collaboratively under the guidance of senior leadership and within a cross-functional, vendor-heavy environment&nbsp; Comfortable using Excel, Smartsheet, or project tracking tools to consolidate and present data clearly&nbsp; Excellent verbal and written communication and skills&nbsp; Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines&nbsp; A commitment to excellence&nbsp; Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization&nbsp; The base pay range for this position is expected to be $180,000 - $190,000&nbsp;annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-CK1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Senior Manager, Clinical Supply Chain

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.Vice President, Commercial Strategy and Operations&nbsp; Olema Oncology is seeking a dynamic and experienced commercial leader to serve as Vice President, Commercial Strategy and Operations as the company’s first commercial hire. You will set the foundation and ready the company for a successful potential commercial launch in late 2027. Reporting to the Chief Operating and Financial Officer, you will play a pivotal role in shaping and executing the company’s first product launch in the United States by establishing the commercial strategy and infrastructure to enable future growth.&nbsp; You will design and implement the launch strategy, build the initial commercial operations team and act as the commercial voice across the organization. This is a unique opportunity to join at a transformational moment, guiding Olema through the transition from development-stage biotech to launch-ready organization, and directly influencing patient access, market success, and long-term growth.&nbsp;&nbsp; This role may be based out of either our San Francisco, CA or Cambridge, MA office. Scope of the Role: Lead a Historic First Launch: Guide Olema through its pivotal first product launch, ensuring the organization is fully prepared to deliver innovative therapies to patients.&nbsp; Shape Market Success: Establish the product’s unique value proposition, build trusted relationships with payers and stakeholders, and create the conditions for broad patient access.&nbsp; Build What Doesn’t Yet Exist: Design the commercial foundation from systems to talent that will scale with the company as it transitions from pre-launch to a fully integrated biotech.&nbsp; Harness Insights Through Analytics: Establish commercial analytics and forecasting capabilities to generate actionable insights, enabling data-driven decision-making and effective launch execution.&nbsp; Be the Commercial Voice at the Table: Serve as a key member of Olema’s leadership team, influencing corporate strategy and representing Olema externally with credibility and vision. As Vice President, Commercial Strategy and Operations, you will be responsible for:&nbsp;&nbsp; Commercial Strategy &amp; Launch Execution&nbsp; Define and lead the go-to-market strategy for the company’s first product, including positioning, target segments, pricing, and access considerations.&nbsp; Drive launch readiness planning across functions, ensuring alignment of timelines, deliverables, and success metrics.&nbsp; Develop forecasts and prepare to assume P&amp;L accountability post-approval, ensuring commercial plans are financially sound and scalable.&nbsp; &nbsp;Market Development &amp; Patient Access&nbsp; Lead disease education and market development initiatives to shape the therapeutic landscape in advance of launch.&nbsp; In partnership with Medical Affairs, build and execute KOL and advocacy engagement strategies.&nbsp; Define the initial product value proposition and pricing approach; partner with external experts and consultants to prepare payer engagement plans.&nbsp; Ensure eligible patients are identified and supported with access to therapy; anticipate and resolve implementation hurdles.&nbsp; Cross-Functional Leadership&nbsp; Serve as the commercial voice within cross-functional leadership, partnering with Clinical, Regulatory, Medical, and Manufacturing to ensure launch-ready execution.&nbsp; Provide commercial input into clinical development and regulatory strategy to align with payer, provider, and patient needs.&nbsp; Collaborate with colleagues and external partners to ensure alignment as the company expands beyond the US.&nbsp; Serve as a member of the executive leadership team and represent the commercial function in senior forums.&nbsp; Team &amp; Talent Development&nbsp; Recruit, lead, and mentor the initial commercial team, building a lean organization capable of scaling as the company transitions to launch.&nbsp; Establish a culture of continuous development, emphasizing commercial competencies, capability building, and succession planning.&nbsp; Infrastructure, Change Management &amp; Project Oversight&nbsp; Establish the foundational commercial infrastructure (CRM systems, demand planning, distribution channels, analytics, training) in a staged, resource-appropriate manner.&nbsp; Identify and prioritize future capabilities needed for launch (e.g., market access, HEOR, field teams) and lead a phased build of those functions.&nbsp; Build a commercial analytics capability to generate actionable insights on market trends, physician adoption, and patient access, enabling data-driven decision-making across the organization.&nbsp; Use forecasting and analytics to track launch readiness, measure performance against key milestones, and inform executive decision-making.&nbsp; External Engagement &amp; Partnerships&nbsp; Develop relationships with payers, advocacy groups, distribution partners, and other stakeholders critical for launch success.&nbsp; Provide commercial insights to support business development and licensing discussions.&nbsp; Maintain industry awareness regarding market trends, competitive dynamics, product acceptance, and new product releases.&nbsp; As a seasoned commercial leader who thrives in dynamic, fast-paced biotech environments you will come with the following experience:&nbsp;&nbsp;&nbsp; 15+ years of biotech or pharmaceutical experience with strong grounding in oncology with a strong preference for experience in breast cancer.&nbsp;&nbsp; Bachelor's degree in business, Life Sciences, or a related field is required; a master's degree (MBA or advanced degree in a scientific discipline) is strongly preferred.&nbsp; Extensive experience building, managing, and leading a high-performing team/s, with demonstrated ability to recruit, develop, and mentor talent while establishing the strategy, infrastructure, and operations required to drive a successful product launch.&nbsp; A demonstrated track record of preparing for and executing first commercial launches in emerging biotech settings.&nbsp; Deep experience shaping go-to-market strategies, leading launch planning, and differentiating products in competitive markets.&nbsp; Expertise in defining product value propositions and partnering with external experts to shape pricing, market access, and reimbursement strategies.&nbsp; Experience building and leveraging commercial analytics and forecasting capabilities to generate insights that guide launch planning, market strategy, and executive decision-making.&nbsp; A strong understanding of how commercial strategy integrates with clinical development, regulatory pathways and manufacturing and supply.&nbsp; Proven ability to build and scale commercial teams, with a leadership style that inspires, mentors, and sets cultural tone.&nbsp; Hands-on experience establishing commercial infrastructure to support launch, including CRM systems, forecasting, analytics, and distribution planning.&nbsp; Strong financial and analytical acumen, with prior accountability for forecasting and preparation for P&amp;L responsibility.&nbsp; Established relationships and credibility working with KOLs, advocacy groups, payers, and healthcare stakeholders.&nbsp; Executive presence and experience representing the commercial perspective both internally as part of senior leadership and externally with partners, payers, and investors.&nbsp; An entrepreneurial mindset and demonstrated success operating as a first or early commercial hire, transforming organizations from development-stage to launch-ready.&nbsp; The base pay range for this position is expected to be $300,000 - $350,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-AD1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

Vice President, Commercial Strategy and Operations

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.Vice President, Commercial Strategy and Operations&nbsp; Olema Oncology is seeking a dynamic and experienced commercial leader to serve as Vice President, Commercial Strategy and Operations as the company’s first commercial hire. You will set the foundation and ready the company for a successful potential commercial launch in late 2027. Reporting to the Chief Operating and Financial Officer, you will play a pivotal role in shaping and executing the company’s first product launch in the United States by establishing the commercial strategy and infrastructure to enable future growth.&nbsp; You will design and implement the launch strategy, build the initial commercial operations team and act as the commercial voice across the organization. This is a unique opportunity to join at a transformational moment, guiding Olema through the transition from development-stage biotech to launch-ready organization, and directly influencing patient access, market success, and long-term growth.&nbsp;&nbsp; This role may be based out of either our San Francisco, CA or Cambridge, MA office. Scope of the Role: Lead a Historic First Launch: Guide Olema through its pivotal first product launch, ensuring the organization is fully prepared to deliver innovative therapies to patients.&nbsp; Shape Market Success: Establish the product’s unique value proposition, build trusted relationships with payers and stakeholders, and create the conditions for broad patient access.&nbsp; Build What Doesn’t Yet Exist: Design the commercial foundation from systems to talent that will scale with the company as it transitions from pre-launch to a fully integrated biotech.&nbsp; Harness Insights Through Analytics: Establish commercial analytics and forecasting capabilities to generate actionable insights, enabling data-driven decision-making and effective launch execution.&nbsp; Be the Commercial Voice at the Table: Serve as a key member of Olema’s leadership team, influencing corporate strategy and representing Olema externally with credibility and vision. As Vice President, Commercial Strategy and Operations, you will be responsible for: &nbsp; Commercial Strategy &amp; Launch Execution&nbsp; Define and lead the go-to-market strategy for the company’s first product, including positioning, target segments, pricing, and access considerations.&nbsp; Drive launch readiness planning across functions, ensuring alignment of timelines, deliverables, and success metrics.&nbsp; Develop forecasts and prepare to assume P&amp;L accountability post-approval, ensuring commercial plans are financially sound and scalable.&nbsp; &nbsp;Market Development &amp; Patient Access&nbsp; Lead disease education and market development initiatives to shape the therapeutic landscape in advance of launch.&nbsp; In partnership with Medical Affairs, build and execute KOL and advocacy engagement strategies.&nbsp; Define the initial product value proposition and pricing approach; partner with external experts and consultants to prepare payer engagement plans.&nbsp; Ensure eligible patients are identified and supported with access to therapy; anticipate and resolve implementation hurdles.&nbsp; Cross-Functional Leadership&nbsp; Serve as the commercial voice within cross-functional leadership, partnering with Clinical, Regulatory, Medical, and Manufacturing to ensure launch-ready execution.&nbsp; Provide commercial input into clinical development and regulatory strategy to align with payer, provider, and patient needs.&nbsp; Collaborate with colleagues and external partners to ensure alignment as the company expands beyond the US.&nbsp; Serve as a member of the executive leadership team and represent the commercial function in senior forums.&nbsp; Team &amp; Talent Development&nbsp; Recruit, lead, and mentor the initial commercial team, building a lean organization capable of scaling as the company transitions to launch.&nbsp; Establish a culture of continuous development, emphasizing commercial competencies, capability building, and succession planning.&nbsp; Infrastructure, Change Management &amp; Project Oversight&nbsp; Establish the foundational commercial infrastructure (CRM systems, demand planning, distribution channels, analytics, training) in a staged, resource-appropriate manner.&nbsp; Identify and prioritize future capabilities needed for launch (e.g., market access, HEOR, field teams) and lead a phased build of those functions.&nbsp; Build a commercial analytics capability to generate actionable insights on market trends, physician adoption, and patient access, enabling data-driven decision-making across the organization.&nbsp; Use forecasting and analytics to track launch readiness, measure performance against key milestones, and inform executive decision-making.&nbsp; External Engagement &amp; Partnerships&nbsp; Develop relationships with payers, advocacy groups, distribution partners, and other stakeholders critical for launch success.&nbsp; Provide commercial insights to support business development and licensing discussions.&nbsp; Maintain industry awareness regarding market trends, competitive dynamics, product acceptance, and new product releases.&nbsp; As a seasoned commercial leader who thrives in dynamic, fast-paced biotech environments you will come with the following experience:&nbsp;&nbsp;&nbsp; 15+ years of biotech or pharmaceutical experience with strong grounding in oncology with a strong preference for experience in breast cancer.&nbsp;&nbsp; Bachelor's degree in business, Life Sciences, or a related field is required; a master's degree (MBA or advanced degree in a scientific discipline) is strongly preferred.&nbsp; Extensive experience building, managing, and leading a high-performing team/s, with demonstrated ability to recruit, develop, and mentor talent while establishing the strategy, infrastructure, and operations required to drive a successful product launch.&nbsp; A demonstrated track record of preparing for and executing first commercial launches in emerging biotech settings.&nbsp; Deep experience shaping go-to-market strategies, leading launch planning, and differentiating products in competitive markets.&nbsp; Expertise in defining product value propositions and partnering with external experts to shape pricing, market access, and reimbursement strategies.&nbsp; Experience building and leveraging commercial analytics and forecasting capabilities to generate insights that guide launch planning, market strategy, and executive decision-making.&nbsp; A strong understanding of how commercial strategy integrates with clinical development, regulatory pathways and manufacturing and supply.&nbsp; Proven ability to build and scale commercial teams, with a leadership style that inspires, mentors, and sets cultural tone.&nbsp; Hands-on experience establishing commercial infrastructure to support launch, including CRM systems, forecasting, analytics, and distribution planning.&nbsp; Strong financial and analytical acumen, with prior accountability for forecasting and preparation for P&amp;L responsibility.&nbsp; Established relationships and credibility working with KOLs, advocacy groups, payers, and healthcare stakeholders.&nbsp; Executive presence and experience representing the commercial perspective both internally as part of senior leadership and externally with partners, payers, and investors.&nbsp; An entrepreneurial mindset and demonstrated success operating as a first or early commercial hire, transforming organizations from development-stage to launch-ready.&nbsp; The base pay range for this position is expected to be $300,000 - $350,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.&nbsp; #LI-AD1Important Information &gt;&gt;&gt; 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: &nbsp;We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;olema.com; our careers page is&nbsp;olema.com/careers; our LinkedIn page is&nbsp;linkedin.com/company/olema-oncology.&nbsp;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&nbsp;of any kind, and does not make job offers without an in-person interview.

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