About the Role >>> Senior Director, International Finance and Operations 

The Senior Director, International Finance & Operations will lead the establishment and ongoing finance operations of the Company’s Ireland entity. This role is responsible for building finance infrastructure, ensuring compliance with Irish and EU requirements, and supporting integration with global financial systems. 

Reporting to the VP of Finance, this individual will serve as a key execution partner in delivering the Company’s international expansion into Ireland, a critical strategic priority. This role will work cross-functionally with internal stakeholders and external advisors to drive timely, coordinated execution across all aspects of the entity build-out and ongoing operations, including but not limited to finance operations, indirect tax compliance, and local governance. 

This role is based out of our Dublin, Ireland office and will require 10% travel. 

Your role will primarily encompass: 

Ireland Entity Setup & Execution  

• Lead execution of the Ireland entity build-out in coordination with internal teams and external partners  
• Drive implementation of cross-functional workplans, ensuring alignment with key milestones and timelines 
• Manage interdependencies across Finance, Legal, HR, IT, and external advisors 
• Develop and maintain project plans, timelines, and key milestones  
• Track progress against deliverables, proactively identify risks or delays, and drive resolution with Finance leadership  
• Indirect Tax & VAT Compliance 
• Oversee VAT registration and ongoing indirect tax compliance in Ireland/EU  
• Coordinate with external advisors on VAT filings and regulatory requirements  
• Ensure timely and accurate preparation and submission of VAT returns  
• Establish and maintain documentation, processes, and controls to support compliance and audit readiness  
• Identify and escalate tax-related risks and technical issues and process gaps 

Finance Operations & Infrastructure 

• Lead the establishment and oversight of finance operations for the Ireland entity, including payroll, local compliance, and financial processes  
• Oversee payroll setup and ongoing coordination with HR and external providers  
• Ensure payroll and related processes are accurate, compliant, and timely  
• Support integration of the Ireland entity into global financial systems, reporting, and internal controls  
• Implement global finance policies in alignment with local regulatory requirements  

Stakeholder Management & Cross-Functional Execution 

• Act as a central point of coordination across cross-functional stakeholders and external partners to support execution of Ireland-related activities  
• Drive alignment, clarity, and accountability across teams 
• Lead cross-functional meetings, track decisions, and ensure follow-through on key action items  
• Provide regular updates to Finance leadership on status, risks, and timelines  

Finance Processes & Controls 

• Establish and document finance processes and internal controls for a new entity  
• Support development of scalable processes as operations grow  
• Ensure alignment with U.S. reporting requirements and internal control frameworks, including SOX readiness, to ensure transition from setup to steady-state operations 

Additional Responsibilities 

• Support additional finance, tax, and operational initiatives as needed  
• Assist in preparation of materials for leadership review and decision-making 
• Act as a key execution partner to the VP of Finance in delivering the Ireland expansion initiative 
• Support prioritization, issue resolution, and cross-functional alignment across workstreams  

Ideal Candidate Profile  

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: 

• Bachelor’s Degree in Finance, Accounting, or related field (required) 
• CPA, ACA, ACCA, or equivalent (required) 
• Strong understanding of finance operations, accounting principles, and internal controls 
•  Familiarity with indirect tax/VAT in Ireland and/or EU 
• Knowledge of SOX compliance and public company financial environments (preferred) 

Experience: 

• Minimum of 12+ years of experience in finance, accounting, or related roles 
• Minimum of 3+ years in leading and managing teams 
• Experience in biotech, pharma, or life sciences (required)  
• Experience supporting international operations and/or entity setup 
• Experience working with external advisors (e.g., tax, payroll, legal) 
• Strong project management experience across cross-functional initiatives 
• Experience building or scaling finance processes and controls 
• Experience supporting integration into financial systems and reporting structures 
• Exposure to indirect tax/VAT compliance and filings 
• Experience in a SOX-compliant or public company environment (required)

Additional Attributes: 

• Strong project management and organizational skills 
• Ability to operate in a fast-paced, evolving environment 
• Strong communication and stakeholder management skills 
• Execution-oriented mindset  

#LI-MK1

About the Role >>> Submission Content Manager, Regulatory Operations 

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments). 

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment. 

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

Document Preparation & Formatting 

• Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
• Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
• Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
• Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively

 Submission Assembly Support 

• Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
• Coordinate with submission teams to confirm final document versions and readiness for publishing
• Track and document issues, risks, and deviations, escalating as appropriate
• Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness

Quality Control & Compliance 

• Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
• Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing 
• Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

Ideal Candidate Profile >>>  

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: 

• Bachelor’s degree is required 
• Knowledge and experience of eCTD submissions 
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM 
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• 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 and operational perspectives  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 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-CK1

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

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:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $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-MK1

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

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:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $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-MK1

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

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: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 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-CK1

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

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: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 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-CK1

As the Synthetic Medicinal Chemistry Intern reporting to the Principal Research Associate, you will gain hands-on organic chemistry laboratory experience within a biotechnology environment working alongside our Medicinal Chemistry team. This role offers the opportunity to learn how to conduct organic chemistry experiments to synthesize compounds that will be evaluated in biological assays, contributing directly to ongoing research efforts. 

This position is a 10-week paid summer internship $22/hour working 40 hours a week onsite at our San Francisco facility. The internship dates are June 8 through August 14.  

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Your work will primarily encompass: 

• Synthesizing, purifying, and characterizing small molecules in support of Olema drug discovery programs 
• Conducting laboratory experiments in consultation with Chemistry team members 
• Utilizing databases such as Reaxys or SciFinder to design and plan your experiments 
• Acquiring and interpreting analytical data (eg. HPLC, LCMS, and NMR) 
• Keeping excellent records of experimental procedures and acquired data in lab notebook 
• Summarizing and presenting your experimental findings in group meetings 

Ideal Candidate Profile >>> Highly Motivated Student Studying Synthetic Organic Chemistry (or Closely Related Field) 

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. 

Qualifications:

• Currently enrolled in a 4-year undergraduate program or 2026 graduate, required 
• Currently a standing junior or senior, required 
• Currently majoring in and/or taking Chemistry classes or closely related field of study, required 
• Taken undergraduate-level Organic Chemistry; 2 semesters prior to the start of the internship, required 
• Previous hands-on laboratory experience in Organic Chemistry, strongly preferred 
• Currently working in a research lab, strongly preferred 

Attributes: 

• Organized and detail-oriented 
• Highly self-motivated with a strong desire to learn 
• Strong interest in medicinal chemistry and drug discovery

The base pay for this position is $22/hour. 

#LI-SF1

About the Role >>> Senior Manager, Legal Operations & Contracts  

As the Senior Manager, Legal Operations & Contracts reporting to the Vice-President, Legal Counsel, you will bring strong legal operations expertise, including process management, execution, compliance, and process optimization, with a focus on building and scaling efficient workflows. In addition, you bring a deep background in drafting, reviewing, and negotiating a high volume of both routine and complex contracts. This role will operate independently across functions as a trusted partner, proactively managing the end-to-end contract lifecycle for commercialization contracts while driving operational excellence and efficiency. 

This role will support the legal team through KPI tracking, metrics, and analysis, while identifying and driving workflow efficiencies as the function scales. This role requires strong legal knowledge, the ability to work independently, and to build and maintain cross-functional relationships. The ideal candidate is detail-oriented, highly organized, and proficient with systems and tools, with a solid understanding of corporate contracts. Strong communication, collaboration, and time management skills are essential, along with a proactive, positive, and growth-oriented mindset. 

This role is based out of our San Francisco or Boston office and will require 10% travel. 

Your work will primarily encompass: 

• Manage legal operations activities including contributing to the development of training materials, documentation, and process improvements to support efficient contracting practices
• Lead and optimize legal operations processes such as contract management, document management, knowledge management, vendor relationships, and strategic processes
• Drive operational efficiencies through technology and process improvements, managing legal department projects, and support day-to-day operations
• Develop and implement policies and procedures to improve legal department effectiveness and efficiency
• Negotiate, draft, review, and manage a wide range of contracts. (including confidentiality agreements, SOWs, consulting and service agreements, materials transfer agreements, sponsored research agreements, clinical study agreements, and various vendor services agreements) with guidance from senior attorneys as needed
• Communicate with internal stakeholders regarding contractual risks and support development of practical mitigation approaches
• Ensure contractual terms and conditions are consistent with Olema policies, standards, and established guidance
• Ensure compliance with applicable laws and regulations, including data protection and privacy requirements (e.g., GDPR, HIPAA)
• Serve as an escalation point of contact for internal and external contract process/status questions and escalate more complex issues as appropriate 
• Manage contract workflow and support adherence to contract turnaround timelines to ensure efficient execution
• Support and partner in the development, enhancement, and maintenance of contract templates and SOPs
• Be the contract management systems expert (i.e. Agiloft)
• Coordinate with outside counsel and in-house legal team to obtain legal documents, e.g., patent declarations and assignments, and manage legal records

Ideal Candidate Profile >>>  

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: 

• Bachelor’s Degree, is required 
• Paralegal certificate or legal studies background preferred
• Demonstrated experience leading legal operations, including contract lifecycle management, process optimization, and implementation of tools and systems to improve efficiency
• Managing full contract lifecycle, including drafting, negotiating, editing, and execution, with a strong understanding of contract terms, structure, and end-to-end contract management processes (tracking, approval, and execution) 
• Knowledge or experience with paralegal support tasks, with a focus on compliance program matter, contract or corporate matters
• Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred
• Proficiency with contract management software 

Experience: 

• A minimum of seven years (7+) of relevant experience in legal operations and contract management
• In-house experience at a biotechnology, pharmaceutical or life science company with a focus on legal operations and agreement drafting and negotiation, strongly preferred
• Demonstrated experience working with attorneys and senior leaders across various functions
• Ability to work both independently and effectively across a variety of functional groups (such as Commercial, Research and Development, CMC, Human Resources, Finance, Facilities and IT) and all levels of management
• Liaison and point of contact for business contract owners and vendor/agency inquiries related to contracting and payment in partnership with legal, finance, and procurement
• Strong technical skills (e.g., Microsoft Word, Excel and PowerPoint, Contract Management Systems, Docusign)

Attributes: 

• Highly organized, detail-oriented, and process driven 
• Proactive and solutions-oriented 
• Strong collaborator with the ability to influence cross-functional teams 
• Comfortable operating in a growing, fast-paced biotech environment 
• High level of integrity and discretion 
• Flexible and willing to learn new procedures and skill sets

The base pay range for this position is expected to be $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-MT1

About the Role >>> Senior Manager, Legal Operations & Contracts  

As the Senior Manager, Legal Operations & Contracts reporting to the Vice-President, Legal Counsel, you will bring strong legal operations expertise, including process management, execution, compliance, and process optimization, with a focus on building and scaling efficient workflows. In addition, you bring a deep background in drafting, reviewing, and negotiating a high volume of both routine and complex contracts. This role will operate independently across functions as a trusted partner, proactively managing the end-to-end contract lifecycle for commercialization contracts while driving operational excellence and efficiency. 

This role will support the legal team through KPI tracking, metrics, and analysis, while identifying and driving workflow efficiencies as the function scales. This role requires strong legal knowledge, the ability to work independently, and to build and maintain cross-functional relationships. The ideal candidate is detail-oriented, highly organized, and proficient with systems and tools, with a solid understanding of corporate contracts. Strong communication, collaboration, and time management skills are essential, along with a proactive, positive, and growth-oriented mindset. 

This role is based out of our San Francisco or Boston office and will require 10% travel. 

Your work will primarily encompass: 

• Manage legal operations activities including contributing to the development of training materials, documentation, and process improvements to support efficient contracting practices
• Lead and optimize legal operations processes such as contract management, document management, knowledge management, vendor relationships, and strategic processes
• Drive operational efficiencies through technology and process improvements, managing legal department projects, and support day-to-day operations
• Develop and implement policies and procedures to improve legal department effectiveness and efficiency
• Negotiate, draft, review, and manage a wide range of contracts. (including confidentiality agreements, SOWs, consulting and service agreements, materials transfer agreements, sponsored research agreements, clinical study agreements, and various vendor services agreements) with guidance from senior attorneys as needed
• Communicate with internal stakeholders regarding contractual risks and support development of practical mitigation approaches
• Ensure contractual terms and conditions are consistent with Olema policies, standards, and established guidance
• Ensure compliance with applicable laws and regulations, including data protection and privacy requirements (e.g., GDPR, HIPAA)
• Serve as an escalation point of contact for internal and external contract process/status questions and escalate more complex issues as appropriate 
• Manage contract workflow and support adherence to contract turnaround timelines to ensure efficient execution
• Support and partner in the development, enhancement, and maintenance of contract templates and SOPs
• Be the contract management systems expert (i.e. Agiloft)
• Coordinate with outside counsel and in-house legal team to obtain legal documents, e.g., patent declarations and assignments, and manage legal records

Ideal Candidate Profile >>>  

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: 

• Bachelor’s Degree, is required 
• Paralegal certificate or legal studies background preferred
• Demonstrated experience leading legal operations, including contract lifecycle management, process optimization, and implementation of tools and systems to improve efficiency
• Managing full contract lifecycle, including drafting, negotiating, editing, and execution, with a strong understanding of contract terms, structure, and end-to-end contract management processes (tracking, approval, and execution) 
• Knowledge or experience with paralegal support tasks, with a focus on compliance program matter, contract or corporate matters
• Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred
• Proficiency with contract management software 

Experience: 

• A minimum of seven years (7+) of relevant experience in legal operations and contract management
• In-house experience at a biotechnology, pharmaceutical or life science company with a focus on legal operations and agreement drafting and negotiation, strongly preferred
• Demonstrated experience working with attorneys and senior leaders across various functions
• Ability to work both independently and effectively across a variety of functional groups (such as Commercial, Research and Development, CMC, Human Resources, Finance, Facilities and IT) and all levels of management
• Liaison and point of contact for business contract owners and vendor/agency inquiries related to contracting and payment in partnership with legal, finance, and procurement
• Strong technical skills (e.g., Microsoft Word, Excel and PowerPoint, Contract Management Systems, Docusign)

Attributes: 

• Highly organized, detail-oriented, and process driven 
• Proactive and solutions-oriented 
• Strong collaborator with the ability to influence cross-functional teams 
• Comfortable operating in a growing, fast-paced biotech environment 
• High level of integrity and discretion 
• Flexible and willing to learn new procedures and skill sets

The base pay range for this position is expected to be $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-MT1

About the Role >>>  Associate Director, Clinical Supply Chain 

As the Associate Director of Clinical Supply Chain reporting to the Vice President, Clinical Supply Chain, you will plan, create, implement, build, and optimize the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Olema’s clinical programs.    

This role is available in either our San Francisco or Cambridge office and will require about 15% domestic or international travel.

Your work will primarily encompass:  

• End to End clinical supply chain management   
• Develop and implement global Clinical Supply Chain strategies  
• Manage global inventories, shipping, and third-party manufacturers / logistics providers  
• Develop and manage Interactive Response Technologies (IRT) systems  
• Oversight packaging, labeling, and distribution activities at multiple vendors  
• Generate and manage clinical labels  
• Identify supply chain risks, escalate if needed, and close out risk items  
• Partner with Clinical Operations to align on assumptions and build clinical supply to meet program demand  
• Represent Clinical Supply Chain on study execution teams 

Knowledge:  

• Bachelor's degree is required, Master’s degree is preferred   
• Late phase clinical development and clinical supply chain management  
• Thorough knowledge of Good Manufacturing Practices (GMP)  

Experience:  

• 8+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management  
• Inventory management and third-party logistics oversight experience  
• Extensive experience managing forecast demands  
• Prior experience managing global, large, late-stage studies with standard of care drugs  
• Strong global shipping and customs experience  
• Solid experience developing clinical labels  
• Experience developing IRT specifications  
• Hands-on experience and troubleshooting proficiency with QMS and purchasing systems  
• Prior experience in oncology trials using small molecules is preferred   
• Excellent project management skills  

Attributes:  

• Excellent verbal and written communication and skills  
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines  
• A commitment to excellence  
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization  
• 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  
• Entrepreneurial mindset and the ability to prioritize key work streams and requirements that will change over the near and mid-term  
• A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required  
• Be a “difference maker” in terms of one’s professionalism and contributions  
• Have impeccable professional ethics, integrity and judgment  
• Be collegial, hard-working, confident, a self-starter and have a passion for results 

The base pay range for this position is expected to be $185,000 - $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. 

#LI-CK1

About the Role >>>  Associate Director, Clinical Supply Chain 

As the Associate Director of Clinical Supply Chain reporting to the Vice President, Clinical Supply Chain, you will plan, create, implement, build, and optimize the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Olema’s clinical programs.    

This role is available in either our San Francisco or Cambridge office and will require about 15% domestic or international travel.

Your work will primarily encompass:  

• End to End clinical supply chain management   
• Develop and implement global Clinical Supply Chain strategies  
• Manage global inventories, shipping, and third-party manufacturers / logistics providers  
• Develop and manage Interactive Response Technologies (IRT) systems  
• Oversight packaging, labeling, and distribution activities at multiple vendors  
• Generate and manage clinical labels  
• Identify supply chain risks, escalate if needed, and close out risk items  
• Partner with Clinical Operations to align on assumptions and build clinical supply to meet program demand  
• Represent Clinical Supply Chain on study execution teams 

Knowledge:  

• Bachelor's degree is required, Master’s degree is preferred   
• Late phase clinical development and clinical supply chain management  
• Thorough knowledge of Good Manufacturing Practices (GMP)  

Experience:  

• 8+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management  
• Inventory management and third-party logistics oversight experience  
• Extensive experience managing forecast demands  
• Prior experience managing global, large, late-stage studies with standard of care drugs  
• Strong global shipping and customs experience  
• Solid experience developing clinical labels  
• Experience developing IRT specifications  
• Hands-on experience and troubleshooting proficiency with QMS and purchasing systems  
• Prior experience in oncology trials using small molecules is preferred   
• Excellent project management skills  

Attributes:  

• Excellent verbal and written communication and skills  
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines  
• A commitment to excellence  
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization  
• 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  
• Entrepreneurial mindset and the ability to prioritize key work streams and requirements that will change over the near and mid-term  
• A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required  
• Be a “difference maker” in terms of one’s professionalism and contributions  
• Have impeccable professional ethics, integrity and judgment  
• Be collegial, hard-working, confident, a self-starter and have a passion for results 

The base pay range for this position is expected to be $185,000 - $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. 

#LI-CK1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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-AD1

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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-AD1

About the Role >>> Sr Director, Commercial Manufacturing & Operations

As the Sr Director, Commercial Manufacturing & Operations reporting to the SVP of CMC & Supply Chain, you will be an experienced manager with a track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances and drug products. You will be responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, quality event support, etc. for drug substances and drug product.

This role is based out of our Boston, USA and will require 20% travel.

Your work will primarily encompass:

· Support the US launch of palazestrant in 2027 by creating the commercial supply platform and strategy

· Establish an operational commercial mapping of supply and partners (state licenses, 3PL & order-to-cash Services, shipping and import/export logistics, import/export compliance)

· Provide technical and functional project leadership on drug substance (DS) and drug product (DP) commercial manufacturing, and CMO management

· Develop business processes and systems to support and streamline all DS and DP commercial activities. Work globally to implement processes and systems within Olema’s global CDMO network. Develop metrics and continuous improvement initiatives.

· Ensure employees are engaged and tied to the global Olema’s business strategy

· Lead or manage documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition

· Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations

· Partner with Commercial, Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate commercial procedures to ensure the drug substance and drug product meets established quality standards and adheres to established and regulatory agency approved parameters

· Work closely with SMEs and CMOs to execute shipment of drug substance batches and drug product lots

· Partner with supply chain teams to design DS and DP production schedules while maximizing production and cost efficiencies

· Develop, maintain and communicate product manufacturing plans, timelines, milestones and budgets. Integrate and align commercial manufacturing activities with corporate development program objectives. Develop and apply resource and capacity models

· Stay current with state-of-the art approaches and applicable global regulations and industry standards

Ideal Candidate Profile >>>

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 and experience:

· BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization

· Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function

· Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges

· Visionary as well as tactile and concrete at an operational level.

· Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role

· Broad experience working with CDMOs and managing external development and manufacturing partners

· Expertise in oversight of GMP manufacturing, including tech transfer and process validation

· Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations

· Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances

· Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing

· Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management

· Effective written, oral communication and interpersonal skills

Attributes:

· 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.

· Specific personal characteristics include:

o Highly analytical and detail oriented

o Self-Starter

o Goal and data driven

o Ability to multi-task and shift priorities rapidly to meet tight deadlines

o Aspires to the highest scientific and ethical standards

o Keen to improve processes and overcome inefficiencies

The base pay range for this position is expected to be $225,000 - $250,000 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-MK1

#LI-MK1

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

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: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 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-CK1

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

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: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 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-CK1

About the Role >>> Vice President, Market Access

As the Vice President of Market Access, you will build and lead the market access organization and capabilities critical to Olema’s mission to bring better medicines to breast cancer patients. This leader will have a significant role in preparing the company and the market for the launch of Olema’s lead product, palazestrant, a novel SERD/CERAN being evaluated in ER+ HER2- metastatic breast cancer.

The leadership scope spans all aspects of U.S. market access—payor and account engagement, pricing, coverage and reimbursement, distribution, and patient support programs. The ideal candidate brings deep market access expertise in oral oncology therapeutics and has demonstrated success building infrastructure from the ground up, delivering value in competitive markets, and thriving in a fast-paced, resource-conscious biotech environment.

This role is based out of our San Francisco, CA or Boston, MA office and will require travel as needed.

Your work will primarily encompass:

• Establishing the infrastructure and capabilities needed to support the potential US launch of palazestrant
• Developing and executing strategy across payor and account access, pricing, coverage and reimbursement, trade and distribution, and patient support
• Developing payer value propositions and evidence plans that support coverage and adoption
• Leading payor and account engagement across all relevant channels
• Shaping pricing and contracting strategy, including gross-to-net considerations and channel strategy
• Setting up and managing trade and distribution strategy, including specialty pharmacy and specialty distributor network design and partner selection
• Building patient support programs that reduce barriers for patients and providers
• Partnering cross-functionally with Marketing, Commercial Strategy and Operations, Sales, Medical Affairs, Regulatory, Finance, Legal, Manufacturing, and Supply Chain
• Building and mentoring a high-performing team in a fast-paced, growing biotech environment

Ideal Candidate Profile

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

• Bachelor’s degree required; advanced degree preferred
• Strong understanding of US payor, pricing, reimbursement, specialty pharmacy, and distribution dynamics
• Deep expertise in oncology market access, specifically for oral therapeutics

Experience

• Minimum of 15+ years of biopharmaceutical experience, including significant market access leadership experience
• Proven success building market access team and infrastructure in a first-time launching company or similar pre-commercial biotech setting
• Experience developing strategies to win in competitive markets
• Experience thriving in a small company environment, with a hands-on and pragmatic leadership style

Attributes

• Team player and collaborative: puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• People developer: balances team and individual responsibilities; gives and welcomes feedback
• Possesses a get-the-job done attitude and identifies not just challenges but takes the initiative to identify solutions
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent written verbal and interpersonal communication skills and ability to adapt communication styles to varied internal and external partners
• Impeccable professional ethics, integrity, and judgment

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.

#LI-AD1

About the Role >>> Lead Senior Medical Writer 

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

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: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• 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
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 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-MT1

About the Role >>> Lead Senior Medical Writer

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

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: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• 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
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 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-MT1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

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.  

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: 

• 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  

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: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working withCROs and other partners

Attributes: 

• 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 $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-MK1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

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.  

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: 

• 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  

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: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working with CROs and other partners

Attributes: 

• 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 $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-MK1

About the Role >>> Associate Director, Analytical Development  

As the Associate Director of Analytical Development reporting to the Senior Director of Analytical Chemistry you will be responsible for driving progress of both early and late-stage molecules by delivering phase - appropriate analytical methods, validation and tech transfers. You will partner with cross-functionally supporting process development, formulations, CMC, and quality activities. In addition, you will bring demonstrated team playing and collaboration skills and experience operating effectively in a fast-paced, growth-stage biotech environment.

This role can be based out of our San Francisco, CA or Boston, MA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Supporting analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products 
• Conducting analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Working on stability programs, monitoring/trending stability data and establishing retest periods or shelf lives for drug substances or drug products
• Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations 
• Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed  
• Representing analytical Chemistry at internal and external scientific team meetings as needed 
• Staying current with state-of-the art approaches and applicable global regulations and industry standards 

Ideal Candidate Profile >>> 

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

• MS or PhD in Chemistry or equivalent scientific discipline 
• Expertise in analytical development and quality control for both drug substances (emphasis) and drug product 
• Knowledge of cGMP, ICH, and FDA regulations/guidance 

Experience

• Minimum of 7+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration 
• Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects 
• Experience in partnering with cross functional teams providing analytical development leadership across programs and projects 
• Effective written, oral communication and interpersonal skills 

Attributes

• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadline 
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization 
• 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 other 
• Aspires to the highest of scientific and ethical standards 
• Keen to improve processes and overcome inefficiencies 

The base pay range for this position is expected to be $190,000-$205,000 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-MT1

About the Role >>> Associate Director, Analytical Development  

As the Associate Director of Analytical Development reporting to the Senior Director of Analytical Chemistry you will be responsible for driving progress of both early and late-stage molecules by delivering phase - appropriate analytical methods, validation and tech transfers. You will partner with cross-functionally supporting process development, formulations, CMC, and quality activities. In addition, you will bring demonstrated team playing and collaboration skills and experience operating effectively in a fast-paced, growth-stage biotech environment.

This role can be based out of our San Francisco, CA or Boston, MA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Supporting analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products 
• Conducting analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Working on stability programs, monitoring/trending stability data and establishing retest periods or shelf lives for drug substances or drug products
• Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations 
• Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed  
• Representing analytical Chemistry at internal and external scientific team meetings as needed 
• Staying current with state-of-the art approaches and applicable global regulations and industry standards 

Ideal Candidate Profile >>> 

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

• MS or PhD in Chemistry or equivalent scientific discipline 
• Expertise in analytical development and quality control for both drug substances (emphasis) and drug product 
• Knowledge of cGMP, ICH, and FDA regulations/guidance 

Experience

• Minimum of 7+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration 
• Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects 
• Experience in partnering with cross functional teams providing analytical development leadership across programs and projects 
• Effective written, oral communication and interpersonal skills 

Attributes

• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadline 
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization 
• 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 other 
• Aspires to the highest of scientific and ethical standards 
• Keen to improve processes and overcome inefficiencies 

The base pay range for this position is expected to be $190,000-$205,000 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-MT1

About the Role >>> Senior Manager, Quality Document Control and Compliance 

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel. 

Your work will primarily encompass: 

• Serving as Veeva Vault QDocs Administrator and document control manager  
• Processing document change control (DCC) in Veeva for GxP controlled documents
• Formatting the finalized documents to ensure compliance with effective templates 
• Performing proof reading and finalize document for final processing in Veeva QDocs 
• Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives  
• Developing SOPs and WIs to support Quality Systems and Veeva Document control processes 
• Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed 
• Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review. 
• Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
• Performing other duties and complete special projects as required

Ideal Candidate Profile >>> 

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

• Bachelor’s Degree is required
• Experience in managing and maintaining GxP compliance documents and Document Control systems
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections

Experience

• 8+ years of industry experience
• 2+ years as Veeva Vault QDocs Administrator
• Experience in managing and maintaining GxP documents and Document Control systems
• Experience establishing effective KPIs for document management system
• Experience creating and facilitating training for Quality Systems

Attributes

• Strong written and verbal communication and interpersonal skills
• Commitment to supporting internal and external teams and customers
• Demonstrates strong autonomy and initiative
• Meticulous attention to detail and well organized
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation

The base pay range for this position is expected to be $150,000 - $160,000 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-CK1

About the Role >>> Senior Manager, Quality Document Control and Compliance 

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require about 15% travel. 

Your work will primarily encompass: 

• Serving as Veeva Vault QDocs Administrator and document control manager  
• Processing document change control (DCC) in Veeva for GxP controlled documents
• Formatting the finalized documents to ensure compliance with effective templates 
• Performing proof reading and finalize document for final processing in Veeva QDocs 
• Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives  
• Developing SOPs and WIs to support Quality Systems and Veeva Document control processes 
• Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed 
• Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review. 
• Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
• Performing other duties and complete special projects as required

Ideal Candidate Profile >>> 

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

• Bachelor’s Degree is required
• Experience in managing and maintaining GxP compliance documents and Document Control systems
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections

Experience

• 8+ years of industry experience
• 2+ years as Veeva Vault QDocs Administrator
• Experience in managing and maintaining GxP documents and Document Control systems
• Experience establishing effective KPIs for document management system
• Experience creating and facilitating training for Quality Systems

Attributes

• Strong written and verbal communication and interpersonal skills
• Commitment to supporting internal and external teams and customers
• Demonstrates strong autonomy and initiative
• Meticulous attention to detail and well organized
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation

The base pay range for this position is expected to be $150,000 - $160,000 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-CK1

About the Role >>> Senior Director, Marketing

As the Senior Director, Marketing you will design and execute the Commercial roadmap that enables the successful potential U.S. launch of palazestrant, Olema’s lead program currently in Phase 3 for ER+ HER2- metastatic breast cancer. The ideal candidate will have experience in the commercialization of oral oncology therapies in breast cancer and a track record of leading successful oncology drug launches in the US.

This role is based out of our San Francisco office and will require travel as needed.

Your work will primarily encompass:

• Building the strategic marketing plan and leading launch readiness initiatives (branding, positioning, messaging platform, story flow and creative imagery) to deliver a successful palazestrant launch
• Developing, prioritizing, and implementing market development activities that deepen awareness of unmet needs and address knowledge gaps among customers
• Designing the go-to-market approach that delivers resource-efficient customer engagement, customer behavior change and adoption at launch
• Developing KPIs to assess launch performance and analyzing market, customer, and competitor trends, incorporating insights into marketing strategies and plans
• Establishing a strong relationship with Medical Affairs, and eventually, the Sales team and other field-based commercial teams to ensure optimal execution
• Partnering cross-functionally with Clinical Development, Regulatory and other internal stakeholders to gather input for functional activities and ensure alignment with launch readiness activities
• Managing partner agency and vendor relationships and workflow
• Ensuring strategic and tactical plans meet compliance and regulatory guidelines and company policies
• Delivering marketing operating expenses within budget

Ideal Candidate Profile 

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:

• Bachelor’s degree required; MBA preferred
• Deep understanding of customer adoption behavior in breast cancer
• Knowledge of the laws and regulations regarding interactions with the healthcare community

Experience:

• Minimum of 8 years of progressive commercial experience at biotechnology and/or pharmaceutical companies
• Successful history of developing and executing marketing strategy plans and leading the launch of new oncology products in the US
• Demonstrated ability to leverage insights and analytics to deliver impactful marketing strategies and tactics
• Ability to influence effectively across an organization at all levels
• Experience developing strategies to win in competitive markets
• Experience thriving in a small company environment, with a hands-on and pragmatic leadership style
• Excellent prioritization skills to deliver results within reasonably established timelines

Attributes:

• Team player and collaborative: puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Possesses a get-the-job done attitude and identifies not just challenges but takes the initiative to identify solutions
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent written verbal and interpersonal communication skills and ability to adapt communication styles to varied internal and external partners
• Impeccable professional ethics, integrity, and judgment

The base pay range for this position is expected to be $250,000 - $285,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-AD1

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

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: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 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.

#LI-MT1

About the Role >>> Director, CMC Drug Substance Manufacturing

As the Director, CMC Drug Substance Manufacturing reporting to the Sr Director, Drug Substance Development and Manufacturing, you will provide technical leadership and hands-on execution to support late-stage development, technology transfer to CDMOs, and commercial readiness including NDA filing for small molecule drug substances. This role is critical to ensuring successful scale-up, validation, and regulatory approval of drug substance processes. The individual will work cross-functionally and externally with CDMOs to deliver robust, compliant, and efficient manufacturing processes suitable for commercial supply.

This role is based out of our Dublin, Ireland office and will require 10-15% travel.

Your work will primarily encompass: 

• Lead technology transfer of drug substance processes (RSM/API) to CDMOs, including strategy, execution, and risk management to support late-stage development and commercial manufacturing 
• Provide technical oversight of CDMO activities, including process validation, manufacturing campaigns, and on-site support; serve as the primary technical point of contact 
• Review and approve key manufacturing and development documentation (batch records, protocols, reports, specifications, and deviations) to ensure compliance and data integrity 
• Lead deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs) to support reliable manufacturing performance 
• Drive process robustness, control strategy development (e.g., DOE, PAR), and PPQ readiness to enable successful validation and commercial supply 
• Leverage process and manufacturing data to enhance process understanding, monitor performance across sites, and identify opportunities for continuous improvement 
• Support commercial supply readiness, including supply continuity, cost of goods optimization, and lifecycle management activities 
• Author and review CMC sections of IND/NDA submissions, and support regulatory interactions, responses, and inspection readiness 
• Identify technical risks and proactively develop mitigation strategies to ensure timelines for NDA filing and commercial launch are achieved 
• Partner cross-functionally with Quality, Regulatory, Analytical, Drug Product, and Supply Chain to ensure aligned execution and compliance with global regulatory requirements 

Ideal Candidate Profile >>>  

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 and experience: 

• Ph.D. in Organic Chemistry or related discipline with ~10+ years of experience (or M.S. with ~15+ years) in small molecule CMC drug substance development and manufacturing 
• Demonstrated experience leading technology transfer, scale-up, and validation of API processes to GMP manufacturing sites for late-stage and commercial programs 
• Strong experience managing CDMOs, including vendor selection, technical oversight, and delivery of manufacturing campaigns aligned with quality, timeline, and cost objectives 
• Proven success authoring and reviewing CMC sections of INDs, IMPDs, and NDAs/MAAs, and supporting regulatory interactions and responses with health authorities 
• Strong technical foundation in small molecule process development, manufacturing, and control strategy, including DOE, PAR, and impurity control (e.g., fate and purge) 
• Deep understanding of cGMP requirements and global regulatory expectations (ICH guidelines), with experience supporting inspection readiness and compliant manufacturing execution 
• Demonstrated ability to identify technical risks and apply risk-based decision-making to drive timely and practical solutions 
• Experience integrating process and manufacturing data to support process understanding, trend analysis, and continuous improvement 
• Strong project management and communication skills, with the ability to influence cross-functional teams and external partners in a matrixed environment 

Attributes: 

• Curious, scientifically rigorous, and proactive with a strong “can-do” mindset 
• Self-motivated and accountable, able to work independently and drive results 
• Effective collaborator across cross-functional teams and external partners 
• Highly analytical and detail-oriented, with a data-driven approach 
• Organized and execution-focused, able to manage multiple priorities and timelines 
• Committed to high scientific, quality, and ethical standards while driving continuous improvement 

#LI-MK1

About the Role >>> Associate Director, GMP Quality – Qualified Person

As the Qualified Person (QP), reporting to the Senior Director, Quality Assurance based in San Francisco, California, USA you will hold responsibility for ensuring that Clinical and Commercial medicinal products are manufactured, tested and released in compliance with applicable regulatory requirements of the European Union. You will also ensure that the products are prepared for certification by QPs of the United Kingdom and Israel and are compatible with U.S requirements.

You will be responsible for conducting Supplier and Contract Service Provider audits within the European Economic Community and other geographies. You will monitor changes to European regulatory requirements and host any inspections conducted by the Health Product Regulatory Authority (HPRA) or other Competent Authorities of the European Union. You will be an integral participant in annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews (APRs) following commercial launch. You will work closely with our European CDMOs may also support the processing of European Product Complaints.

This role is based out of our Dublin, Ireland office location and will require up to 25% travel, including some international.

Your work will primarily encompass:

Batch Certification

• Ensure all manufacturing and testing activities comply with approved procedures, Investigational Medicinal Product Dossiers and regulatory standards
• Ensure that outsourced manufacturing and testing activities meet GMP and quality standards
• Act as the legally accountable person for batch certification (as per Directive 2001/83/EC, where applicable)
• Certify and release batches of medicinal products in accordance with EU GMP, Marketing Authorization (MA), and regulatory requirements

Supplier Quality Management

• In conjunction with U.S. based Compliance functions, provide Supplier and CSPs quality and compliance oversight
• Establish appropriate assessment mechanisms, risk-based controls, and monitoring and feedback loops to ensure compliant, effective oversight
• Serve as a resource for the conduct of audits and other assessments of both suppliers and business partners
• Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)

And will also include:

Inspection Readiness

• Establish and maintain the infrastructure and processes required to prepare Olema’s European affiliate for HPRA and other Competent Authorities of the European Union
• Utilize electronic systems, including Artificial Intelligence–enabled tools, to support inspection readiness activities
• Utilize Inspection Management Software to ensure consistent and reliable inspection preparation and response
• Perform Mock Inspections at European Suppliers / CSPs / Partners

Regulatory Intelligence and Monitoring

• Monitor local and European regulatory authorities for proposed GMP rulemaking and or trends in regulatory inspections
• Monitor inspectional status and compliance trends within the Olema European Supplier and CSP network

Annual Reviews and Quality System Leadership

• Participate in the annual Quality Management Review process
• Participate in the execution of Annual Product Quality Reviews upon commercial product launch
• Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions on European topics

As this is a new office, there may be other assignments and projects as required.

Ideal Candidate Profile >>>

A strong contributor with in-depth knowledge. A confident professional with a solid understanding of EU and UK regulatory GMP compliance requirements. A team-oriented individual with solid ability to communicate across multiple time zones, strong work ethic, optimism, and commitment to meaningful contributions. As such, we are looking for someone with the right combination of qualifications, knowledge, experience, and attributes for this role.

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.

Qualifications

• Eligible to act as a Qualified Person under EU legislation (Directive 2001/83/EC)
• Pharmaceutical Quality System (PQS) Auditor certification is highly preferred

Knowledge

• Bachelor's degree in pharmacy, chemistry, biology or a related scientific field is required
• Strong understanding of EU and Rest-of-World (ROW) regulatory and compliance requirements
• Demonstrated experience in Supplier Compliance and Inspection Management
• Firm knowledge of GMPs, GDPs and Quality Management Systems
• Experience using Inspection Management Software

Experience

• Minimum 10 years of experience in Biopharmaceutical industry
• Minimum 7 Years of experience in Supplier Quality Management
• Minimum 3 Years of experience with Oral Solid Dosage forms
• Minimum 4 Years of experience in a Qualified Person role
• Oncology experience is desirable

Attributes

• Self-directed and capable of independently setting and managing priorities
• Able to adapt to a rapidly changing organization characterized by ambiguity and evolving process definition
• Demonstrates strong cross-functional collaboration, and communication skills
• Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
• Critical thinking, able to identify the gates required for QP certification
• Passionate about meaningful work and contributing to patient-focused outcomes

#LI-MK1

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

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: 

• Bachelor's degree required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
• Collaborating and interacting with external vendors/CDMOs. 
• Experience preparing materials for team or leadership meetings. 

Attributes: 

• Highly organized with strong attention to detail and follow-through. 
• Energetic, proactive, and action-oriented — a true “go-getter.” 
• Friendly and approachable with a collaborative mindset. 
• Strong communicator who can tailor messaging to diverse audiences. 
• Skilled at bridging functions and building strong working relationships. 
• Comfortable navigating a fast-paced, evolving environment. 
• Solutions-oriented with sound judgment and appropriate escalation. 
• Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 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.

#LI-MT1

About the Role >>> Senior Clinical Trial Associate 

As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. 

This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel. 

Your work will primarily encompass: 

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct 
• Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors 
• Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
• Conducts oversight of sample collection, shipment, and analyses 
• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead 
• Identifies potential risks and proactively resolves issues with CROs 
• Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) 
• Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information 
• Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents  
• Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms. 
• Coordinates electronic distribution and/or shipment of study-related materials, as appropriate  
• Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed 
• Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)  
• Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations 
• Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes

Ideal Candidate Profile >>>   

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

• Bachelor’s degree is required 
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred 
• Working knowledge of clinical protocols 

Experience

• Minimum of 3 years of related industry experience is required 
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate. 
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) 
• Experience with leading small group meetings and/or managing vendor relationships 

Attributes

• Highly motivated and enjoys working in a fast-paced, dynamic environment 
• Excellent teamwork and collaboration skills 
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail 
• Excellent written and verbal communication skills 
• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed 

The base pay range for this position is expected to be $110,000 - $120,000 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-CK1

About the Role >>> Senior Scientist, Medicinal Chemistry 

As the Senior Scientist, Medicinal Chemistry reporting to the Associate Director of Medicinal Chemistry, you will design and synthesize novel small molecules as part of ongoing research program hit-to-lead and lead optimization efforts. You will have the opportunity for strong scientific collaboration with the internal medicinal chemistry team and will provide scientific oversight of external resources involved in the design and synthesis of novel small molecule drug candidates.  You may lead the organic chemistry function within multidisciplinary project teams to help advance drug discovery projects from inception to the clinic in support of our mission to deliver novel medicines to the cancer patients who need them.  

 This role is based out of our San Francisco Bay Area Laboratory and will require 5% travel. 

 Your work will primarily encompass: 

• Performing hit-to-lead and lead optimization by designing and synthesizing novel small molecules. 
• Supporting and guiding external chemistry resources by designing synthetic strategies, prioritizing targets, and proposing creative solutions to chemistry problems. 
• Advancing novel small molecule hits and lead compounds into clinical candidates by leveraging structure-based drug design, and/or multi-parameter lead optimization. 
• Effectively communicating scientific results and progress. 

And will also include: 

• Collaborating with internal biology and pharmacology teams, CROs, and consultants, including DMPK scientists and CADD experts. 
• Communicating project results and progress to key internal stakeholders. 
• Developing internal talent by providing positive mentorship while fostering a culture of collegiality, accountability, and scientific rigor. 
• Partnering with internal colleagues and external collaborators in cross-functional teams to ensure efficient progression of new compounds through assay workflows. 
• Assisting in writing scientific manuscripts/posters in support of Olema’s publication strategy. 
• Active participation in laboratory safety and environmental initiatives. 

Ideal Candidate Profile >>>  

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: 

• Ph.D. in Organic or Medicinal Chemistry. 
• Strong knowledge of state-of-the-art synthetic organic chemistry methodology and possess outstanding synthetic trouble-shooting skills. 
• Working knowledge of structure-based drug design as demonstrated by publications or patents. 

Experience: 

• Minimum of 5 years as a medicinal chemist in the pharmaceutical or biotechnology industry. 
• Proven experience collaboration with and supporting external medicinal chemistry FTEs. 
• Demonstrated proficiency in computational modeling software and cheminformatics tools (e.g., Maestro, MOE) 
• Experience with chemical databases such as Dotmatics a plus. 
• Protein Degrader experience a plus. 

Attributes: 

• Have impeccable professional ethics, integrity, and judgment. 
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization.  
• 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. 
• Be a “difference maker” in terms of ones’ professionalism and contributions. 
• Strong verbal and scientific writing skills to effectively share information with a wide range of internal and external audiences.

The base pay range for this position is expected to be $160,000-$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-MT1