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  

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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.

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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 

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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

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