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. 

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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. 

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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 >>> 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.

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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.

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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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