Program Manager, CMC at Olema Oncology | Boston, MA

At Olema Oncology, our mission is to revolutionize the landscape of breast cancer treatment and beyond. We are at the forefront of drug development with our lead candidate, palazestrant (OP-1250), a complete estrogen receptor antagonist (CERAN) currently being developed for metastatic breast cancer. This innovative therapy has the potential to become a blockbuster, both as a standalone treatment and in combination with other therapies for ER+/HER2- metastatic breast cancer. Additionally, we are developing OP-3136, a powerful KAT6 inhibitor that showcases best-in-class potential.Our progress is fueled by a culture of fearless support, motivation, and collaboration. At Olema, we prioritize our people, ensuring that our efforts lead to groundbreaking advancements in patient care. If you are eager to be part of a transformative journey that impacts patients, propels your career, and expands the horizons of oncology, we welcome you to join our dynamic team.Explore our latest corporate presentations here.About the Role: Program Manager, CMCAs the Program Manager, CMC, you will report to the Director of CMC Program Management and be pivotal in leading integrated CMC program planning and execution throughout clinical development stages. Your role will be to convert CMC strategies into actionable, cohesive plans that facilitate timely clinical and regulatory advancements. This position demands extensive cross-functional collaboration with teams from Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance, and external partners. You will be recognized as an operational leader, responsible for driving accountability, fostering alignment, managing risks, and guiding teams through challenges effectively.This position may be located in either our San Francisco, CA or Boston, MA offices, with a requirement for 10% travel.Your primary responsibilities will include:Leading integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), collaborating with Director- and Senior Director-level leaders to define deliverables, timelines, and priorities that align with clinical and regulatory objectives.Developing and maintaining integrated project timelines using Smartsheet or similar tools to ensure project milestones are met efficiently.

At Olema Oncology, we are committed to pioneering advanced therapies for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is an innovative complete estrogen receptor antagonist (CERAN) currently undergoing development for metastatic breast cancer, showing significant promise as both a monotherapy and in combination therapy for ER+/HER2- metastatic breast cancer. Additionally, our next candidate, OP-3136, is a leading KAT6 inhibitor with potential to set new standards in treatment.Our scientific advancements are driven by an environment that encourages fearless support, motivation, and collaboration. At Olema, we believe that prioritizing our team leads to exceptional outcomes. If you are prepared to be part of something transformative, let’s collaborate to create meaningful impacts for our patients, your career, and the future of medicine.For more insights, view our latest corporate presentations here.About the Role: Senior Director, Global Regulatory Strategy Lead - Regulatory AffairsIn the position of Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs, reporting to the Senior Vice President of Regulatory Affairs, your key responsibilities will include:Leading the development of the New Drug Application (NDA).Creating and implementing innovative regulatory strategies that support Olema's product portfolio.Acting as the subject matter expert for Regulatory Affairs on cross-functional teams, providing guidance to global project teams, Study Execution Teams, and the Executive Committee.Offering strategic and tactical oversight for the development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.This role is based in either our Boston, MA or San Francisco, CA office and will involve domestic and international travel of up to 20%.This role will primarily involve:Leading the NDA development and submission for our lead programFormulating innovative global regulatory strategies for the Olema product suite, addressing both clinical development and lifecycle management as required.Representing Regulatory Affairs on cross-functional teams as the SME, delivering regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.

Olema Oncology is dedicated to advancing new treatments for breast cancer, with a focus on therapies such as palazestrant (OP-1250), a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer. The company’s pipeline also includes OP-3136, a KAT6 inhibitor. Olema’s team works in an environment that values support, motivation, and challenge, all aimed at driving scientific progress and meaningful outcomes for patients. Role overview The Vice President of Quality Assurance leads Olema’s global quality strategy and governance across the entire product lifecycle. This includes oversight of clinical development, manufacturing, pharmacovigilance, and commercial operations. As the senior Quality representative at the executive level, this leader ensures a risk-based approach tailored to the needs of oncology drug development, with a strong focus on patient safety, data integrity, and timely execution. The Vice President operates with significant autonomy, collaborating closely with leaders across the company and guiding the established Quality leadership team in GCP, GMP, and GPV. Setting priorities, driving execution, and maintaining inspection readiness are central as Olema advances toward late-stage development. This position is based in Boston, MA or San Francisco, CA, and requires some travel. Key responsibilities Develop and implement a pragmatic, phase-appropriate, and cohesive Quality strategy that aligns with Olema’s pipeline and corporate goals. Act as the senior authority for Quality within the organization, establishing standards and practices to support ongoing and future initiatives. For more information on Olema Oncology’s work and updates, see their corporate presentations.

At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a comprehensive estrogen receptor antagonist (CERAN) currently undergoing development for metastatic breast cancer, showcasing immense potential both as a standalone therapy and in combination for ER+/HER2- metastatic breast cancer. Additionally, our subsequent candidate, OP-3136, is a robust KAT6 inhibitor with the potential to set new standards in its class.Our scientific advancements are propelled by a culture that prioritizes fearless support, motivation, and mutual challenge among our team members. We believe that placing our people at the forefront allows us to achieve unparalleled results. If you are eager to be part of an unstoppable force, let's collaboratively make a significant impact for our patients, your career, and beyond.You can explore our latest corporate presentations here.About the Role: Associate Director of Clinical Supply ChainAs the Associate Director of Clinical Supply Chain, reporting directly to the Senior Director, you will be instrumental in planning, creating, implementing, and optimizing the clinical supply chain to guarantee a seamless and timely supply of clinical drugs for Olema's innovative programs.This role is positioned in our Boston office and will necessitate approximately 15% domestic or international travel.Your responsibilities will encompass:Comprehensive management of the clinical supply chainDevelopment and execution of global Clinical Supply Chain strategiesOversight of global inventories, shipping, and engagements with third-party manufacturers and logistics providersCreation and management of Interactive Response Technologies (IRT) systemsSupervision of packaging, labeling, and distribution tasks at various vendor locationsGeneration and management of clinical labelsIdentification of supply chain risks, escalation as necessary, and resolution of risk itemsCollaboration with Clinical Operations to ensure alignment on assumptions and the development of clinical supply to meet program demandsRepresentation of Clinical Supply Chain on study execution teams

At Olema Oncology, we are committed to advancing innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently being developed to target metastatic breast cancer, demonstrating significant potential as both a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, our second product candidate, OP-3136, is a powerful KAT6 inhibitor poised to set a new standard in its class.Our scientific achievements are fueled by a culture of fearless collaboration, support, and motivation. At Olema, we believe that prioritizing our team leads to unparalleled results. If you're eager to be part of a groundbreaking journey that will profoundly impact our patients, your career, and the future of oncology, we invite you to join us.For more insights into our corporate vision, you can view our latest presentations here.About the Role: Associate Director of GCP Quality AssuranceAs the Associate Director of GCP Quality Assurance, you will report directly to the Senior Director of GCP Quality Assurance. In this pivotal role, you will collaborate with Clinical Development, Operations, Pharmacovigilance, and Safety teams within cross-functional study teams to ensure compliance with Good Clinical Practice (GCP) and Good Vigilance Practice (GVP). Your responsibilities will include identifying and communicating risks associated with clinical trials, proposing process improvements, reviewing and approving study-related documents and plans, and facilitating audits.This hybrid position will be based in either our San Francisco, CA or Cambridge, MA office, with a travel requirement of up to 20%.Your primary responsibilities will include:Conducting internal and external audits to ensure adherence to GCP/GVP regulations and guidelines.Overseeing GCP/GVP auditing activities, which include audit preparation, execution, report generation, and follow-up on findings and observations, including corrective and preventive actions (CAPAs), while effectively communicating results to internal stakeholders.Collaborating with Quality Assurance...

Role overview Olema is hiring a Senior Manager of Legal Operations and Contracts based in Boston, Massachusetts. This position plays a key role in shaping and strengthening legal processes while overseeing contract management throughout the organization. The focus is on building effective legal workflows and ensuring compliance in all contract activities. What you will do Lead efforts to refine and improve legal operations across Olema Manage the full contract lifecycle, from initiation to completion Develop and implement initiatives that enhance compliance and operational efficiency Requirements Proven experience managing legal operations and contracts Strong strategic thinking, with a focus on process improvement Demonstrated ability to maintain compliance in all contract-related matters

Join Formlabs as a Senior Technical Program Manager, where you will lead and coordinate technical projects that drive innovation and efficiency.In this role, you will work closely with cross-functional teams to ensure that projects are delivered on time and meet high-quality standards. Your expertise in program management and technical understanding will be essential in navigating complex challenges and ensuring alignment across multiple stakeholders.

Join our dynamic marketing and communications team as a Digital Marketing Specialist at JVS Boston! In this pivotal role, you will assist in crafting engaging content, driving program outreach, supporting events, and performing various essential tasks. Your contributions will be vital in promoting JVS Boston’s diverse program offerings, managing our vibrant social media presence, and designing impactful digital and print materials that align with our communication and marketing strategy.We seek a creative individual with a keen eye for aesthetics and a solid background in graphic design, photography, social media campaigns, and versatile writing tailored for diverse audiences. As part of our Advancement department, you will play a crucial role in client-facing outreach and donor engagement efforts.

At WHOOP, we are dedicated to revolutionizing human performance and extending health spans. We empower our members to achieve their peak potential through a profound understanding of their bodies and daily routines.As the Operations Program Manager, you will spearhead cross-functional manufacturing initiatives that enhance and innovate production processes throughout WHOOP’s global supply chain. Collaborating closely with Manufacturing, Supply Chain, Factory, Test, and Quality teams, your efforts will focus on delivering pivotal projects that boost product quality, throughput, cost-efficiency, and operational readiness.This position is based at our headquarters in Boston, MA, and is crucial for scaling and maintaining high-performance manufacturing through systematic execution, robust cross-functional collaboration, and a proactive approach to problem-solving.

Are you ready to transform the landscape of molecular diagnostics?Become part of an extraordinary team of passionate visionaries at BillionToOne, dedicated to revolutionizing healthcare. Our unique culture is built on transparency, trust, and collaboration, allowing innovative minds to thrive. We aim to create diagnostics that are not just improvements but are exponentially better than current solutions. Our workforce—comprising talented scientists, engineers, sales specialists, and forward-thinkers—is united by the goal of redefining the standard of care in prenatal and cancer diagnostics. Join us in making life-changing diagnostics accessible to all, where every innovation you contribute alleviates the fear associated with critical medical decisions. If you have a strong sense of purpose, are inspired by innovation, and are eager to shape the future of precision medicine, your place is with us.We are seeking a field-based Oncology Account Executive in Boston who possesses scientific and clinical acumen to support our oncology portfolio of liquid biopsy products. This role is pivotal in driving sales for BillionToOne’s Northstar Liquid Biopsy offerings and fostering relationships with oncologists and the broader cancer care community within the designated area. This position reports to the Regional Manager - Oncology.

About SimpliSafeAt SimpliSafe, we are dedicated to revolutionizing home security. Our mission is to ensure the safety of every home, and we highly value the careers of our team members. Our workplace fosters a culture of collaboration and innovation, where individuals are encouraged to tackle challenges head-on and make a significant impact. We don’t just want you to work here; we want you to flourish and develop your career with us.We embrace a hybrid work model that allows our teams to balance time between the office and home. Typically, we ask our team to collaborate in our state-of-the-art office on two core days—usually Tuesday, Wednesday, or Thursday—while enjoying the flexibility to choose their work location for the rest of the week. This model provides the best of both worlds, maximizing productivity and work-life balance.Why Join Us?Our continuous growth necessitates the addition of talented, intelligent, and humble individuals who align with our values. Together, we aim to disrupt the home security industry and fulfill our mission of protecting every home.Your RoleWe are seeking a Principal Technical Program Manager to enhance our Engineering team's capabilities in delivering customer-centric product features and improvements. As the fastest-growing home security provider in the U.S., we are competing against established giants like ADT and tech behemoths such as Amazon and Google. To succeed in the expanding IoT home automation security market, we must learn rapidly, collaborate effectively, and innovate creatively. Our engineering team is proud to manage the entire 'full stack', from designing and building hardware circuit boards to coding user interfaces for our mobile applications.At SimpliSafe, we champion a ‘no-ego’, collaborative culture, earning recognition as a 'Top Place to Work' in 2021 by the Boston Business Journal. We strive to solve complex challenges in the home security and IoT sectors while continually evolving to provide our employees with the best possible work experience. If SimpliSafe resonates with you, we would love to connect!In this position, you will collaborate closely with engineering leadership to drive process improvements within the engineering department while ensuring alignment with company goals and facilitating communication with the Executive Team and Board of Directors.

About the Role:As the Chief Financial Officer (CFO) at Jewish Vocational Services Inc. (JVS), you will play a pivotal role in shaping our financial strategy and ensuring the sustainability of our mission-driven initiatives. You will oversee financial planning, risk management, record-keeping, and financial reporting, while working closely with the executive team to drive operational efficiency and fiscal integrity.

At Olema Oncology, we are committed to innovating and advancing the field of breast cancer treatment and beyond. Our flagship program, palazestrant (OP-1250), is a pioneering complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer, showcasing significant potential as both a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, our subsequent product candidate, OP-3136, is a KAT6 inhibitor that stands out as best-in-class.We believe that our scientific achievements are propelled by a collaborative environment where we support, inspire, and challenge each other. At Olema, prioritizing the well-being of our team translates into exceptional results. If you are ready to be part of a transformative journey that deeply impacts the lives of our patients and enhances your career, we invite you to join us.For more insights, please check our latest corporate presentations here.About the Role: Senior Manager, Quality Document Control and ComplianceThe Senior Manager of Quality Document Control and Compliance will be a key player in our operations, reporting directly to the Director of Quality Systems. This role will oversee the daily operations of Veeva Vault QDocs, leading document management processes and ensuring compliance standards are met. Responsibilities include but are not limited to the creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs), and GXP documentation, as well as overseeing GXP record processing and archival. You will also be responsible for maintaining document control compliance KPIs and generating metrics for management review.This position is based in our Boston, Massachusetts office and may require approximately 15% travel.Your primary responsibilities will encompass:Acting as the Veeva Vault QDocs Administrator and document control manager.Processing document change control (DCC) for GxP controlled documents in Veeva.Formatting finalized documents to adhere to effective templates.Proofreading and finalizing documents for processing in Veeva QDocs.Collaborating closely with various functional areas to develop, update, manage, and maintain GxP controlled documents.

We are seeking an experienced Associate Director of Global Regulatory Strategy to drive our international regulatory initiatives. This pivotal role will involve developing and executing regulatory strategies for our innovative therapies aimed at treating serious diseases. You will collaborate closely with cross-functional teams to ensure compliance and facilitate the successful progression of our clinical programs.

Join the Quality Development Program at InterSystems, a leading provider of advanced data management and analytics solutions. This program is designed for individuals who are passionate about ensuring the highest standards of quality in software development. You will engage in hands-on projects, collaborate with experienced professionals, and gain valuable insights into quality assurance processes.

About Merlin Labs: Merlin Labs is an innovative aerospace startup, backed by prominent venture capital, dedicated to developing autonomous pilot systems that facilitate both crewed and uncrewed flight operations. With support from leading global investors, we are collaborating with our clients to harness autonomy today and tackle some of the most significant challenges in aviation.About You: As a Senior Program Manager at Merlin Labs, you will be a strategic leader with extensive program management expertise, focused on driving mission-critical outcomes. You will oversee a suite of impactful customer-oriented defense and autonomy programs, guiding them from initial capture through to successful deployment and operational integration.Your unique combination of technical proficiency, stakeholder engagement, and operational discipline makes you an invaluable asset in fast-paced environments characterized by ambiguity and the need for swift execution. You excel at deeply understanding military operator requirements, converting them into actionable technical and programmatic priorities, and leading teams to achieve meaningful results. If you are passionate about influencing the future of aviation while fostering lasting customer partnerships, we would be thrilled to connect with you.

The Alliance for Clinical Trials in Oncology Foundation is dedicated to advancing cancer clinical research by expanding the capabilities of the Alliance for Clinical Trials in Oncology. Our mission is to address significant treatment challenges through large-scale clinical trials aimed at discovering innovative methods for the prevention, treatment, and cure of various cancers, including leukemia, lymphoma, and solid tumors such as breast, prostate, lung, and gastrointestinal cancers. We also strive to educate the medical community on effective cancer diagnosis, treatment, and prevention strategies.In 2014, we established the Alliance Foundation Trials, LLC (AFT), a wholly-owned subsidiary focused on conducting impactful cancer clinical research in collaboration with industry partners.We are currently seeking a Clinical Research Associate (CRA) to play a crucial role in the management and execution of clinical trial operations across AFT studies. The CRA will be responsible for site management and study start-up activities, including conducting feasibility assessments, supporting site selection, maintaining trial master files (eTMF), and overseeing clinical trial management systems (CTMS). The ideal candidate will work closely with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards throughout the study lifecycle. Join our team of dedicated professionals passionate about transforming cancer care.

One Medical has provided primary care for over 15 years, combining in-person and 24/7 virtual visits, on-site labs, and support for preventive care, chronic conditions, and mental health. Now part of Amazon, One Medical continues to expand its reach and welcomes team members from all backgrounds. Role overview This Medical Assistant role, also known as Lab Services Specialist or Member Support Specialist, is based in Boston, MA. The position focuses on creating a smooth, welcoming experience for every patient who walks through the door. Medical Assistants handle venipuncture, offer clinical support, and guide patients through their care. Keeping the office lobby inviting and aligned with the One Medical brand is also part of the daily routine. What you will do Perform venipuncture and assist with clinical tasks Act as a patient ambassador to ensure a positive visit Support the Practice Coordinator, Operations Manager, and healthcare team Help maintain the appearance and atmosphere of the office lobby Identify ways to improve the patient experience and suggest solutions Communicate clearly with patients and colleagues, both in person and in writing Work collaboratively and adapt to feedback and changing needs Requirements Strong interpersonal skills and a commitment to service Ability to collaborate and solve problems with empathy Self-awareness and motivation for personal growth Comfort working in a feedback-driven, team-based setting Dedication to creating memorable experiences for patients and coworkers

About Merlin Labs: Merlin Labs is an innovative aerospace startup focused on revolutionizing aviation through the development of a non-human pilot. Our mission is to enhance both crewed and uncrewed flight capabilities. Supported by some of the most prestigious investors in the industry, we are committed to scaling our technologies alongside our customers to address significant challenges in aviation using autonomy.About You: You are a dedicated builder who excels at the crossroads of technology, execution, and meaningful impact. As a Technical Program Manager at Merlin Labs, you will be pivotal in realizing our autonomy technology—bringing the Merlin Pilot into operational service on military aircraft and leading ambitious aerospace programs.Working closely with our dynamic autonomy and flight systems teams, you will collaborate with engineers, business stakeholders, and customer teams to ensure technical progress and cross-functional alignment. You possess technical fluency, a structured approach to problem-solving, and the ability to clarify complex issues. You thrive on tackling difficult challenges, embrace uncertainty, and are relentless in achieving results.This role is central to Merlin's mission and marks a critical phase in our growth. You will manage a diverse portfolio that includes internally funded R&D initiatives and customer programs. Above all, you are passionate about our mission: accelerating autonomy, supporting our warfighters, and redefining aviation possibilities.Join us in building the future of flight—let's make it a reality, one milestone at a time.

Job Overview:As a Store Manager, you will play a crucial role in overseeing store operations in the absence of the Store Director. Your leadership will drive total store sales, profit, and expense management.Lead the Grocery, Drug, and Fresh Departments effectively.Key Responsibilities:Foster a customer-centric environment that emphasizes personalized service while addressing customer concerns in the absence of the Store Director.Provide guidance and mentorship to all store associates, ensuring that Department Managers are well-trained and supported.Manage the hiring process for grocery and drug department roles.Take accountability for the store's profitability through rigorous cost control and P&L analysis.Ensure effective merchandising strategies are followed to enhance product visibility and sales performance.Assess labor needs based on sales forecasts and market trends, scheduling associates accordingly.Maintain optimal inventory levels in departments, implementing procedures for inventory management.