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Program Manager, CMC

Olema Oncology

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond . You can view our latest corporate deck and other presentations here . About the Role >>>Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management,you willlead integrated CMC program planningand execution across clinicaldevelopment stages.You willtranslate CMC strategy into actionable, integrated plans that enabletimelyclinical and regulatoryprogress.This role is highly cross-functional and requires close collaboration with Technical Operations (CMCtechnical leads), Quality, Regulatory, Supply Chain,Financeandexternalpartners.You will serve asan operationalleader–driving accountability,facilitatingalignment,managing risk,and helping teams navigate challenges effectively. This rolecan bebased out of ourSan Francisco, CA or Boston, MAofficesand will require 10% travel . Your work willprimarilyencompass: 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 andmaintainintegrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. Identifyprogram risks, drive mitigation planning with functional leads, and elevate issues as needed tomaintaintimelines. FacilitateCMCsub-team meetings, documentdecisionsand action items, and ensure follow-through across internal teams and external partners. Prepare leadership-ready status updates and presentations, track key program metrics, andmaintainclear 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 proactivelyidentifyrisks 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. IdealCandidate 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 accomplishingour mission and building a positive company culture. As such, we are looking for someone with the right combination ofknowledge,experience, andattributes for this role. Knowledge: Bachelor's degree required, Life Sciences orrelateddisciplines preferred. ProficiencyinMicrosoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). KnowledgeofCMC development processes across clinical stages. Familiaritywith regulatory submission timelines and CMC documentation requirements preferred. Experience: Minimum5+yearsof experienceinlife sciences programmanagement and/ordrug developmentoperationswith 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 developmentteams(Drug Substance, Drug Product, Analytical, Quality,Regulatory Affairs, Supply chain). Demonstrated experiencebuilding and managing integrated project plans,identifyingcritical 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 andappropriate escalation. Strong teamplayer 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. We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncologyand make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is pelas.com ; our careers page isolema.com/careers ; our LinkedIn page islinkedin.com/company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront paymentsof any kind, and does not make job offers without an in-person interview. #J-18808-Ljbffr Olema Oncology

Vacancy posted 3 days ago
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