Olema Oncology is a cancer medicines company focused on developing innovative treatments for breast cancer and other malignancies. Led by palazestrant (OP-1250), a complete estrogen receptor antagonist, and OP-3136, a KAT6 pathway inhibitor, the company aims to create more effective therapies that improve patient outcomes. Olema's team is dedicated to its mission of developing better medicines with clarity and intention.
Open Positions
Submission Content Manager, Regulatory Affairs Operations
3+ years experience in Regulatory Affairs, experience with eCTD submissions, knowledge of enterprise document management systems
Associate Director, GCP Quality Assurance
Bachelor's degree in a scientific discipline, 8 years of relevant experience in Quality Assurance, and in-depth knowledge of GCP, EU, FDA, and ICH regulations and guidelines
Submission Content Manager, Regulatory Affairs Operations
Bachelor's degree, 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
Program Manager, CMC
Lead integrated CMC planning, build and maintain project timelines, and identify program risks
Senior Director of Accounting & Assistant Controller
10+ years of accounting experience, Public company experience in the Biotechnology industry, Big 4 public accounting experience
Director, Clinical Monitoring Oversight
Bachelor's or Master’s degree in a scientific discipline or a related scientific field, 12 years of clinical operations experience, and 5 years direct site monitoring experience required
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Bachelor's in Science or a Master's. 12+ years regulatory experience in Pharma/Biotech, minimum 3+ years leadership. Strong understanding of FDA, EU & international guidelines is key
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Bachelor's degree in science. 12+ yrs Pharma/Biotech experience, 3+ yrs of direct leadership experience. Strong understanding of FDA/EU and international regulatory guidelines
Director, Clinical Monitoring Oversight
12 years of clinical operations experience, 5 years direct site monitoring experience, and 5 years global monitoring oversight experience
Program Manager, CMC
Bachelor's degree in Life Sciences, 5+ years of experience in life sciences program management, and familiarity with regulatory submission timelines
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