About the job
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 Assurance
As 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...