Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role >>> Associate Director, Regulatory Labeling
As the Associate Director, Regulatory Labeling, reporting to the Senior Director, Regulatory Affairs CMC, you will lead the development of labeling for clinical supplies. As a regulatory labeling lead, you will oversee the prioritization, creation, review, approval, and maintenance of clinical labels. This role requires a solid understanding of global labeling requirements, a basic understanding of labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with the Clinical supply (CS), the quality assurance (QA), and the CMC teams and external (clinical research organization) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.
This role will be based out of our San Francisco, CA or Cambridge, MA office and will require 15% travel.
Your work will primarily encompass:
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:
Experience:
Attributes:
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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Important Information >>>
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.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.