# Associate Director, Global Regulatory Affairs, Compliance and Project Management at Olema

- Company: Olema
- What the company does: Olema Oncology is a clinical-stage biopharmaceutical company developing novel therapies to transform treatment for metastatic breast cancer and beyond. Backed by Lightspeed.
- Company website: https://olema.com/
- Type: Startups
- Level: Principal and up
- Location: Boston, Massachusetts
- Work setup: On-site
- Pay: $185K to $205K base salary per year (USD)
- Posted: 2026-08-25
- Apply by: 2026-10-09
- Apply: https://job-boards.greenhouse.io/olema/jobs/6100066004
- Page: https://www.1752.vc/careers/jobs/olema-associate-director-global-regulatory-affairs-compliance-and-project-manage-2/

## About the role

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028.

## What they're looking for

- Bachelor’s degree in a scientific or related discipline, an advanced degree is preferred
- 8+ years of Regulatory Compliance and Project Management experience within the pharmaceutical or biotechnology industry
- Demonstrated skills to interpret and apply applicable laws, regulations, and regulatory guidance to manage compliance
- String interpersonal skills with the ability to work with cross functional project teams
- Required experience in technical and regulatory writing
- Proven ability to independently plan, prioritize, and accomplish goals using sound judgment

Tags: Clinical