# Director, Global Regulatory Affairs Strategy Lead 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: San Francisco, California
- Work setup: On-site
- Pay: $230K to $250K base salary per year (USD)
- Posted: 2026-10-15
- Apply by: 2026-11-29
- Apply: https://job-boards.greenhouse.io/olema/jobs/6222767004?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/olema-director-global-regulatory-affairs-strategy-lead/

## 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. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech
- Minimum of 3 years direct leadership experience
- Experience in Oncology Therapeutic area is strongly preferred
- Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions (IND/CTx to NDA/BLA or Marketing Applications)
- Experience with development and execution of regulatory strategies in Oncology TA is strongly p referred
- Ability to work in a fast-paced environment in a hands-on fashion

Tags: Clinical

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/olema-director-global-regulatory-affairs-strategy-lead/