# Director, Safety Sciences 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
- Posted: 2026-07-02
- Apply by: 2026-10-08
- Apply: https://job-boards.greenhouse.io/olema/jobs/6107021004
- Page: https://www.1752.vc/careers/jobs/olema-director-safety-sciences-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

- Minimum of 8+ (MD, PhD, PharmD) or 10+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry
- Late phase clinical development and registration experience, NDA/BLA submissions and submission readiness planning
- Experience with clinical safety data integration and ISS authoring/review
- Proven experience with benefit-risk assessments and regulatory justification
- Experience with labeling negotiations and safety labeling strategy
- Demonstrated success leading health authority meeting preparation and regulatory responses

Tags: Clinical