Serve as the medical safety lead for one or more development programs, guiding global safety strategy, benefit-risk assessment, signal detection, and safety evaluations in a biotech pipeline environment. The role also supports aggregate safety reporting, regulatory submissions, and protocol review while working closely with Clinical, Regulatory, and external partners. This is a hands-on contract position with both strategic and operational responsibilities, and oncology or hematology experience is preferred.
Key Responsibilities
- Lead global safety strategy and benefit-risk assessment for assigned programs.
- Oversee signal detection and safety evaluations.
- Author and review aggregate safety reports, including DSURs and PBRERs.
- Support regulatory submissions such as IND, NDA, and BLA filings.
- Provide safety input into protocols, investigator brochures, and informed consent forms.
- Collaborate with Clinical, Regulatory, and external partners on safety activities.
- Support inspection readiness and health authority interactions.
Required
- MD degree.
- Experience in Drug Safety or Pharmacovigilance.
- Experience as a Global Safety Physician or Medical Director.
- Strong experience with signal detection, aggregate reporting, and regulatory submissions.
Preferred
- Oncology experience.
- Hematology experience.
Benefits & Perks
- 12-month contract with potential to extend or convert to permanent.
- High-ownership, strategic safety role.
- Opportunity to support a growing biotech pipeline.
- Hybrid schedule with 2 days onsite per week.